Neonatal Medicine

Four years ago, Atrium Health, in Charlotte, N.C., embarked on a dramatic change in how it cares for newborns exposed to opioids in the womb.

Until then, most of the 700 or so babies who underwent opioid withdrawal each year in the hospital system spent their first weeks in a neonatal intensive care unit (NICU), isolated from their parents and treated with regular doses of morphine to ease their symptoms.

Now, most babies stay in the hospital for just a few days under a new approach called Eat, Sleep, Console. These young patients stay in private rooms where they can bond with their parents and volunteer caregivers. The usual course of treatment is no longer extended therapy with opioid replacements. Instead, mothers are encouraged to stay overnight and are taught how to sooth their babies with swaddling, rocking, and cooing.

As a result, the average length of stay for newborns with neonatal abstinence syndrome (NAS) has dropped from 12 days to 6. Use of morphine has fallen by 79%, from 2.25 to 0.45 mg/kg per stay, according to results of a quality improvement pilot project at one of Atrium’s community hospitals.

Similar outcomes from other hospitals around the country have led to widespread uptake of Eat, Sleep, Console since its advent in 2017. That year, according to federal data, seven newborns were diagnosed with NAS for every 1,000 births.

Advocates say the family-centric model helps parents feel less stigmatized and more confident in their ability to care for their babies, who can have symptoms such as irritability and difficulty feeding for months.

The approach “really empowers families to do what they do best, which is take care of each other,” Douglas Dodds, MD, a pediatrician who led the effort at Atrium, told this news organization.
 

Questioning the old protocols

Numerous state perinatal collaboratives, hospital associations, and health systems say the program is the new standard of care for infants with NAS and neonatal opioid withdrawal syndrome (NOWS).

Twenty-six hospitals have adopted Eat, Sleep, Console as part of a clinical trial sponsored by the National Institutes of Health and a program called Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). Researchers are comparing the approach to previous care protocols in regard to 12 outcomes, including time to medical readiness for discharge, frequency of opioid replacement therapy, and safety problems, such as seizures during treatment.

The transition has been swift. Less than a decade ago, most hospitals used the Finnegan Neonatal Abstinence Scoring System, which was developed in the 1970s to assess babies whose mothers had used heroin during pregnancy.

The Finnegan score entails monitoring babies every 3 hours for 21 symptoms, including high-pitched crying, sneezing, gastrointestinal problems, and yawning. If a baby scores an 8 or more three times in a row, most protocols using the traditional Finnegan approach recommend that providers move infants to an NICU, where they receive morphine or methadone. Once opioid replacement therapy is started, the protocols require a gradual weaning that lasts 3-4 weeks.

As the opioid epidemic grew and NICUs around the country began to fill with babies experiencing NAS or NOW, some clinicians began to question the Finnegan-driven approach.

“You have these miserable babies who are going through this really tough experience, and our first move is to separate them from their moms,” said Matthew Grossman, MD, a pediatric hospitalist at Yale New Haven Children’s Hospital, New Haven, Conn., who created Eat, Sleep, Console.

Dr. Grossman, associate professor and vice chair for quality in the department of pediatrics at Yale University, said he noticed that when mothers stayed overnight with their babies, the infants tended to have fewer withdrawal symptoms. Indeed, previous studies had demonstrated the benefits of breastfeeding and allowing mothers and babies to share a room.

“If you think of mom as a medicine, then you can’t put the baby in a unit where the mom can’t be there,” Dr. Grossman told this news organization. “It would be like taking a kid with pneumonia and putting him in a unit that doesn’t have antibiotics.”

Despite its prominence, the Finnegan score has never been validated for guiding the treatment of NAS. In addition, Finnegan scores can be inconsistent, and the assessment requires disturbing an infant to check signs such as its startle reflex, which, as Dr. Grossman and his fellow researchers pointed out, flies in the face of American Academy of Pediatrics’ recommendations to prioritize swaddling and minimize stimulation for infants with NAS.

By contrast, Eat, Sleep, Console offers a simplified assessment. Interventions are called for if a baby eats less than an ounce of food at a time/does not breastfeed, sleeps less than an hour at a stretch, or takes more than 10 minutes to be consoled. After nonpharmacologic interventions have been tried, doses of medication are used as needed. Babies who are doing well can be discharged in as few as 4 days.
 

Quashing bias against parents with substance abuse disorder

Even with the promise of shorter stays and better care, switching to nonpharmacologic care presents hurdles for hospitals. Among these is a lack of physical space for mothers to room with their babies in a quiet environment.

“In many community hospitals, the only place for infants to go is a neonatal intensive care unit, outside of the newborn nursery,” said Stephen Patrick, MD, MPH, associate professor and director of the Center for Child Health Policy at Vanderbilt University, Nashville, Tenn., who researches stigma associated with opioid use during pregnancy.

Administrators at SSM St. Mary’s Hospital in St. Louis initially balked at providing private rooms for mothers and their babies with NAS and NOWS, according to Kimberly Spence, MD, a neonatologist at SSM Health. She said the initial plan was to put the babies in a busy, brightly lit nursery.

