Neonatal Medicine

Checking on the well-being of mothers is one of the important acknowledged aspects of primary pediatric care. “How are you doing?” directed to the child’s mother has long been considered an appropriate question. The AAP recommends several checks in the Bright Futures Guidelines, including conducting several formal screens for depression and asking about “getting time alone with your partner” as well as other supports.

But I have recently become aware of new data that changes my ideas about what we pediatricians need to be doing as part of our care for children and their families, especially in the first year: Considering the risks to the mother of dying.

Maternal mortality increased by 26.6% from 2000 to 2014 across the United States such that it is higher now than it was for our own mothers. The U.S. now has the highest rates of maternal mortality among high-income nations, especially for Black, American Indian, or Alaska Native women, those of lower socioeconomic status, and those under 18 or over 35 years old.

You may be thinking, well, that is an issue for ob.gyns. Indeed, the most common reasons for maternal death are cardiovascular: hemorrhage, hypertensive disorders, deep vein thrombosis, and stroke, all usually occurring at or in the first week after birth. You may have heard about sudden unexpected heart failure from postpartum cardiomyopathy, although rare (1 in 1,000-4,000), presenting from 1 month pre birth to 5 months post delivery, which is when we may be the main clinicians seeing the mother, not the ob.gyns. This can be easily missed since it presents with shortness of breath and decreased exercise tolerance, fatigue, palpitations, and/or leg swelling. Serious eclampsia may have only symptoms of headache or abdominal pain. All of these may easily be mistaken for lingering pregnancy symptoms. But in higher income countries, such as the U.S., 38% of maternal deaths occur from 8 to 42 days after birth, the period for fatal infections as well as cardiac complications. Elevated risk for all of these causes of mortality include Black race, obesity, tobacco use, congenital heart disease, and being older than 40.

As pediatric providers, we may see mothers along with their infants as newborns in the hospital, at day 2, at 2 weeks, or even at 1-2 months after birth, potentially before their one recommended postnatal obstetric visit at 3-8 weeks. Asking the mother how she is feeling at those times should not just be a social nicety but rather an additional check for serious postnatal complications.
 

Additional concerns

But wait, it gets worse.

Did you know that the leading cause of maternal death from pregnancy up to 1 year after a birth is homicide?

Maternal perinatal mortality figures have not usually included “perinatal-associated” deaths, a maternal death attributable to a condition that is unaffected by the pregnancy and occurring within 1 year of delivery (that I will cite as perinatal henceforth). While half of maternal deaths occur during pregnancy, another half occur in the year following. There were 3.62 homicides per 100,000 live births among females who were pregnant or within 1 year postpartum, 16% more than for similarly aged nonpregnant and nonpostpartum women (3.12 deaths/100,000 population, P < .05). Homicides made up 8.4% of reported perinatal maternal deaths from all causes, with a rate of 1.7 per 100,000 live births, twice the rate of any one of the other leading causes noted above. Black women had seven times the risk of perinatal homicide as that of White women. Females under 20, many of them our own pediatric patients, had a greater than six times higher risk and those aged 20-24 had a 65% higher risk of pregnancy-associated homicide across race and ethnic groups. Homicide is most likely before 21 weeks of pregnancy, decreases in the third trimester, but increases again after birth. Two-thirds of pregnancy-associated homicide deaths occurred in the home, with the perpetrator a current or prior partner (> 59%, with 98% being male), 45%-50% were associated with reported intimate partner violence (IPV), and the most common method was a firearm (55%). Often the same women had histories of substance abuse, serious mental illness, and/or prior IPV, all risk factors for pregnancy-associated deaths, including from homicide.

Homicide? “Not the mothers in my practice,” you may say, but, if not homicide, drug-related deaths (3.68 per 100,000 person-years) and suicide (1.42 per 100,000 person-years) together comprise 18% of all maternal deaths. Non-Hispanic White women, Medicaid-insured women, and women residing in smaller cities were especially likely to die from drugs or suicide. More than half (54.3%) of perinatal suicides involve intimate partner conflict, which increases the risk ninefold. Perinatal mood disorders, affecting up to 15% of pregnant and postpartum U.S. women, is also a risk factor in substance abuse, opioid overdose death, and suicide.

And substance use has gotten more dangerous with the increase in fentanyl lacing. Pregnancy-associated deaths (4%-10% of deaths) involving opioids more than doubled between 2007 and 2016, and, although the rates are higher for Black women, the increase has been greater for non-Hispanic White women. Two-thirds of those deaths occur between 6 and 12 months postpartum, on our watch. Although many women decrease substance use during pregnancy, they may fall back into substance use (rates increase 4 times by 7-12 months after delivery) and not continue to receive treatment. Although pharmacotherapy (e.g., methadone, buprenorphine treatment) is the current standard of care for opioid use disorder (OUD) during pregnancy, nearly half receiving treatment in publicly funded centers are not receiving these medications and others may lose insurance or access to pregnancy-related treatment programs after delivery, increasing risk of relapse. Stigma, and punitive or discriminatory approaches to pregnant women with OUD (e.g., jail, removal of children) can dissuade them from participating in treatment, increasing overdose risk.

It is important to note that in more than half of the 41 deaths from violent trauma in one study (including 22 homicides), obstetrical providers knew of or suspected IPV. Also, the vast majority (74%) of those who died by drugs or suicide had made one or more emergency department or hospital visit between their delivery and death, and 39% had made three or more visits. Without knowing if anything was done in those cases, we also know that, in addition to thorough, compassionate providers, there is sometimes segmentation of responsibility, insensitivity, discrimination, racism, stigma, inequity, lack of resources, lack of access, lack of payment mechanisms, legal issues for immigrants, time constraints, and other systemic deficits that may hinder effective care for these and subsequent women.
 

Awareness and action

What should we, who are primary care pediatric providers, do about these threats to the mothers and pregnant young women we care for? Clearly, their children, our main patients, would be terribly and permanently hurt by harm coming to their mothers – the extreme adverse childhood experiences and social determinants of health to which we are already committed.

I hope this article will help alert pediatric providers to what is being published, mainly as women’s health and public health issues.

First, we need awareness of the physical symptoms that may come up in our interactions with pregnant and postpartum women so that we can educate them and expedite any indicated emergency care.

Next, we need to expand our routine screening of mothers and pregnant women from just the most impactful social determinants of health (including depression, substance use, and IPV) to include anxiety, past suicide attempts and current suicidal ideation, and the presence of firearms, early and repeatedly in the first year of the child’s life. Adults and teens are more likely to disclose risk for sensitive issues through questionnaires than through interviews, perhaps even more so when the identified patient is their child rather than themselves. Any screen can have false negatives, so asking directly when risk is suspected is important. The reason for screening could be framed as caring for the caregiver who is the most important person for the child. It could be accompanied by acknowledging that pregnancy and the first year of life can be difficult for mothers and their partners and that we want to support them and connect them to resources, if needed. When substance use disorder is acknowledged, we should prescribe and teach about Narcan for overdose. When there is IPV, we should discuss firearm removal/locking as well as counseling on a personal safety plan.

Working as part of an on-site or virtual team that includes professionals who know about community resources and can coordinate care is essential, in addition to educating about 211 for services and 988 for suicide risk.

Finally, we can advocate and vote for programs, people, and laws that support and safeguard women and families, address substance use, and reduce access to firearms.
 

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

Checking on the well-being of mothers is one of the important acknowledged aspects of primary pediatric care. “How are you doing?” directed to the child’s mother has long been considered an appropriate question. The AAP recommends several checks in the Bright Futures Guidelines, including conducting several formal screens for depression and asking about “getting time alone with your partner” as well as other supports.

But I have recently become aware of new data that changes my ideas about what we pediatricians need to be doing as part of our care for children and their families, especially in the first year: Considering the risks to the mother of dying.

Maternal mortality increased by 26.6% from 2000 to 2014 across the United States such that it is higher now than it was for our own mothers. The U.S. now has the highest rates of maternal mortality among high-income nations, especially for Black, American Indian, or Alaska Native women, those of lower socioeconomic status, and those under 18 or over 35 years old.

You may be thinking, well, that is an issue for ob.gyns. Indeed, the most common reasons for maternal death are cardiovascular: hemorrhage, hypertensive disorders, deep vein thrombosis, and stroke, all usually occurring at or in the first week after birth. You may have heard about sudden unexpected heart failure from postpartum cardiomyopathy, although rare (1 in 1,000-4,000), presenting from 1 month pre birth to 5 months post delivery, which is when we may be the main clinicians seeing the mother, not the ob.gyns. This can be easily missed since it presents with shortness of breath and decreased exercise tolerance, fatigue, palpitations, and/or leg swelling. Serious eclampsia may have only symptoms of headache or abdominal pain. All of these may easily be mistaken for lingering pregnancy symptoms. But in higher income countries, such as the U.S., 38% of maternal deaths occur from 8 to 42 days after birth, the period for fatal infections as well as cardiac complications. Elevated risk for all of these causes of mortality include Black race, obesity, tobacco use, congenital heart disease, and being older than 40.

As pediatric providers, we may see mothers along with their infants as newborns in the hospital, at day 2, at 2 weeks, or even at 1-2 months after birth, potentially before their one recommended postnatal obstetric visit at 3-8 weeks. Asking the mother how she is feeling at those times should not just be a social nicety but rather an additional check for serious postnatal complications.
 

Additional concerns

But wait, it gets worse.

Did you know that the leading cause of maternal death from pregnancy up to 1 year after a birth is homicide?

Maternal perinatal mortality figures have not usually included “perinatal-associated” deaths, a maternal death attributable to a condition that is unaffected by the pregnancy and occurring within 1 year of delivery (that I will cite as perinatal henceforth). While half of maternal deaths occur during pregnancy, another half occur in the year following. There were 3.62 homicides per 100,000 live births among females who were pregnant or within 1 year postpartum, 16% more than for similarly aged nonpregnant and nonpostpartum women (3.12 deaths/100,000 population, P < .05). Homicides made up 8.4% of reported perinatal maternal deaths from all causes, with a rate of 1.7 per 100,000 live births, twice the rate of any one of the other leading causes noted above. Black women had seven times the risk of perinatal homicide as that of White women. Females under 20, many of them our own pediatric patients, had a greater than six times higher risk and those aged 20-24 had a 65% higher risk of pregnancy-associated homicide across race and ethnic groups. Homicide is most likely before 21 weeks of pregnancy, decreases in the third trimester, but increases again after birth. Two-thirds of pregnancy-associated homicide deaths occurred in the home, with the perpetrator a current or prior partner (> 59%, with 98% being male), 45%-50% were associated with reported intimate partner violence (IPV), and the most common method was a firearm (55%). Often the same women had histories of substance abuse, serious mental illness, and/or prior IPV, all risk factors for pregnancy-associated deaths, including from homicide.

Homicide? “Not the mothers in my practice,” you may say, but, if not homicide, drug-related deaths (3.68 per 100,000 person-years) and suicide (1.42 per 100,000 person-years) together comprise 18% of all maternal deaths. Non-Hispanic White women, Medicaid-insured women, and women residing in smaller cities were especially likely to die from drugs or suicide. More than half (54.3%) of perinatal suicides involve intimate partner conflict, which increases the risk ninefold. Perinatal mood disorders, affecting up to 15% of pregnant and postpartum U.S. women, is also a risk factor in substance abuse, opioid overdose death, and suicide.

And substance use has gotten more dangerous with the increase in fentanyl lacing. Pregnancy-associated deaths (4%-10% of deaths) involving opioids more than doubled between 2007 and 2016, and, although the rates are higher for Black women, the increase has been greater for non-Hispanic White women. Two-thirds of those deaths occur between 6 and 12 months postpartum, on our watch. Although many women decrease substance use during pregnancy, they may fall back into substance use (rates increase 4 times by 7-12 months after delivery) and not continue to receive treatment. Although pharmacotherapy (e.g., methadone, buprenorphine treatment) is the current standard of care for opioid use disorder (OUD) during pregnancy, nearly half receiving treatment in publicly funded centers are not receiving these medications and others may lose insurance or access to pregnancy-related treatment programs after delivery, increasing risk of relapse. Stigma, and punitive or discriminatory approaches to pregnant women with OUD (e.g., jail, removal of children) can dissuade them from participating in treatment, increasing overdose risk.

It is important to note that in more than half of the 41 deaths from violent trauma in one study (including 22 homicides), obstetrical providers knew of or suspected IPV. Also, the vast majority (74%) of those who died by drugs or suicide had made one or more emergency department or hospital visit between their delivery and death, and 39% had made three or more visits. Without knowing if anything was done in those cases, we also know that, in addition to thorough, compassionate providers, there is sometimes segmentation of responsibility, insensitivity, discrimination, racism, stigma, inequity, lack of resources, lack of access, lack of payment mechanisms, legal issues for immigrants, time constraints, and other systemic deficits that may hinder effective care for these and subsequent women.
 

Awareness and action

What should we, who are primary care pediatric providers, do about these threats to the mothers and pregnant young women we care for? Clearly, their children, our main patients, would be terribly and permanently hurt by harm coming to their mothers – the extreme adverse childhood experiences and social determinants of health to which we are already committed.

I hope this article will help alert pediatric providers to what is being published, mainly as women’s health and public health issues.

First, we need awareness of the physical symptoms that may come up in our interactions with pregnant and postpartum women so that we can educate them and expedite any indicated emergency care.

Next, we need to expand our routine screening of mothers and pregnant women from just the most impactful social determinants of health (including depression, substance use, and IPV) to include anxiety, past suicide attempts and current suicidal ideation, and the presence of firearms, early and repeatedly in the first year of the child’s life. Adults and teens are more likely to disclose risk for sensitive issues through questionnaires than through interviews, perhaps even more so when the identified patient is their child rather than themselves. Any screen can have false negatives, so asking directly when risk is suspected is important. The reason for screening could be framed as caring for the caregiver who is the most important person for the child. It could be accompanied by acknowledging that pregnancy and the first year of life can be difficult for mothers and their partners and that we want to support them and connect them to resources, if needed. When substance use disorder is acknowledged, we should prescribe and teach about Narcan for overdose. When there is IPV, we should discuss firearm removal/locking as well as counseling on a personal safety plan.

Working as part of an on-site or virtual team that includes professionals who know about community resources and can coordinate care is essential, in addition to educating about 211 for services and 988 for suicide risk.

Finally, we can advocate and vote for programs, people, and laws that support and safeguard women and families, address substance use, and reduce access to firearms.
 

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

Checking on the well-being of mothers is one of the important acknowledged aspects of primary pediatric care. “How are you doing?” directed to the child’s mother has long been considered an appropriate question. The AAP recommends several checks in the Bright Futures Guidelines, including conducting several formal screens for depression and asking about “getting time alone with your partner” as well as other supports.

But I have recently become aware of new data that changes my ideas about what we pediatricians need to be doing as part of our care for children and their families, especially in the first year: Considering the risks to the mother of dying.

Maternal mortality increased by 26.6% from 2000 to 2014 across the United States such that it is higher now than it was for our own mothers. The U.S. now has the highest rates of maternal mortality among high-income nations, especially for Black, American Indian, or Alaska Native women, those of lower socioeconomic status, and those under 18 or over 35 years old.

You may be thinking, well, that is an issue for ob.gyns. Indeed, the most common reasons for maternal death are cardiovascular: hemorrhage, hypertensive disorders, deep vein thrombosis, and stroke, all usually occurring at or in the first week after birth. You may have heard about sudden unexpected heart failure from postpartum cardiomyopathy, although rare (1 in 1,000-4,000), presenting from 1 month pre birth to 5 months post delivery, which is when we may be the main clinicians seeing the mother, not the ob.gyns. This can be easily missed since it presents with shortness of breath and decreased exercise tolerance, fatigue, palpitations, and/or leg swelling. Serious eclampsia may have only symptoms of headache or abdominal pain. All of these may easily be mistaken for lingering pregnancy symptoms. But in higher income countries, such as the U.S., 38% of maternal deaths occur from 8 to 42 days after birth, the period for fatal infections as well as cardiac complications. Elevated risk for all of these causes of mortality include Black race, obesity, tobacco use, congenital heart disease, and being older than 40.

As pediatric providers, we may see mothers along with their infants as newborns in the hospital, at day 2, at 2 weeks, or even at 1-2 months after birth, potentially before their one recommended postnatal obstetric visit at 3-8 weeks. Asking the mother how she is feeling at those times should not just be a social nicety but rather an additional check for serious postnatal complications.
 

Additional concerns

But wait, it gets worse.

Did you know that the leading cause of maternal death from pregnancy up to 1 year after a birth is homicide?