But resistance waned as the hospital convinced health plans to pay for private rooms for the 5-7 days it typically takes a baby to go through withdrawal, said Dr. Spence, associate professor of pediatrics at Saint Louis University.

“We were able to provide enough data that this is evidence-based medicine and babies do better with their moms, and that ethically, this is the right thing to do, to reduce transfers to an NICU,” she said.

In addition, news stories about the family-centric approach and shorter stays for infants, along with SSM’s launch of an outpatient clinic to treat pregnant women with opioid use disorder, helped the system to attract more patients and increase its market share, said Dr. Spence.

Another challenge was getting physicians and nurses to set aside any judgments of parents with substance abuse disorder, according to Dr. Grossman and others.

“A lot of faculty and staff on the medical team didn’t feel like we should trust moms with their babies’ medical care” at SSM, Dr. Spence said.

Some hospitals conduct anti-bias training to teach providers that substance abuse is a disease that deserves proper medical treatment and not the moral failing of a patient. Such education may involve explaining that babies’ outcomes are improved when women undergo treatment with methadone or buprenorphine during pregnancy, even though use of those medications does pose a risk of NAS.

Creating a system that supports parents with substance abuse disorders may help to change perceptions. At Atrium Health, some staff members now enjoy working with these families because they can make a profound impact, Dr. Dodds said. He said they’ve learned that families suffering from substance abuse disorder “are not that different than any other family.”

Dr. Dodds, Dr. Patrick, Dr. Spence, and Dr. Grossman reported no relevant financial relationships.

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

Four years ago, Atrium Health, in Charlotte, N.C., embarked on a dramatic change in how it cares for newborns exposed to opioids in the womb.

Until then, most of the 700 or so babies who underwent opioid withdrawal each year in the hospital system spent their first weeks in a neonatal intensive care unit (NICU), isolated from their parents and treated with regular doses of morphine to ease their symptoms.

Now, most babies stay in the hospital for just a few days under a new approach called Eat, Sleep, Console. These young patients stay in private rooms where they can bond with their parents and volunteer caregivers. The usual course of treatment is no longer extended therapy with opioid replacements. Instead, mothers are encouraged to stay overnight and are taught how to sooth their babies with swaddling, rocking, and cooing.

As a result, the average length of stay for newborns with neonatal abstinence syndrome (NAS) has dropped from 12 days to 6. Use of morphine has fallen by 79%, from 2.25 to 0.45 mg/kg per stay, according to results of a quality improvement pilot project at one of Atrium’s community hospitals.

Similar outcomes from other hospitals around the country have led to widespread uptake of Eat, Sleep, Console since its advent in 2017. That year, according to federal data, seven newborns were diagnosed with NAS for every 1,000 births.

Advocates say the family-centric model helps parents feel less stigmatized and more confident in their ability to care for their babies, who can have symptoms such as irritability and difficulty feeding for months.

The approach “really empowers families to do what they do best, which is take care of each other,” Douglas Dodds, MD, a pediatrician who led the effort at Atrium, told this news organization.
 

Questioning the old protocols

Numerous state perinatal collaboratives, hospital associations, and health systems say the program is the new standard of care for infants with NAS and neonatal opioid withdrawal syndrome (NOWS).

Twenty-six hospitals have adopted Eat, Sleep, Console as part of a clinical trial sponsored by the National Institutes of Health and a program called Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). Researchers are comparing the approach to previous care protocols in regard to 12 outcomes, including time to medical readiness for discharge, frequency of opioid replacement therapy, and safety problems, such as seizures during treatment.

The transition has been swift. Less than a decade ago, most hospitals used the Finnegan Neonatal Abstinence Scoring System, which was developed in the 1970s to assess babies whose mothers had used heroin during pregnancy.

The Finnegan score entails monitoring babies every 3 hours for 21 symptoms, including high-pitched crying, sneezing, gastrointestinal problems, and yawning. If a baby scores an 8 or more three times in a row, most protocols using the traditional Finnegan approach recommend that providers move infants to an NICU, where they receive morphine or methadone. Once opioid replacement therapy is started, the protocols require a gradual weaning that lasts 3-4 weeks.

As the opioid epidemic grew and NICUs around the country began to fill with babies experiencing NAS or NOW, some clinicians began to question the Finnegan-driven approach.

“You have these miserable babies who are going through this really tough experience, and our first move is to separate them from their moms,” said Matthew Grossman, MD, a pediatric hospitalist at Yale New Haven Children’s Hospital, New Haven, Conn., who created Eat, Sleep, Console.

Dr. Grossman, associate professor and vice chair for quality in the department of pediatrics at Yale University, said he noticed that when mothers stayed overnight with their babies, the infants tended to have fewer withdrawal symptoms. Indeed, previous studies had demonstrated the benefits of breastfeeding and allowing mothers and babies to share a room.

“If you think of mom as a medicine, then you can’t put the baby in a unit where the mom can’t be there,” Dr. Grossman told this news organization. “It would be like taking a kid with pneumonia and putting him in a unit that doesn’t have antibiotics.”