Maternal perinatal mortality figures have not usually included “perinatal-associated” deaths, a maternal death attributable to a condition that is unaffected by the pregnancy and occurring within 1 year of delivery (that I will cite as perinatal henceforth). While half of maternal deaths occur during pregnancy, another half occur in the year following. There were 3.62 homicides per 100,000 live births among females who were pregnant or within 1 year postpartum, 16% more than for similarly aged nonpregnant and nonpostpartum women (3.12 deaths/100,000 population, P < .05). Homicides made up 8.4% of reported perinatal maternal deaths from all causes, with a rate of 1.7 per 100,000 live births, twice the rate of any one of the other leading causes noted above. Black women had seven times the risk of perinatal homicide as that of White women. Females under 20, many of them our own pediatric patients, had a greater than six times higher risk and those aged 20-24 had a 65% higher risk of pregnancy-associated homicide across race and ethnic groups. Homicide is most likely before 21 weeks of pregnancy, decreases in the third trimester, but increases again after birth. Two-thirds of pregnancy-associated homicide deaths occurred in the home, with the perpetrator a current or prior partner (> 59%, with 98% being male), 45%-50% were associated with reported intimate partner violence (IPV), and the most common method was a firearm (55%). Often the same women had histories of substance abuse, serious mental illness, and/or prior IPV, all risk factors for pregnancy-associated deaths, including from homicide.

Homicide? “Not the mothers in my practice,” you may say, but, if not homicide, drug-related deaths (3.68 per 100,000 person-years) and suicide (1.42 per 100,000 person-years) together comprise 18% of all maternal deaths. Non-Hispanic White women, Medicaid-insured women, and women residing in smaller cities were especially likely to die from drugs or suicide. More than half (54.3%) of perinatal suicides involve intimate partner conflict, which increases the risk ninefold. Perinatal mood disorders, affecting up to 15% of pregnant and postpartum U.S. women, is also a risk factor in substance abuse, opioid overdose death, and suicide.

And substance use has gotten more dangerous with the increase in fentanyl lacing. Pregnancy-associated deaths (4%-10% of deaths) involving opioids more than doubled between 2007 and 2016, and, although the rates are higher for Black women, the increase has been greater for non-Hispanic White women. Two-thirds of those deaths occur between 6 and 12 months postpartum, on our watch. Although many women decrease substance use during pregnancy, they may fall back into substance use (rates increase 4 times by 7-12 months after delivery) and not continue to receive treatment. Although pharmacotherapy (e.g., methadone, buprenorphine treatment) is the current standard of care for opioid use disorder (OUD) during pregnancy, nearly half receiving treatment in publicly funded centers are not receiving these medications and others may lose insurance or access to pregnancy-related treatment programs after delivery, increasing risk of relapse. Stigma, and punitive or discriminatory approaches to pregnant women with OUD (e.g., jail, removal of children) can dissuade them from participating in treatment, increasing overdose risk.

It is important to note that in more than half of the 41 deaths from violent trauma in one study (including 22 homicides), obstetrical providers knew of or suspected IPV. Also, the vast majority (74%) of those who died by drugs or suicide had made one or more emergency department or hospital visit between their delivery and death, and 39% had made three or more visits. Without knowing if anything was done in those cases, we also know that, in addition to thorough, compassionate providers, there is sometimes segmentation of responsibility, insensitivity, discrimination, racism, stigma, inequity, lack of resources, lack of access, lack of payment mechanisms, legal issues for immigrants, time constraints, and other systemic deficits that may hinder effective care for these and subsequent women.
 

Awareness and action

What should we, who are primary care pediatric providers, do about these threats to the mothers and pregnant young women we care for? Clearly, their children, our main patients, would be terribly and permanently hurt by harm coming to their mothers – the extreme adverse childhood experiences and social determinants of health to which we are already committed.

I hope this article will help alert pediatric providers to what is being published, mainly as women’s health and public health issues.

First, we need awareness of the physical symptoms that may come up in our interactions with pregnant and postpartum women so that we can educate them and expedite any indicated emergency care.

Next, we need to expand our routine screening of mothers and pregnant women from just the most impactful social determinants of health (including depression, substance use, and IPV) to include anxiety, past suicide attempts and current suicidal ideation, and the presence of firearms, early and repeatedly in the first year of the child’s life. Adults and teens are more likely to disclose risk for sensitive issues through questionnaires than through interviews, perhaps even more so when the identified patient is their child rather than themselves. Any screen can have false negatives, so asking directly when risk is suspected is important. The reason for screening could be framed as caring for the caregiver who is the most important person for the child. It could be accompanied by acknowledging that pregnancy and the first year of life can be difficult for mothers and their partners and that we want to support them and connect them to resources, if needed. When substance use disorder is acknowledged, we should prescribe and teach about Narcan for overdose. When there is IPV, we should discuss firearm removal/locking as well as counseling on a personal safety plan.

Working as part of an on-site or virtual team that includes professionals who know about community resources and can coordinate care is essential, in addition to educating about 211 for services and 988 for suicide risk.

Finally, we can advocate and vote for programs, people, and laws that support and safeguard women and families, address substance use, and reduce access to firearms.
 

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.

The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.

Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.

There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.

Duration of effectiveness in infants was one of the main questions the study sought to answer.

The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
 

Answering the ‘blunting’ question

This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.

Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
 

Best time to give mothers the vaccine

Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”

That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
 

Positive results in the United States

In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.

The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.

That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.

However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.

“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.

The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
 

Uptake low despite positive data

Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”

Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.

As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”

One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.

Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.

The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.

Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.

There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.

Duration of effectiveness in infants was one of the main questions the study sought to answer.

The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
 

Answering the ‘blunting’ question

This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.

Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
 

Best time to give mothers the vaccine

Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”

That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
 

Positive results in the United States

In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.

The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.

That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.

However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.

“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.

The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
 

Uptake low despite positive data

Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”

Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.

As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”

One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.

Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.

The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.

Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.

There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.

Duration of effectiveness in infants was one of the main questions the study sought to answer.

The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
 

Answering the ‘blunting’ question

This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.

Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
 

Best time to give mothers the vaccine

Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”

That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
 

Positive results in the United States

In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.

The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.

That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.

However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.

“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.

The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
 

Uptake low despite positive data

Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”

Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.

As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”

One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.

If you are a pediatrician, babies are your bread and butter. In fact, they are the whole enchilada. Without them you are going to starve. Even if you are an adolescent medicine specialist, the pipeline feeding your business begins with babies. The number of babies entering the conveyor belt that eventually ends up in your office is something that should interest you. It probably doesn’t surprise you to learn that the fertility rate in this country has fallen. In fact, it has now dipped below the “replacement” threshold of 2.1%.

Another number that might interest you is ideal family size. In others words, the number of children American adults consider when they are envisioning the ideal family. You may be surprised to learn that despite the downward dip on the fertility rate during the 2007-2009 recession and the pandemic, a significant number of Americans still believe that the ideal family includes three children. Looking at the broader population, the ideal family is around 2.5 children, which is a number that is up a little from the 1990s but has scarcely changed over the last 5 decades. Obviously, there is a gap between what the population as a whole believes and the reality of how many children the fertile population is producing. And, there is research that suggests that this gap between personal intention and ideal family size is growing. In other words, people may be saying they believe bigger families are a good thing ... if everything is going well in their life.

What is behind this gap and why is it growing? As people are delaying building their families, realities and expectations collide. Some examples? The impact of their student loans is greater than they anticipated. Climate change and news stories focused on political uncertainty can be unsettling. A person may end up marrying someone who doesn’t concur with their view of an ideal family. Fertility problems crop up with advancing age. The first child may have presented more of a challenge both physically, emotionally, and economically than new parents had expected.

If we agree that the fertility rate is an important number for our survival as a profession, can we agree that because of this vested interest we should become involved in helping families widen this growing gap between their view of the ideal family size and the realities of actually producing that family?

Maybe we don’t need to get involved. When the national climate – meteorologically, politically, and economically – improves families will start making more babies. Right now maybe the better option is to adjust our business model to the fluctuations in demand.

On the other hand, we could ask the American Academy of Pediatrics to join with the American Academy of Obstetricians and Gynecologists and hire a big name advertising agency to launch an ad campaign encouraging young and not so young adults to have more children. However, this might appear rather transparent and self-serving.

The best option is probably to continue to do what we are already doing, but try to do it better. If the challenges of having a first child are a major deterrent to having a second child, we should redouble our efforts toward making, if only in retrospect, that first parenting experience rewarding and enjoyable. That could come in the form of speaking out for parental leave, breastfeeding-friendly workplaces, and more affordable daycare. But it could also come in those scores of encounters we have every day in the office where we give solid, realistic, and compassionate advice on breastfeeding, sleep hygiene, and behavior management. If we can make those tough first 6 months of parenting go more smoothly and make the twos seem less terrible, we may see the average family size in our practice grow before our eyes.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

If you are a pediatrician, babies are your bread and butter. In fact, they are the whole enchilada. Without them you are going to starve. Even if you are an adolescent medicine specialist, the pipeline feeding your business begins with babies. The number of babies entering the conveyor belt that eventually ends up in your office is something that should interest you. It probably doesn’t surprise you to learn that the fertility rate in this country has fallen. In fact, it has now dipped below the “replacement” threshold of 2.1%.

Another number that might interest you is ideal family size. In others words, the number of children American adults consider when they are envisioning the ideal family. You may be surprised to learn that despite the downward dip on the fertility rate during the 2007-2009 recession and the pandemic, a significant number of Americans still believe that the ideal family includes three children. Looking at the broader population, the ideal family is around 2.5 children, which is a number that is up a little from the 1990s but has scarcely changed over the last 5 decades. Obviously, there is a gap between what the population as a whole believes and the reality of how many children the fertile population is producing. And, there is research that suggests that this gap between personal intention and ideal family size is growing. In other words, people may be saying they believe bigger families are a good thing ... if everything is going well in their life.

What is behind this gap and why is it growing? As people are delaying building their families, realities and expectations collide. Some examples? The impact of their student loans is greater than they anticipated. Climate change and news stories focused on political uncertainty can be unsettling. A person may end up marrying someone who doesn’t concur with their view of an ideal family. Fertility problems crop up with advancing age. The first child may have presented more of a challenge both physically, emotionally, and economically than new parents had expected.

If we agree that the fertility rate is an important number for our survival as a profession, can we agree that because of this vested interest we should become involved in helping families widen this growing gap between their view of the ideal family size and the realities of actually producing that family?

Maybe we don’t need to get involved. When the national climate – meteorologically, politically, and economically – improves families will start making more babies. Right now maybe the better option is to adjust our business model to the fluctuations in demand.

On the other hand, we could ask the American Academy of Pediatrics to join with the American Academy of Obstetricians and Gynecologists and hire a big name advertising agency to launch an ad campaign encouraging young and not so young adults to have more children. However, this might appear rather transparent and self-serving.

The best option is probably to continue to do what we are already doing, but try to do it better. If the challenges of having a first child are a major deterrent to having a second child, we should redouble our efforts toward making, if only in retrospect, that first parenting experience rewarding and enjoyable. That could come in the form of speaking out for parental leave, breastfeeding-friendly workplaces, and more affordable daycare. But it could also come in those scores of encounters we have every day in the office where we give solid, realistic, and compassionate advice on breastfeeding, sleep hygiene, and behavior management. If we can make those tough first 6 months of parenting go more smoothly and make the twos seem less terrible, we may see the average family size in our practice grow before our eyes.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

If you are a pediatrician, babies are your bread and butter. In fact, they are the whole enchilada. Without them you are going to starve. Even if you are an adolescent medicine specialist, the pipeline feeding your business begins with babies. The number of babies entering the conveyor belt that eventually ends up in your office is something that should interest you. It probably doesn’t surprise you to learn that the fertility rate in this country has fallen. In fact, it has now dipped below the “replacement” threshold of 2.1%.

Another number that might interest you is ideal family size. In others words, the number of children American adults consider when they are envisioning the ideal family. You may be surprised to learn that despite the downward dip on the fertility rate during the 2007-2009 recession and the pandemic, a significant number of Americans still believe that the ideal family includes three children. Looking at the broader population, the ideal family is around 2.5 children, which is a number that is up a little from the 1990s but has scarcely changed over the last 5 decades. Obviously, there is a gap between what the population as a whole believes and the reality of how many children the fertile population is producing. And, there is research that suggests that this gap between personal intention and ideal family size is growing. In other words, people may be saying they believe bigger families are a good thing ... if everything is going well in their life.

What is behind this gap and why is it growing? As people are delaying building their families, realities and expectations collide. Some examples? The impact of their student loans is greater than they anticipated. Climate change and news stories focused on political uncertainty can be unsettling. A person may end up marrying someone who doesn’t concur with their view of an ideal family. Fertility problems crop up with advancing age. The first child may have presented more of a challenge both physically, emotionally, and economically than new parents had expected.

If we agree that the fertility rate is an important number for our survival as a profession, can we agree that because of this vested interest we should become involved in helping families widen this growing gap between their view of the ideal family size and the realities of actually producing that family?

Maybe we don’t need to get involved. When the national climate – meteorologically, politically, and economically – improves families will start making more babies. Right now maybe the better option is to adjust our business model to the fluctuations in demand.

On the other hand, we could ask the American Academy of Pediatrics to join with the American Academy of Obstetricians and Gynecologists and hire a big name advertising agency to launch an ad campaign encouraging young and not so young adults to have more children. However, this might appear rather transparent and self-serving.

The best option is probably to continue to do what we are already doing, but try to do it better. If the challenges of having a first child are a major deterrent to having a second child, we should redouble our efforts toward making, if only in retrospect, that first parenting experience rewarding and enjoyable. That could come in the form of speaking out for parental leave, breastfeeding-friendly workplaces, and more affordable daycare. But it could also come in those scores of encounters we have every day in the office where we give solid, realistic, and compassionate advice on breastfeeding, sleep hygiene, and behavior management. If we can make those tough first 6 months of parenting go more smoothly and make the twos seem less terrible, we may see the average family size in our practice grow before our eyes.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.

The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.

PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.

“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.

Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.

Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.

Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
 

Possible confounders

“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.

Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.

Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.

“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.

Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.

The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.

PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.

“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.

Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.

Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.

Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
 

Possible confounders

“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.

Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.

Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.

“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.

Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.

The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.

PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.

“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.

Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.

Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.

Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
 

Possible confounders

“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.

Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.

Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.

“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.

Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.

Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).

Dr. Amos Grunebaum

“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.

But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.

“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”

Propagating ‘race-based medicine’

Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.

“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”

Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”

In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.

Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.

Dr. Sara E. Edwards

“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.

And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.

Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.

But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.

In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.

“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
 

Bias ‘creeping in’ to neonatal care

Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.

Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.

“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.

This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.

Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.

The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
 

New scoring system needed

Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.

Emma Gillette

“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”

That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”

Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.

In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”

Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.

In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.

Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).

Dr. Amos Grunebaum

“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.

But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.

“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”

Propagating ‘race-based medicine’

Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.

“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”

Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”

In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.

Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.

Dr. Sara E. Edwards

“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.

And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.

Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.

But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.

In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.

“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
 

Bias ‘creeping in’ to neonatal care

Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.

Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.

“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.

This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.

Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.

The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
 

New scoring system needed

Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.

Emma Gillette

“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”

That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”

Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.

In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”

Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.

In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.

Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).

Dr. Amos Grunebaum

“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.

But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.

“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”

Propagating ‘race-based medicine’

Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.

“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”

Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”

In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.

Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.

Dr. Sara E. Edwards

“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.

And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.

Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.

But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.

In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.

“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
 

Bias ‘creeping in’ to neonatal care

Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.

Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.

“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.

This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.

Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.

The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
 

New scoring system needed

Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.

Emma Gillette

“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”

That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”

Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.

In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”

Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.

More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 38^4/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 38^4/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 38^4/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Vaginal microbiota transfer may facilitate normal neurodevelopment for infants born via cesarean delivery, based on data from a new pilot study of 68 infants.

Previous studies have shown that gut microbiota in infancy could affect neurodevelopment, and infants delivered by cesarean are not exposed to potentially helpful microbes acquired by infants during vaginal delivery, wrote Lepeng Zhou, MD, of Southern Medical University, Guangdong, China, and colleagues.

“Infants delivered by C-section start life with very different bacteria than those born vaginally,” corresponding author Jose Clemente, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Because this is the first time the newborn is exposed to microbes, we and others have hypothesized for some time that this ‘first encounter’ might be significant to shape the development of the baby,” he said.

“A few years ago, we demonstrated that it is possible to change the microbiome of C-section–delivered infants using an intervention that makes their microbiome more similar to that of a vaginally-delivered infant,” Dr. Clemente told this news organization. “In this study just published, we show that this procedure not only changes the microbiome of C-section infants, but it also modifies a health outcome (in this case, neurodevelopment). This is highly significant because it opens the way to reduce the risk that C-section infants have for certain conditions through a very simple microbial intervention,” he said.
 

‘Significantly higher’ ASQ-3 scores

In the current study, published in Cell Host & Microbe, the researchers examined the impact of vaginal microbiota transfer (VMT) on the neurodevelopment of cesarean-delivered infants. They randomized 35 women scheduled for cesarean delivery with a single infant to VMT and 41 to a control intervention of saline gauze for their infants immediately after delivery.