Despite its prominence, the Finnegan score has never been validated for guiding the treatment of NAS. In addition, Finnegan scores can be inconsistent, and the assessment requires disturbing an infant to check signs such as its startle reflex, which, as Dr. Grossman and his fellow researchers pointed out, flies in the face of American Academy of Pediatrics’ recommendations to prioritize swaddling and minimize stimulation for infants with NAS.

By contrast, Eat, Sleep, Console offers a simplified assessment. Interventions are called for if a baby eats less than an ounce of food at a time/does not breastfeed, sleeps less than an hour at a stretch, or takes more than 10 minutes to be consoled. After nonpharmacologic interventions have been tried, doses of medication are used as needed. Babies who are doing well can be discharged in as few as 4 days.
 

Quashing bias against parents with substance abuse disorder

Even with the promise of shorter stays and better care, switching to nonpharmacologic care presents hurdles for hospitals. Among these is a lack of physical space for mothers to room with their babies in a quiet environment.

“In many community hospitals, the only place for infants to go is a neonatal intensive care unit, outside of the newborn nursery,” said Stephen Patrick, MD, MPH, associate professor and director of the Center for Child Health Policy at Vanderbilt University, Nashville, Tenn., who researches stigma associated with opioid use during pregnancy.

Administrators at SSM St. Mary’s Hospital in St. Louis initially balked at providing private rooms for mothers and their babies with NAS and NOWS, according to Kimberly Spence, MD, a neonatologist at SSM Health. She said the initial plan was to put the babies in a busy, brightly lit nursery.

But resistance waned as the hospital convinced health plans to pay for private rooms for the 5-7 days it typically takes a baby to go through withdrawal, said Dr. Spence, associate professor of pediatrics at Saint Louis University.

“We were able to provide enough data that this is evidence-based medicine and babies do better with their moms, and that ethically, this is the right thing to do, to reduce transfers to an NICU,” she said.

In addition, news stories about the family-centric approach and shorter stays for infants, along with SSM’s launch of an outpatient clinic to treat pregnant women with opioid use disorder, helped the system to attract more patients and increase its market share, said Dr. Spence.

Another challenge was getting physicians and nurses to set aside any judgments of parents with substance abuse disorder, according to Dr. Grossman and others.

“A lot of faculty and staff on the medical team didn’t feel like we should trust moms with their babies’ medical care” at SSM, Dr. Spence said.

Some hospitals conduct anti-bias training to teach providers that substance abuse is a disease that deserves proper medical treatment and not the moral failing of a patient. Such education may involve explaining that babies’ outcomes are improved when women undergo treatment with methadone or buprenorphine during pregnancy, even though use of those medications does pose a risk of NAS.

Creating a system that supports parents with substance abuse disorders may help to change perceptions. At Atrium Health, some staff members now enjoy working with these families because they can make a profound impact, Dr. Dodds said. He said they’ve learned that families suffering from substance abuse disorder “are not that different than any other family.”

Dr. Dodds, Dr. Patrick, Dr. Spence, and Dr. Grossman reported no relevant financial relationships.

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

Four years ago, Atrium Health, in Charlotte, N.C., embarked on a dramatic change in how it cares for newborns exposed to opioids in the womb.

Until then, most of the 700 or so babies who underwent opioid withdrawal each year in the hospital system spent their first weeks in a neonatal intensive care unit (NICU), isolated from their parents and treated with regular doses of morphine to ease their symptoms.

Now, most babies stay in the hospital for just a few days under a new approach called Eat, Sleep, Console. These young patients stay in private rooms where they can bond with their parents and volunteer caregivers. The usual course of treatment is no longer extended therapy with opioid replacements. Instead, mothers are encouraged to stay overnight and are taught how to sooth their babies with swaddling, rocking, and cooing.

As a result, the average length of stay for newborns with neonatal abstinence syndrome (NAS) has dropped from 12 days to 6. Use of morphine has fallen by 79%, from 2.25 to 0.45 mg/kg per stay, according to results of a quality improvement pilot project at one of Atrium’s community hospitals.

Similar outcomes from other hospitals around the country have led to widespread uptake of Eat, Sleep, Console since its advent in 2017. That year, according to federal data, seven newborns were diagnosed with NAS for every 1,000 births.

Advocates say the family-centric model helps parents feel less stigmatized and more confident in their ability to care for their babies, who can have symptoms such as irritability and difficulty feeding for months.

The approach “really empowers families to do what they do best, which is take care of each other,” Douglas Dodds, MD, a pediatrician who led the effort at Atrium, told this news organization.
 

Questioning the old protocols

Numerous state perinatal collaboratives, hospital associations, and health systems say the program is the new standard of care for infants with NAS and neonatal opioid withdrawal syndrome (NOWS).

Twenty-six hospitals have adopted Eat, Sleep, Console as part of a clinical trial sponsored by the National Institutes of Health and a program called Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). Researchers are comparing the approach to previous care protocols in regard to 12 outcomes, including time to medical readiness for discharge, frequency of opioid replacement therapy, and safety problems, such as seizures during treatment.