The primary outcome of infant neurodevelopment was assessed using the Ages and Stages Questionnaire (ASQ-3) score at 6 months. The researchers also collected fecal samples and assessed safety outcomes for the infants at 3, 7, 30, and 42 days after birth. The final analysis comprised 32 infants in the VMT group and 36 in the control group. The mean age of the mothers was 32 years; the mean gestational age of the infants was 39 weeks, but the difference was significant and slightly less in the VMT group compared with the controls (38.38 weeks vs. 39.13 weeks, P = .007). A group of 33 vaginally-delivered infants (VD) underwent ASQ-3 testing to serve as a reference group.

At 6 months, ASQ-3 scores were significantly higher (10.09%, P = .014) with VMT compared with controls, and the difference remained significant after adjustment for multiple factors including gestational age.

ASQ-3 total scores at 6 months were not significantly different between the VMT group and the VD reference group (mean difference of 8.84 VMT to VD, P = .346); scores between these groups also were similar at 3 months (mean difference of –1.48 VMT to VD, P = .900) and no significant differences appeared in ASQ-3 subdomains between these groups at either time period.

An examination of gut metabolites in stool showed significant differences in fecal metabolites and metabolic function, signs of gut microbiota maturation, the researchers noted.

“Interestingly, all the genera and metabolites that exhibited positive correlations with neurodevelopmental scores were upregulated in the VMT group, whereas the only negative correlation of Klebsiella was downregulated, indicating that VMT may impact neurodevelopment through the modulation of specific gut microbial genera and metabolites,” the researchers wrote.

No serious adverse events occurred in either group during the study period. Nine adverse events were reported; 4 in the VMT group and 5 in the control group. The most common AEs were mild skin disorders, including papules, pustules, and erythema.

The findings were limited by several factors including the potential for transfer not only of vaginal microbiota, but also vaginal metabolites, mycobiome, and virome, which blurs the potential mechanism of VMT, the researchers noted. Other limitations were the relatively short study period, small sample size, and cervical HPV screening within the past 5 years, not during pregnancy, they wrote.

However, the results suggest that VMT is safe, and may help improve the fecal microbiome in cesarean-delivered infants, and the long-term effects merit further studies in larger populations, they concluded.
 

Limitations and outlook

Dr. Clemente said in an interview that the researchers were “hopeful that the study would demonstrate a health benefit, as it does with some limitations.” The current study findings confirm some previous results showing that modification of the microbiomes of C-section infants is possible through a transfer of maternal vaginal microbes, he said.

“There is also an important aspect that was confirmed here: The lack of serious adverse events associated with the procedure, and the fact that transferring vaginal microbes did not increase the risk of adverse events compared to the control group or to vaginally-delivered infants. This is fundamental to establish that using rigorous exclusion criteria we can perform this procedure safely for infants and mothers,” he added.

“We are at very early stages yet to talk about clinical implications,” said Dr. Clemente. “This is one of the first studies to demonstrate a benefit to the transfer of microbes from mothers to infants, and as such it opens the way for future trials that confirm these findings. The clinical application is still in the future, but this is an important first step towards that goal.”

Interest in restoring gut microbiota to potentially benefit infants persists, but a recent study published in Frontiers and Cellular and Infection Microbiology contradicted the potential association between maternal vaginal microbiome and an infant’s gut microbiome based on an analysis of infant stool.

“There are many reasons why different studies might reach different conclusions: The experimental procedures, the analytical methods, the cohort under study,” Dr. Clemente said when asked to comment on the Frontiers study. “Further studies are needed to establish whether this procedure is equally effective under all conditions and whether health benefits are generalizable or specific to particular populations.”

Several research gaps remain, Dr. Clemente said. “First, neurodevelopment was measured through a questionnaire that captures various aspects such as communication, motor skills, or problem solving. While this is a standard way to establish that an infant is in the correct neurodevelopmental pathway, it is not a ‘hard’ measure of cellular or biochemical processes being impacted by the intervention. Some of our results suggest that there is a change in the metabolome of this infants, particularly an enrichment in GABA, a neurotransmitter, but the exact mechanisms by which the intervention is resulting in a health benefit still remains to be explored,” he said.

“We have an ongoing study here at Mount Sinai to test whether this microbial intervention can be effective in lowering the risk of developing food allergies in newborns who are at high risk, so that is another important future question: What other conditions could benefit from this approach,” said Dr. Clemente.

A third research goal, he added, is “determining what microbes precisely are responsible for the health benefits; this study uses a full microbial community to colonize infants. We show that this is effective and, importantly, that there were no significant adverse events in the treated infants,” he noted. “However, identifying what specific microbes are beneficial would further lower the risk of any potential side effects, while facilitating the development of drugs based on defined microbial consortia,” he said.
 

Safety and efficacy support further studies

“It is widely accepted that the gut microbiome of neonates varies based on mode of delivery,” Anna K. Knight, PhD, assistant professor of gynecology and obstetrics at Emory University, Atlanta, said in an interview.

“C-sections have been associated with increased risk of asthma and metabolic disease, and have been associated with differences in the development of the immune system,” said Dr. Knight, who was not involved in the study. “There have been small pilot studies examining the use of vaginal microbiome transplants to shift the gut microbiome of neonates born by C-section to be more like the gut microbiome of neonates born via vaginal delivery, but the safety and efficacy of this treatment has not been well established. This study examines both, while also evaluating potential changes in the metabolome and neurodevelopmental trajectories.”

The current study confirmed the impact of the neonatal gut microbe on neurodevelopmental outcomes during a sensitive period, said Dr. Knight. “The fact that these differences persisted at 6 months suggests that even if the microbiome composition between vaginally-delivered and preterm infants converged at 1-2 years old, there may be lasting impacts of mode of delivery,” she said.

“The results of this study suggest that vaginal microbiome transplant may be a safe and effective way to mitigate the negative impacts of C-section delivery on the neonatal gut microbiome, and may be protective for neurodevelopment,” she added.

Regarding the Frontiers in Medicine study, Dr. Knight noted that it examined a very different population, with Zhou and colleagues focusing on Chinese infants, while Dos Santos and colleagues focused on Canadian infants.

“There was also a substantial difference in sample size between the two studies, with Dos Santos and colleagues examining > 500 more infants,” she said. “Additionally, the two studies differed in the sequencing technology used, sample collection methods, and antibiotic exposure, which can all impact microbiome study results.”

Since the current study showed efficacy and safety of VMT in a small clinical trial, larger trials with more diverse participants are needed to further examine the impact of VMT, said Dr. Knight. “The risks of vaginal microbiome transplant in mothers with infections should also be considered, and the mechanisms by which the neonatal gut microbiome impacts neurodevelopment need further investigation,” she said.

The study was funded by the National Key R&D Program of China, the Canadian Institute of Health Research, the National Natural Science Foundation of China, the Clinical Research Startup Program of Southern Medical University, China, and the Top Talent Program of Foshan Women and Children Hospital, China. The researchers and Dr. Knight had no financial conflicts to disclose.

Vaginal microbiota transfer may facilitate normal neurodevelopment for infants born via cesarean delivery, based on data from a new pilot study of 68 infants.

Previous studies have shown that gut microbiota in infancy could affect neurodevelopment, and infants delivered by cesarean are not exposed to potentially helpful microbes acquired by infants during vaginal delivery, wrote Lepeng Zhou, MD, of Southern Medical University, Guangdong, China, and colleagues.

“Infants delivered by C-section start life with very different bacteria than those born vaginally,” corresponding author Jose Clemente, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Because this is the first time the newborn is exposed to microbes, we and others have hypothesized for some time that this ‘first encounter’ might be significant to shape the development of the baby,” he said.

“A few years ago, we demonstrated that it is possible to change the microbiome of C-section–delivered infants using an intervention that makes their microbiome more similar to that of a vaginally-delivered infant,” Dr. Clemente told this news organization. “In this study just published, we show that this procedure not only changes the microbiome of C-section infants, but it also modifies a health outcome (in this case, neurodevelopment). This is highly significant because it opens the way to reduce the risk that C-section infants have for certain conditions through a very simple microbial intervention,” he said.
 

‘Significantly higher’ ASQ-3 scores

In the current study, published in Cell Host & Microbe, the researchers examined the impact of vaginal microbiota transfer (VMT) on the neurodevelopment of cesarean-delivered infants. They randomized 35 women scheduled for cesarean delivery with a single infant to VMT and 41 to a control intervention of saline gauze for their infants immediately after delivery.