The transition has been swift. Less than a decade ago, most hospitals used the Finnegan Neonatal Abstinence Scoring System, which was developed in the 1970s to assess babies whose mothers had used heroin during pregnancy.

The Finnegan score entails monitoring babies every 3 hours for 21 symptoms, including high-pitched crying, sneezing, gastrointestinal problems, and yawning. If a baby scores an 8 or more three times in a row, most protocols using the traditional Finnegan approach recommend that providers move infants to an NICU, where they receive morphine or methadone. Once opioid replacement therapy is started, the protocols require a gradual weaning that lasts 3-4 weeks.

As the opioid epidemic grew and NICUs around the country began to fill with babies experiencing NAS or NOW, some clinicians began to question the Finnegan-driven approach.

“You have these miserable babies who are going through this really tough experience, and our first move is to separate them from their moms,” said Matthew Grossman, MD, a pediatric hospitalist at Yale New Haven Children’s Hospital, New Haven, Conn., who created Eat, Sleep, Console.

Dr. Grossman, associate professor and vice chair for quality in the department of pediatrics at Yale University, said he noticed that when mothers stayed overnight with their babies, the infants tended to have fewer withdrawal symptoms. Indeed, previous studies had demonstrated the benefits of breastfeeding and allowing mothers and babies to share a room.

“If you think of mom as a medicine, then you can’t put the baby in a unit where the mom can’t be there,” Dr. Grossman told this news organization. “It would be like taking a kid with pneumonia and putting him in a unit that doesn’t have antibiotics.”

Despite its prominence, the Finnegan score has never been validated for guiding the treatment of NAS. In addition, Finnegan scores can be inconsistent, and the assessment requires disturbing an infant to check signs such as its startle reflex, which, as Dr. Grossman and his fellow researchers pointed out, flies in the face of American Academy of Pediatrics’ recommendations to prioritize swaddling and minimize stimulation for infants with NAS.

By contrast, Eat, Sleep, Console offers a simplified assessment. Interventions are called for if a baby eats less than an ounce of food at a time/does not breastfeed, sleeps less than an hour at a stretch, or takes more than 10 minutes to be consoled. After nonpharmacologic interventions have been tried, doses of medication are used as needed. Babies who are doing well can be discharged in as few as 4 days.
 

Quashing bias against parents with substance abuse disorder

Even with the promise of shorter stays and better care, switching to nonpharmacologic care presents hurdles for hospitals. Among these is a lack of physical space for mothers to room with their babies in a quiet environment.

“In many community hospitals, the only place for infants to go is a neonatal intensive care unit, outside of the newborn nursery,” said Stephen Patrick, MD, MPH, associate professor and director of the Center for Child Health Policy at Vanderbilt University, Nashville, Tenn., who researches stigma associated with opioid use during pregnancy.

Administrators at SSM St. Mary’s Hospital in St. Louis initially balked at providing private rooms for mothers and their babies with NAS and NOWS, according to Kimberly Spence, MD, a neonatologist at SSM Health. She said the initial plan was to put the babies in a busy, brightly lit nursery.

But resistance waned as the hospital convinced health plans to pay for private rooms for the 5-7 days it typically takes a baby to go through withdrawal, said Dr. Spence, associate professor of pediatrics at Saint Louis University.

“We were able to provide enough data that this is evidence-based medicine and babies do better with their moms, and that ethically, this is the right thing to do, to reduce transfers to an NICU,” she said.

In addition, news stories about the family-centric approach and shorter stays for infants, along with SSM’s launch of an outpatient clinic to treat pregnant women with opioid use disorder, helped the system to attract more patients and increase its market share, said Dr. Spence.

Another challenge was getting physicians and nurses to set aside any judgments of parents with substance abuse disorder, according to Dr. Grossman and others.

“A lot of faculty and staff on the medical team didn’t feel like we should trust moms with their babies’ medical care” at SSM, Dr. Spence said.

Some hospitals conduct anti-bias training to teach providers that substance abuse is a disease that deserves proper medical treatment and not the moral failing of a patient. Such education may involve explaining that babies’ outcomes are improved when women undergo treatment with methadone or buprenorphine during pregnancy, even though use of those medications does pose a risk of NAS.

Creating a system that supports parents with substance abuse disorders may help to change perceptions. At Atrium Health, some staff members now enjoy working with these families because they can make a profound impact, Dr. Dodds said. He said they’ve learned that families suffering from substance abuse disorder “are not that different than any other family.”

Dr. Dodds, Dr. Patrick, Dr. Spence, and Dr. Grossman reported no relevant financial relationships.

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

Pregnant women who get infected with SARS-CoV-2 in their third trimester are almost three times as likely to have a preterm birth, while infection after 34 weeks’ gestation raises this risk sevenfold, based on the largest matched population-based cohort study published to date.

These findings support previous studies, underscoring the need for pregnant women and their families to take preventive measures against infection, lead author Noga Fallach, MA, of the Kahn-Sagol-Maccabi Research and Innovation Center, Tel Aviv, and colleagues reported.

ArtMarie/E+/Getty Images

Past research has suggested that COVID-19 may cause low birth weights and preterm birth in pregnant women, but those studies didn’t report outcomes for each trimester, the investigators wrote in PLoS ONE, noting that “timing of viral infection during fetal development may affect birth and other health outcomes.”

To address this knowledge gap, the investigators looked back at data from 2,703 pregnant women in Israel who tested positive for SARS-CoV-2 from Feb. 21, 2020, to July 2, 2021. Pregnancy outcomes in these women were compared with outcomes in an equal number of uninfected pregnant women. Vaccination status was not reported.

Comparing the two groups showed that catching COVID-19 in the third trimester was linked with nearly triple the risk of preterm birth (odds ratio, 2.76; 95% confidence interval, 1.63-4.67), and more than quadruple the risk if COVID-19 symptoms were present (OR, 4.28; 95% CI, 1.94-9.41). Women who tested positive for SARS-CoV-2 after 34 weeks’ gestation were seven times more likely than uninfected women to deliver early (OR, 7.10; 95% CI, 2.44-20.61).

Pregnant women who caught COVID-19 in the first two trimesters were not significantly more likely to have a preterm birth. Infection was not associated with abnormally low birth rates, or pregnancy loss, in any trimester.

Tal Patalon, MD, coauthor and head of the Kahn-Sagol-Maccabi Research and Innovation Center, focused on these more optimistic findings in an interview.

“The results are encouraging, and reassuring that COVID-19 infection during pregnancy is not associated with any type of pregnancy loss,” Dr. Patalon said.

She also pointed out that the women in the study were infected with SARS-CoV-2 variants that are no longer common.

“It should be remembered that the research group tested the COVID-19 pre-Delta variants, and does not refer to the dominant variant today, which is Omicron,” Dr. Patalon said.

Still, the investigators concluded that the “results underline the importance of preventive measures taken against SARS-CoV-2 infection among pregnant women and their families.”

Sonja A. Rasmussen, MD, of the University of Florida, Gainesville, said that the issue with out-of-date variants in published research has been one of the “real challenges” in studying the ever-evolving COVID-19 pandemic; however, it’s not a good enough reason to dismiss this study.

“I think at this point, we need to assume that it applies to Omicron too,” Dr. Rasmussen said, noting that other respiratory viruses, like influenza, have also been shown to increase the risk of preterm birth when contracted in late pregnancy.

While the present findings highlight the risk of infection in the third trimester, Dr. Rasmussen advised women in all stages of pregnancy to protect themselves against COVID-19, based on the knowledge that illness in a mother can affect normal growth and development in a fetus, even if it doesn’t lead to preterm birth.

“A mom getting sick during pregnancy is not good for the baby,” Dr. Rasmussen said. “The baby’s really dependent on the mom. So you want that baby to have good nutrition throughout the pregnancy. It’s just as important earlier on as later. And you want that baby to get good oxygenation no matter what time [in the pregnancy]. I know that people want a little bit of a break [from preventive measures]. But I would emphasize that if you’re pregnant, we do all sorts of things during pregnancy to make sure that our babies are safe and healthy, and I would continue that for the whole pregnancy.”

Specifically, Dr. Rasmussen advised social distancing, use of an N95 mask, and vaccination. Getting vaccinated during pregnancy helps newborns fight off infection until 6 months of age, she added, when they become eligible for vaccination themselves. This added benefit was recently reported in a study published in the New England Journal of Medicine , for which Dr. Rasmussen cowrote an editorial .

“Vaccines have been approved for 6 months and older,” Dr. Rasmussen said. “But what do you do in those first 6 months of life? That’s a high-risk time for kids.”

Despite these risks, convincing pregnant women to get vaccinated remains a key challenge for health care providers, according to Dr. Rasmussen, even with an abundance of safety data. “Early on [in the pandemic], we said we didn’t know a lot about risks. We knew that other vaccines were safe during pregnancy, but we didn’t have a lot of information about a COVID-19 vaccine. But now we have a lot of data on safety during pregnancy, and these vaccines appear to be completely safe, based on the information we have. There have been many, many pregnant women vaccinated in the United States and in other countries.”

For reluctant expecting mothers, Dr. Rasmussen offered some words of advice: “I know that you worry about anything you do when you’re pregnant. But this is something that you can do to help your baby – now, to make a preterm birth less likely, and later, after the baby is born.

“The most important thing is for the pregnant person to hear this [vaccine recommendation] from their doctor,” she added. “If they’re going to listen to anybody, they’re going to listen to their physician. That’s what the data have shown for a long time.”

The investigators and Dr. Rasmussen disclosed no conflicts of interest.

Pregnant women who get infected with SARS-CoV-2 in their third trimester are almost three times as likely to have a preterm birth, while infection after 34 weeks’ gestation raises this risk sevenfold, based on the largest matched population-based cohort study published to date.

These findings support previous studies, underscoring the need for pregnant women and their families to take preventive measures against infection, lead author Noga Fallach, MA, of the Kahn-Sagol-Maccabi Research and Innovation Center, Tel Aviv, and colleagues reported.