The primary outcome of infant neurodevelopment was assessed using the Ages and Stages Questionnaire (ASQ-3) score at 6 months. The researchers also collected fecal samples and assessed safety outcomes for the infants at 3, 7, 30, and 42 days after birth. The final analysis comprised 32 infants in the VMT group and 36 in the control group. The mean age of the mothers was 32 years; the mean gestational age of the infants was 39 weeks, but the difference was significant and slightly less in the VMT group compared with the controls (38.38 weeks vs. 39.13 weeks, P = .007). A group of 33 vaginally-delivered infants (VD) underwent ASQ-3 testing to serve as a reference group.

At 6 months, ASQ-3 scores were significantly higher (10.09%, P = .014) with VMT compared with controls, and the difference remained significant after adjustment for multiple factors including gestational age.

ASQ-3 total scores at 6 months were not significantly different between the VMT group and the VD reference group (mean difference of 8.84 VMT to VD, P = .346); scores between these groups also were similar at 3 months (mean difference of –1.48 VMT to VD, P = .900) and no significant differences appeared in ASQ-3 subdomains between these groups at either time period.

An examination of gut metabolites in stool showed significant differences in fecal metabolites and metabolic function, signs of gut microbiota maturation, the researchers noted.

“Interestingly, all the genera and metabolites that exhibited positive correlations with neurodevelopmental scores were upregulated in the VMT group, whereas the only negative correlation of Klebsiella was downregulated, indicating that VMT may impact neurodevelopment through the modulation of specific gut microbial genera and metabolites,” the researchers wrote.

No serious adverse events occurred in either group during the study period. Nine adverse events were reported; 4 in the VMT group and 5 in the control group. The most common AEs were mild skin disorders, including papules, pustules, and erythema.

The findings were limited by several factors including the potential for transfer not only of vaginal microbiota, but also vaginal metabolites, mycobiome, and virome, which blurs the potential mechanism of VMT, the researchers noted. Other limitations were the relatively short study period, small sample size, and cervical HPV screening within the past 5 years, not during pregnancy, they wrote.

However, the results suggest that VMT is safe, and may help improve the fecal microbiome in cesarean-delivered infants, and the long-term effects merit further studies in larger populations, they concluded.
 

Limitations and outlook

Dr. Clemente said in an interview that the researchers were “hopeful that the study would demonstrate a health benefit, as it does with some limitations.” The current study findings confirm some previous results showing that modification of the microbiomes of C-section infants is possible through a transfer of maternal vaginal microbes, he said.

“There is also an important aspect that was confirmed here: The lack of serious adverse events associated with the procedure, and the fact that transferring vaginal microbes did not increase the risk of adverse events compared to the control group or to vaginally-delivered infants. This is fundamental to establish that using rigorous exclusion criteria we can perform this procedure safely for infants and mothers,” he added.

“We are at very early stages yet to talk about clinical implications,” said Dr. Clemente. “This is one of the first studies to demonstrate a benefit to the transfer of microbes from mothers to infants, and as such it opens the way for future trials that confirm these findings. The clinical application is still in the future, but this is an important first step towards that goal.”

Interest in restoring gut microbiota to potentially benefit infants persists, but a recent study published in Frontiers and Cellular and Infection Microbiology contradicted the potential association between maternal vaginal microbiome and an infant’s gut microbiome based on an analysis of infant stool.

“There are many reasons why different studies might reach different conclusions: The experimental procedures, the analytical methods, the cohort under study,” Dr. Clemente said when asked to comment on the Frontiers study. “Further studies are needed to establish whether this procedure is equally effective under all conditions and whether health benefits are generalizable or specific to particular populations.”

Several research gaps remain, Dr. Clemente said. “First, neurodevelopment was measured through a questionnaire that captures various aspects such as communication, motor skills, or problem solving. While this is a standard way to establish that an infant is in the correct neurodevelopmental pathway, it is not a ‘hard’ measure of cellular or biochemical processes being impacted by the intervention. Some of our results suggest that there is a change in the metabolome of this infants, particularly an enrichment in GABA, a neurotransmitter, but the exact mechanisms by which the intervention is resulting in a health benefit still remains to be explored,” he said.

“We have an ongoing study here at Mount Sinai to test whether this microbial intervention can be effective in lowering the risk of developing food allergies in newborns who are at high risk, so that is another important future question: What other conditions could benefit from this approach,” said Dr. Clemente.

A third research goal, he added, is “determining what microbes precisely are responsible for the health benefits; this study uses a full microbial community to colonize infants. We show that this is effective and, importantly, that there were no significant adverse events in the treated infants,” he noted. “However, identifying what specific microbes are beneficial would further lower the risk of any potential side effects, while facilitating the development of drugs based on defined microbial consortia,” he said.
 

Safety and efficacy support further studies

“It is widely accepted that the gut microbiome of neonates varies based on mode of delivery,” Anna K. Knight, PhD, assistant professor of gynecology and obstetrics at Emory University, Atlanta, said in an interview.

“C-sections have been associated with increased risk of asthma and metabolic disease, and have been associated with differences in the development of the immune system,” said Dr. Knight, who was not involved in the study. “There have been small pilot studies examining the use of vaginal microbiome transplants to shift the gut microbiome of neonates born by C-section to be more like the gut microbiome of neonates born via vaginal delivery, but the safety and efficacy of this treatment has not been well established. This study examines both, while also evaluating potential changes in the metabolome and neurodevelopmental trajectories.”

The current study confirmed the impact of the neonatal gut microbe on neurodevelopmental outcomes during a sensitive period, said Dr. Knight. “The fact that these differences persisted at 6 months suggests that even if the microbiome composition between vaginally-delivered and preterm infants converged at 1-2 years old, there may be lasting impacts of mode of delivery,” she said.

“The results of this study suggest that vaginal microbiome transplant may be a safe and effective way to mitigate the negative impacts of C-section delivery on the neonatal gut microbiome, and may be protective for neurodevelopment,” she added.

Regarding the Frontiers in Medicine study, Dr. Knight noted that it examined a very different population, with Zhou and colleagues focusing on Chinese infants, while Dos Santos and colleagues focused on Canadian infants.

“There was also a substantial difference in sample size between the two studies, with Dos Santos and colleagues examining > 500 more infants,” she said. “Additionally, the two studies differed in the sequencing technology used, sample collection methods, and antibiotic exposure, which can all impact microbiome study results.”

Since the current study showed efficacy and safety of VMT in a small clinical trial, larger trials with more diverse participants are needed to further examine the impact of VMT, said Dr. Knight. “The risks of vaginal microbiome transplant in mothers with infections should also be considered, and the mechanisms by which the neonatal gut microbiome impacts neurodevelopment need further investigation,” she said.

The study was funded by the National Key R&D Program of China, the Canadian Institute of Health Research, the National Natural Science Foundation of China, the Clinical Research Startup Program of Southern Medical University, China, and the Top Talent Program of Foshan Women and Children Hospital, China. The researchers and Dr. Knight had no financial conflicts to disclose.

Vaginal microbiota transfer may facilitate normal neurodevelopment for infants born via cesarean delivery, based on data from a new pilot study of 68 infants.

Previous studies have shown that gut microbiota in infancy could affect neurodevelopment, and infants delivered by cesarean are not exposed to potentially helpful microbes acquired by infants during vaginal delivery, wrote Lepeng Zhou, MD, of Southern Medical University, Guangdong, China, and colleagues.

“Infants delivered by C-section start life with very different bacteria than those born vaginally,” corresponding author Jose Clemente, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Because this is the first time the newborn is exposed to microbes, we and others have hypothesized for some time that this ‘first encounter’ might be significant to shape the development of the baby,” he said.

“A few years ago, we demonstrated that it is possible to change the microbiome of C-section–delivered infants using an intervention that makes their microbiome more similar to that of a vaginally-delivered infant,” Dr. Clemente told this news organization. “In this study just published, we show that this procedure not only changes the microbiome of C-section infants, but it also modifies a health outcome (in this case, neurodevelopment). This is highly significant because it opens the way to reduce the risk that C-section infants have for certain conditions through a very simple microbial intervention,” he said.
 

‘Significantly higher’ ASQ-3 scores

In the current study, published in Cell Host & Microbe, the researchers examined the impact of vaginal microbiota transfer (VMT) on the neurodevelopment of cesarean-delivered infants. They randomized 35 women scheduled for cesarean delivery with a single infant to VMT and 41 to a control intervention of saline gauze for their infants immediately after delivery.

The primary outcome of infant neurodevelopment was assessed using the Ages and Stages Questionnaire (ASQ-3) score at 6 months. The researchers also collected fecal samples and assessed safety outcomes for the infants at 3, 7, 30, and 42 days after birth. The final analysis comprised 32 infants in the VMT group and 36 in the control group. The mean age of the mothers was 32 years; the mean gestational age of the infants was 39 weeks, but the difference was significant and slightly less in the VMT group compared with the controls (38.38 weeks vs. 39.13 weeks, P = .007). A group of 33 vaginally-delivered infants (VD) underwent ASQ-3 testing to serve as a reference group.