ArtMarie/E+/Getty Images

Past research has suggested that COVID-19 may cause low birth weights and preterm birth in pregnant women, but those studies didn’t report outcomes for each trimester, the investigators wrote in PLoS ONE, noting that “timing of viral infection during fetal development may affect birth and other health outcomes.”

To address this knowledge gap, the investigators looked back at data from 2,703 pregnant women in Israel who tested positive for SARS-CoV-2 from Feb. 21, 2020, to July 2, 2021. Pregnancy outcomes in these women were compared with outcomes in an equal number of uninfected pregnant women. Vaccination status was not reported.

Comparing the two groups showed that catching COVID-19 in the third trimester was linked with nearly triple the risk of preterm birth (odds ratio, 2.76; 95% confidence interval, 1.63-4.67), and more than quadruple the risk if COVID-19 symptoms were present (OR, 4.28; 95% CI, 1.94-9.41). Women who tested positive for SARS-CoV-2 after 34 weeks’ gestation were seven times more likely than uninfected women to deliver early (OR, 7.10; 95% CI, 2.44-20.61).

Pregnant women who caught COVID-19 in the first two trimesters were not significantly more likely to have a preterm birth. Infection was not associated with abnormally low birth rates, or pregnancy loss, in any trimester.

Tal Patalon, MD, coauthor and head of the Kahn-Sagol-Maccabi Research and Innovation Center, focused on these more optimistic findings in an interview.

“The results are encouraging, and reassuring that COVID-19 infection during pregnancy is not associated with any type of pregnancy loss,” Dr. Patalon said.

She also pointed out that the women in the study were infected with SARS-CoV-2 variants that are no longer common.

“It should be remembered that the research group tested the COVID-19 pre-Delta variants, and does not refer to the dominant variant today, which is Omicron,” Dr. Patalon said.

Still, the investigators concluded that the “results underline the importance of preventive measures taken against SARS-CoV-2 infection among pregnant women and their families.”

Sonja A. Rasmussen, MD, of the University of Florida, Gainesville, said that the issue with out-of-date variants in published research has been one of the “real challenges” in studying the ever-evolving COVID-19 pandemic; however, it’s not a good enough reason to dismiss this study.

“I think at this point, we need to assume that it applies to Omicron too,” Dr. Rasmussen said, noting that other respiratory viruses, like influenza, have also been shown to increase the risk of preterm birth when contracted in late pregnancy.

While the present findings highlight the risk of infection in the third trimester, Dr. Rasmussen advised women in all stages of pregnancy to protect themselves against COVID-19, based on the knowledge that illness in a mother can affect normal growth and development in a fetus, even if it doesn’t lead to preterm birth.

“A mom getting sick during pregnancy is not good for the baby,” Dr. Rasmussen said. “The baby’s really dependent on the mom. So you want that baby to have good nutrition throughout the pregnancy. It’s just as important earlier on as later. And you want that baby to get good oxygenation no matter what time [in the pregnancy]. I know that people want a little bit of a break [from preventive measures]. But I would emphasize that if you’re pregnant, we do all sorts of things during pregnancy to make sure that our babies are safe and healthy, and I would continue that for the whole pregnancy.”

Specifically, Dr. Rasmussen advised social distancing, use of an N95 mask, and vaccination. Getting vaccinated during pregnancy helps newborns fight off infection until 6 months of age, she added, when they become eligible for vaccination themselves. This added benefit was recently reported in a study published in the New England Journal of Medicine , for which Dr. Rasmussen cowrote an editorial .

“Vaccines have been approved for 6 months and older,” Dr. Rasmussen said. “But what do you do in those first 6 months of life? That’s a high-risk time for kids.”

Despite these risks, convincing pregnant women to get vaccinated remains a key challenge for health care providers, according to Dr. Rasmussen, even with an abundance of safety data. “Early on [in the pandemic], we said we didn’t know a lot about risks. We knew that other vaccines were safe during pregnancy, but we didn’t have a lot of information about a COVID-19 vaccine. But now we have a lot of data on safety during pregnancy, and these vaccines appear to be completely safe, based on the information we have. There have been many, many pregnant women vaccinated in the United States and in other countries.”

For reluctant expecting mothers, Dr. Rasmussen offered some words of advice: “I know that you worry about anything you do when you’re pregnant. But this is something that you can do to help your baby – now, to make a preterm birth less likely, and later, after the baby is born.

“The most important thing is for the pregnant person to hear this [vaccine recommendation] from their doctor,” she added. “If they’re going to listen to anybody, they’re going to listen to their physician. That’s what the data have shown for a long time.”

The investigators and Dr. Rasmussen disclosed no conflicts of interest.

Pregnant women who get infected with SARS-CoV-2 in their third trimester are almost three times as likely to have a preterm birth, while infection after 34 weeks’ gestation raises this risk sevenfold, based on the largest matched population-based cohort study published to date.

These findings support previous studies, underscoring the need for pregnant women and their families to take preventive measures against infection, lead author Noga Fallach, MA, of the Kahn-Sagol-Maccabi Research and Innovation Center, Tel Aviv, and colleagues reported.

ArtMarie/E+/Getty Images

Past research has suggested that COVID-19 may cause low birth weights and preterm birth in pregnant women, but those studies didn’t report outcomes for each trimester, the investigators wrote in PLoS ONE, noting that “timing of viral infection during fetal development may affect birth and other health outcomes.”

To address this knowledge gap, the investigators looked back at data from 2,703 pregnant women in Israel who tested positive for SARS-CoV-2 from Feb. 21, 2020, to July 2, 2021. Pregnancy outcomes in these women were compared with outcomes in an equal number of uninfected pregnant women. Vaccination status was not reported.

Comparing the two groups showed that catching COVID-19 in the third trimester was linked with nearly triple the risk of preterm birth (odds ratio, 2.76; 95% confidence interval, 1.63-4.67), and more than quadruple the risk if COVID-19 symptoms were present (OR, 4.28; 95% CI, 1.94-9.41). Women who tested positive for SARS-CoV-2 after 34 weeks’ gestation were seven times more likely than uninfected women to deliver early (OR, 7.10; 95% CI, 2.44-20.61).

Pregnant women who caught COVID-19 in the first two trimesters were not significantly more likely to have a preterm birth. Infection was not associated with abnormally low birth rates, or pregnancy loss, in any trimester.

Tal Patalon, MD, coauthor and head of the Kahn-Sagol-Maccabi Research and Innovation Center, focused on these more optimistic findings in an interview.

“The results are encouraging, and reassuring that COVID-19 infection during pregnancy is not associated with any type of pregnancy loss,” Dr. Patalon said.

She also pointed out that the women in the study were infected with SARS-CoV-2 variants that are no longer common.

“It should be remembered that the research group tested the COVID-19 pre-Delta variants, and does not refer to the dominant variant today, which is Omicron,” Dr. Patalon said.

Still, the investigators concluded that the “results underline the importance of preventive measures taken against SARS-CoV-2 infection among pregnant women and their families.”

Sonja A. Rasmussen, MD, of the University of Florida, Gainesville, said that the issue with out-of-date variants in published research has been one of the “real challenges” in studying the ever-evolving COVID-19 pandemic; however, it’s not a good enough reason to dismiss this study.

“I think at this point, we need to assume that it applies to Omicron too,” Dr. Rasmussen said, noting that other respiratory viruses, like influenza, have also been shown to increase the risk of preterm birth when contracted in late pregnancy.

While the present findings highlight the risk of infection in the third trimester, Dr. Rasmussen advised women in all stages of pregnancy to protect themselves against COVID-19, based on the knowledge that illness in a mother can affect normal growth and development in a fetus, even if it doesn’t lead to preterm birth.

“A mom getting sick during pregnancy is not good for the baby,” Dr. Rasmussen said. “The baby’s really dependent on the mom. So you want that baby to have good nutrition throughout the pregnancy. It’s just as important earlier on as later. And you want that baby to get good oxygenation no matter what time [in the pregnancy]. I know that people want a little bit of a break [from preventive measures]. But I would emphasize that if you’re pregnant, we do all sorts of things during pregnancy to make sure that our babies are safe and healthy, and I would continue that for the whole pregnancy.”

Specifically, Dr. Rasmussen advised social distancing, use of an N95 mask, and vaccination. Getting vaccinated during pregnancy helps newborns fight off infection until 6 months of age, she added, when they become eligible for vaccination themselves. This added benefit was recently reported in a study published in the New England Journal of Medicine , for which Dr. Rasmussen cowrote an editorial .

“Vaccines have been approved for 6 months and older,” Dr. Rasmussen said. “But what do you do in those first 6 months of life? That’s a high-risk time for kids.”

Despite these risks, convincing pregnant women to get vaccinated remains a key challenge for health care providers, according to Dr. Rasmussen, even with an abundance of safety data. “Early on [in the pandemic], we said we didn’t know a lot about risks. We knew that other vaccines were safe during pregnancy, but we didn’t have a lot of information about a COVID-19 vaccine. But now we have a lot of data on safety during pregnancy, and these vaccines appear to be completely safe, based on the information we have. There have been many, many pregnant women vaccinated in the United States and in other countries.”

For reluctant expecting mothers, Dr. Rasmussen offered some words of advice: “I know that you worry about anything you do when you’re pregnant. But this is something that you can do to help your baby – now, to make a preterm birth less likely, and later, after the baby is born.

“The most important thing is for the pregnant person to hear this [vaccine recommendation] from their doctor,” she added. “If they’re going to listen to anybody, they’re going to listen to their physician. That’s what the data have shown for a long time.”

The investigators and Dr. Rasmussen disclosed no conflicts of interest.

The American Academy of Pediatrics is built on good intentions. It wants the best for children in the world, and it hopes to support its members in their efforts to achieve this goal. But from time to time, the academy loses sight of reality and makes recommendations that are counterproductive to its stated goals.