At 6 months, ASQ-3 scores were significantly higher (10.09%, P = .014) with VMT compared with controls, and the difference remained significant after adjustment for multiple factors including gestational age.

ASQ-3 total scores at 6 months were not significantly different between the VMT group and the VD reference group (mean difference of 8.84 VMT to VD, P = .346); scores between these groups also were similar at 3 months (mean difference of –1.48 VMT to VD, P = .900) and no significant differences appeared in ASQ-3 subdomains between these groups at either time period.

An examination of gut metabolites in stool showed significant differences in fecal metabolites and metabolic function, signs of gut microbiota maturation, the researchers noted.

“Interestingly, all the genera and metabolites that exhibited positive correlations with neurodevelopmental scores were upregulated in the VMT group, whereas the only negative correlation of Klebsiella was downregulated, indicating that VMT may impact neurodevelopment through the modulation of specific gut microbial genera and metabolites,” the researchers wrote.

No serious adverse events occurred in either group during the study period. Nine adverse events were reported; 4 in the VMT group and 5 in the control group. The most common AEs were mild skin disorders, including papules, pustules, and erythema.

The findings were limited by several factors including the potential for transfer not only of vaginal microbiota, but also vaginal metabolites, mycobiome, and virome, which blurs the potential mechanism of VMT, the researchers noted. Other limitations were the relatively short study period, small sample size, and cervical HPV screening within the past 5 years, not during pregnancy, they wrote.

However, the results suggest that VMT is safe, and may help improve the fecal microbiome in cesarean-delivered infants, and the long-term effects merit further studies in larger populations, they concluded.
 

Limitations and outlook

Dr. Clemente said in an interview that the researchers were “hopeful that the study would demonstrate a health benefit, as it does with some limitations.” The current study findings confirm some previous results showing that modification of the microbiomes of C-section infants is possible through a transfer of maternal vaginal microbes, he said.

“There is also an important aspect that was confirmed here: The lack of serious adverse events associated with the procedure, and the fact that transferring vaginal microbes did not increase the risk of adverse events compared to the control group or to vaginally-delivered infants. This is fundamental to establish that using rigorous exclusion criteria we can perform this procedure safely for infants and mothers,” he added.

“We are at very early stages yet to talk about clinical implications,” said Dr. Clemente. “This is one of the first studies to demonstrate a benefit to the transfer of microbes from mothers to infants, and as such it opens the way for future trials that confirm these findings. The clinical application is still in the future, but this is an important first step towards that goal.”

Interest in restoring gut microbiota to potentially benefit infants persists, but a recent study published in Frontiers and Cellular and Infection Microbiology contradicted the potential association between maternal vaginal microbiome and an infant’s gut microbiome based on an analysis of infant stool.

“There are many reasons why different studies might reach different conclusions: The experimental procedures, the analytical methods, the cohort under study,” Dr. Clemente said when asked to comment on the Frontiers study. “Further studies are needed to establish whether this procedure is equally effective under all conditions and whether health benefits are generalizable or specific to particular populations.”

Several research gaps remain, Dr. Clemente said. “First, neurodevelopment was measured through a questionnaire that captures various aspects such as communication, motor skills, or problem solving. While this is a standard way to establish that an infant is in the correct neurodevelopmental pathway, it is not a ‘hard’ measure of cellular or biochemical processes being impacted by the intervention. Some of our results suggest that there is a change in the metabolome of this infants, particularly an enrichment in GABA, a neurotransmitter, but the exact mechanisms by which the intervention is resulting in a health benefit still remains to be explored,” he said.

“We have an ongoing study here at Mount Sinai to test whether this microbial intervention can be effective in lowering the risk of developing food allergies in newborns who are at high risk, so that is another important future question: What other conditions could benefit from this approach,” said Dr. Clemente.

A third research goal, he added, is “determining what microbes precisely are responsible for the health benefits; this study uses a full microbial community to colonize infants. We show that this is effective and, importantly, that there were no significant adverse events in the treated infants,” he noted. “However, identifying what specific microbes are beneficial would further lower the risk of any potential side effects, while facilitating the development of drugs based on defined microbial consortia,” he said.
 

Safety and efficacy support further studies

“It is widely accepted that the gut microbiome of neonates varies based on mode of delivery,” Anna K. Knight, PhD, assistant professor of gynecology and obstetrics at Emory University, Atlanta, said in an interview.

“C-sections have been associated with increased risk of asthma and metabolic disease, and have been associated with differences in the development of the immune system,” said Dr. Knight, who was not involved in the study. “There have been small pilot studies examining the use of vaginal microbiome transplants to shift the gut microbiome of neonates born by C-section to be more like the gut microbiome of neonates born via vaginal delivery, but the safety and efficacy of this treatment has not been well established. This study examines both, while also evaluating potential changes in the metabolome and neurodevelopmental trajectories.”

The current study confirmed the impact of the neonatal gut microbe on neurodevelopmental outcomes during a sensitive period, said Dr. Knight. “The fact that these differences persisted at 6 months suggests that even if the microbiome composition between vaginally-delivered and preterm infants converged at 1-2 years old, there may be lasting impacts of mode of delivery,” she said.

“The results of this study suggest that vaginal microbiome transplant may be a safe and effective way to mitigate the negative impacts of C-section delivery on the neonatal gut microbiome, and may be protective for neurodevelopment,” she added.

Regarding the Frontiers in Medicine study, Dr. Knight noted that it examined a very different population, with Zhou and colleagues focusing on Chinese infants, while Dos Santos and colleagues focused on Canadian infants.

“There was also a substantial difference in sample size between the two studies, with Dos Santos and colleagues examining > 500 more infants,” she said. “Additionally, the two studies differed in the sequencing technology used, sample collection methods, and antibiotic exposure, which can all impact microbiome study results.”

Since the current study showed efficacy and safety of VMT in a small clinical trial, larger trials with more diverse participants are needed to further examine the impact of VMT, said Dr. Knight. “The risks of vaginal microbiome transplant in mothers with infections should also be considered, and the mechanisms by which the neonatal gut microbiome impacts neurodevelopment need further investigation,” she said.

The study was funded by the National Key R&D Program of China, the Canadian Institute of Health Research, the National Natural Science Foundation of China, the Clinical Research Startup Program of Southern Medical University, China, and the Top Talent Program of Foshan Women and Children Hospital, China. The researchers and Dr. Knight had no financial conflicts to disclose.

Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.

The results suggest that including fathers in conversations about breastfeeding and infant sleep practices could help improve adherence, the researchers said.

“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
 

Population-based survey results

Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.

In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).

Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.

Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).

The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.

“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
 

Educational efforts should recognize father’s contributions

In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”

The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.

While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”

To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.

“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.

While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”

Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.

Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.

It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.

“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.

In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.

This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.

Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.

The results suggest that including fathers in conversations about breastfeeding and infant sleep practices could help improve adherence, the researchers said.

“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
 

Population-based survey results

Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.

In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).

Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.

Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).

The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.

“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
 

Educational efforts should recognize father’s contributions

In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”

The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.

While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”

To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.

“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.

While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”

Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.

Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.

It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.

“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.

In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.

This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.

Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.

The results suggest that including fathers in conversations about breastfeeding and infant sleep practices could help improve adherence, the researchers said.

“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
 

Population-based survey results

Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.

In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).

Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.

Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).

The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.

“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
 

Educational efforts should recognize father’s contributions

In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”

The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.

While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”

To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.

“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.

While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”

Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.

Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.

It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.

“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.

In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.

This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.

Kangaroo mother care (KMC), with close skin-to-skin contact between mothers and their low-birthweight newborns, appears to reduce mortality risk by almost one-third, compared with conventional care, according to new research published online in BMJ Global Health.

Starting the contact, which involves mothers carrying the newborn in a sling, within 24 hours of birth and continuing it for at least 8 hours a day both appear to amplify the effect on reducing mortality and infection, the paper states.

Sindhu Sivanandan, MD, with the department of neonatology at Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, and Mari Jeeva Sankar, MD, in the pediatrics department of the All India Institute of Medical Sciences, New Delhi, looked at existing studies to compare KMC with conventional care and to compare starting the intervention within 24 hours of birth versus a later start.

Mortality risk reduction

Analysis showed that, compared with conventional care, KMC appeared to cut mortality risk by 32% (relative risk, 0.68; 95% confidence interval, 0.53-0.86) during birth hospitalization or by 28 days after birth, while it seemed to reduce the risk of severe infection, such as sepsis, by 15% (RR, 0.85; 95% CI, 0.76-0.96; low-certainty evidence.)

That mortality-risk reduction was found regardless of gestational age or weight of the child at enrolment, time of starting KMC, and whether the intervention was started in a hospital or community.

The studies that had compared early with late-initiated KMC showed a reduction in neonatal mortality of 33%.

Low- and middle-income countries have the highest rates of premature births (gestational age of less than 37 weeks) and low birthweight (less than 2,500 grams). Premature births and low birthweight both are key causes of death and disability.

The World Health Organization recommends KMC as the standard of care among low birthweight infants after clinical stabilization. The American Academy of Pediatrics also promotes immediate KMC.
 

Relevance in the U.S.

Grace Chan, MD, MPH, PhD, an epidemiologist and pediatrician with the Harvard School of Public Health, Boston, said though the practice is promoted by the WHO and AAP, recommendations to families vary widely by providers.

She said the health benefits for KMC are numerous. One of the biggest is that skin-to-skin contact can help transfer heat to newborns who may have trouble regulating their own temperature. That is especially important in cold climates in places where there may be insufficient indoor heat.

She said it’s well-known that preterm babies are at higher risk for apnea, and listening to a mother’s heartbeat may stimulate the child to breathe regularly.

Additionally with KMC, there’s an inherent benefit of a mother or caregiver being able to see any change in a newborn’s color immediately when the baby is held so closely, as opposed to a nurse watching several babies at a time in a neonatal intensive care unit.

This is evidence that starting KMC right away is important, because the risk of death for premature and low-weight newborns is highest in the first 24 hours of life, Dr. Chan noted.
 

Barriers of time

There are some barriers, she noted, in that mothers or other caregivers caring for several young children may not have the time to carry a child in a sling for 8 or more hours at a time.

The authors conclude that their findings have policy implications, particularly for low- and middle-income countries: “KMC should be provided to all low birth weight and preterm infants irrespective of the settings – both health facilities and at home,” they wrote.

The authors caution that, “very low birth weight, extremely preterm neonates, and severely unstable neonates were often excluded from studies. More evidence is needed before extrapolating the study results in these high-risk groups.”

The study authors and Dr. Chan report no relevant financial relationships.

Kangaroo mother care (KMC), with close skin-to-skin contact between mothers and their low-birthweight newborns, appears to reduce mortality risk by almost one-third, compared with conventional care, according to new research published online in BMJ Global Health.

Starting the contact, which involves mothers carrying the newborn in a sling, within 24 hours of birth and continuing it for at least 8 hours a day both appear to amplify the effect on reducing mortality and infection, the paper states.

Sindhu Sivanandan, MD, with the department of neonatology at Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, and Mari Jeeva Sankar, MD, in the pediatrics department of the All India Institute of Medical Sciences, New Delhi, looked at existing studies to compare KMC with conventional care and to compare starting the intervention within 24 hours of birth versus a later start.

Mortality risk reduction

Analysis showed that, compared with conventional care, KMC appeared to cut mortality risk by 32% (relative risk, 0.68; 95% confidence interval, 0.53-0.86) during birth hospitalization or by 28 days after birth, while it seemed to reduce the risk of severe infection, such as sepsis, by 15% (RR, 0.85; 95% CI, 0.76-0.96; low-certainty evidence.)

That mortality-risk reduction was found regardless of gestational age or weight of the child at enrolment, time of starting KMC, and whether the intervention was started in a hospital or community.

The studies that had compared early with late-initiated KMC showed a reduction in neonatal mortality of 33%.

Low- and middle-income countries have the highest rates of premature births (gestational age of less than 37 weeks) and low birthweight (less than 2,500 grams). Premature births and low birthweight both are key causes of death and disability.

The World Health Organization recommends KMC as the standard of care among low birthweight infants after clinical stabilization. The American Academy of Pediatrics also promotes immediate KMC.
 

Relevance in the U.S.

Grace Chan, MD, MPH, PhD, an epidemiologist and pediatrician with the Harvard School of Public Health, Boston, said though the practice is promoted by the WHO and AAP, recommendations to families vary widely by providers.

She said the health benefits for KMC are numerous. One of the biggest is that skin-to-skin contact can help transfer heat to newborns who may have trouble regulating their own temperature. That is especially important in cold climates in places where there may be insufficient indoor heat.

She said it’s well-known that preterm babies are at higher risk for apnea, and listening to a mother’s heartbeat may stimulate the child to breathe regularly.

Additionally with KMC, there’s an inherent benefit of a mother or caregiver being able to see any change in a newborn’s color immediately when the baby is held so closely, as opposed to a nurse watching several babies at a time in a neonatal intensive care unit.

This is evidence that starting KMC right away is important, because the risk of death for premature and low-weight newborns is highest in the first 24 hours of life, Dr. Chan noted.
 

Barriers of time

There are some barriers, she noted, in that mothers or other caregivers caring for several young children may not have the time to carry a child in a sling for 8 or more hours at a time.

The authors conclude that their findings have policy implications, particularly for low- and middle-income countries: “KMC should be provided to all low birth weight and preterm infants irrespective of the settings – both health facilities and at home,” they wrote.

The authors caution that, “very low birth weight, extremely preterm neonates, and severely unstable neonates were often excluded from studies. More evidence is needed before extrapolating the study results in these high-risk groups.”

The study authors and Dr. Chan report no relevant financial relationships.

Kangaroo mother care (KMC), with close skin-to-skin contact between mothers and their low-birthweight newborns, appears to reduce mortality risk by almost one-third, compared with conventional care, according to new research published online in BMJ Global Health.

Starting the contact, which involves mothers carrying the newborn in a sling, within 24 hours of birth and continuing it for at least 8 hours a day both appear to amplify the effect on reducing mortality and infection, the paper states.

Sindhu Sivanandan, MD, with the department of neonatology at Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, and Mari Jeeva Sankar, MD, in the pediatrics department of the All India Institute of Medical Sciences, New Delhi, looked at existing studies to compare KMC with conventional care and to compare starting the intervention within 24 hours of birth versus a later start.

Mortality risk reduction

Analysis showed that, compared with conventional care, KMC appeared to cut mortality risk by 32% (relative risk, 0.68; 95% confidence interval, 0.53-0.86) during birth hospitalization or by 28 days after birth, while it seemed to reduce the risk of severe infection, such as sepsis, by 15% (RR, 0.85; 95% CI, 0.76-0.96; low-certainty evidence.)

That mortality-risk reduction was found regardless of gestational age or weight of the child at enrolment, time of starting KMC, and whether the intervention was started in a hospital or community.

The studies that had compared early with late-initiated KMC showed a reduction in neonatal mortality of 33%.

Low- and middle-income countries have the highest rates of premature births (gestational age of less than 37 weeks) and low birthweight (less than 2,500 grams). Premature births and low birthweight both are key causes of death and disability.

The World Health Organization recommends KMC as the standard of care among low birthweight infants after clinical stabilization. The American Academy of Pediatrics also promotes immediate KMC.
 

Relevance in the U.S.

Grace Chan, MD, MPH, PhD, an epidemiologist and pediatrician with the Harvard School of Public Health, Boston, said though the practice is promoted by the WHO and AAP, recommendations to families vary widely by providers.

She said the health benefits for KMC are numerous. One of the biggest is that skin-to-skin contact can help transfer heat to newborns who may have trouble regulating their own temperature. That is especially important in cold climates in places where there may be insufficient indoor heat.

She said it’s well-known that preterm babies are at higher risk for apnea, and listening to a mother’s heartbeat may stimulate the child to breathe regularly.

Additionally with KMC, there’s an inherent benefit of a mother or caregiver being able to see any change in a newborn’s color immediately when the baby is held so closely, as opposed to a nurse watching several babies at a time in a neonatal intensive care unit.

This is evidence that starting KMC right away is important, because the risk of death for premature and low-weight newborns is highest in the first 24 hours of life, Dr. Chan noted.
 

Barriers of time

There are some barriers, she noted, in that mothers or other caregivers caring for several young children may not have the time to carry a child in a sling for 8 or more hours at a time.

The authors conclude that their findings have policy implications, particularly for low- and middle-income countries: “KMC should be provided to all low birth weight and preterm infants irrespective of the settings – both health facilities and at home,” they wrote.

The authors caution that, “very low birth weight, extremely preterm neonates, and severely unstable neonates were often excluded from studies. More evidence is needed before extrapolating the study results in these high-risk groups.”

The study authors and Dr. Chan report no relevant financial relationships.

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.