The recent release of its new policy “Breastfeeding and the Use of Human Milk” is another unfortunate example of poorly aimed recommendations. A careful reading of the document reveals it to be a well-researched treatise on breastfeeding and the value of human milk, including a discussion of the numerous impediments to the universal adoption of breastfeeding in our society. However, when a document of this breadth and complexity is released to the public it is never surprising that the messages deserving the most attention are lost in the press coverage. Most of the headlines I saw mentioned pediatricians supporting breastfeeding for a year or 2.

Who was the target audience? If it was pediatricians, most of us don’t need a longer list of the health benefits of breastfeeding. We already believe it is the best nutritional source for human babies and realize that the institutional framework in this country continues to be unfriendly to women who intend to breastfeed.

If the audience is politicians and public health decision-makers, the new policy contains a wealth of supportive evidence. However, most pediatricians I know are too busy or lack the skills and enthusiasm to become political activists. For the rest of population, including parents, the recommendations represent a collection of TMI (too much information).

If the audience is women who are considering breastfeeding I suspect nearly 100% already know pediatricians think it is the preferred way to feed their babies. And, likewise, a longer list won’t convince them to try nursing. Additional evidence may simply make them feel more guilty when they aren’t successful.

Many pregnant women have already been told that breastfeeding can be a challenge and given their situation breast milk alone for the first 6 months may sound like an unreasonable goal. The new recommendation that breastfeeding for a year or 2 is good is not a message they want to hear.

On the other hand, if the target audience is women who will be comforted to hear an official statement that normalizes breastfeeding longer than a year, the new policy statement has hit the nail on the head.

Of course the new policy document is sprinkled with caveats that vaguely hint at the possibility that pediatricians are sensitive human beings who under certain circumstances may be able to compromise when it comes to the duration of breastfeeding and the introduction of formula. But this whiff of reality is certainly not the dominant odor in these new recommendations.

Don’t get me wrong: I think the academy was overdue for a policy revision on breastfeeding. However, it should have been one that was reality based. It should acknowledge that there are institutional and societal biases against breastfeeding, and it should remind pediatricians that they can effect change by discussing these realities honestly with parents, while making it clear that we are there for them and their children regardless of how they feed their baby. Pediatricians believe that breastfeeding is the best but not the only way to feed a baby. We have (or will provide) the skills to assist parents succeed in whatever method they choose and strive to minimize the impediments that are within our power to change.

If the academy had chosen to release a separate statement simply supporting mothers who chose to nurse longer than a year, then that would have been a good idea. However, when presented as part of the larger document, that message dominated in the media and only served to fuel the guilt that many new mothers must endure.
 

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].

The American Academy of Pediatrics is built on good intentions. It wants the best for children in the world, and it hopes to support its members in their efforts to achieve this goal. But from time to time, the academy loses sight of reality and makes recommendations that are counterproductive to its stated goals.

The recent release of its new policy “Breastfeeding and the Use of Human Milk” is another unfortunate example of poorly aimed recommendations. A careful reading of the document reveals it to be a well-researched treatise on breastfeeding and the value of human milk, including a discussion of the numerous impediments to the universal adoption of breastfeeding in our society. However, when a document of this breadth and complexity is released to the public it is never surprising that the messages deserving the most attention are lost in the press coverage. Most of the headlines I saw mentioned pediatricians supporting breastfeeding for a year or 2.

Who was the target audience? If it was pediatricians, most of us don’t need a longer list of the health benefits of breastfeeding. We already believe it is the best nutritional source for human babies and realize that the institutional framework in this country continues to be unfriendly to women who intend to breastfeed.

If the audience is politicians and public health decision-makers, the new policy contains a wealth of supportive evidence. However, most pediatricians I know are too busy or lack the skills and enthusiasm to become political activists. For the rest of population, including parents, the recommendations represent a collection of TMI (too much information).

If the audience is women who are considering breastfeeding I suspect nearly 100% already know pediatricians think it is the preferred way to feed their babies. And, likewise, a longer list won’t convince them to try nursing. Additional evidence may simply make them feel more guilty when they aren’t successful.

Many pregnant women have already been told that breastfeeding can be a challenge and given their situation breast milk alone for the first 6 months may sound like an unreasonable goal. The new recommendation that breastfeeding for a year or 2 is good is not a message they want to hear.

On the other hand, if the target audience is women who will be comforted to hear an official statement that normalizes breastfeeding longer than a year, the new policy statement has hit the nail on the head.

Of course the new policy document is sprinkled with caveats that vaguely hint at the possibility that pediatricians are sensitive human beings who under certain circumstances may be able to compromise when it comes to the duration of breastfeeding and the introduction of formula. But this whiff of reality is certainly not the dominant odor in these new recommendations.

Don’t get me wrong: I think the academy was overdue for a policy revision on breastfeeding. However, it should have been one that was reality based. It should acknowledge that there are institutional and societal biases against breastfeeding, and it should remind pediatricians that they can effect change by discussing these realities honestly with parents, while making it clear that we are there for them and their children regardless of how they feed their baby. Pediatricians believe that breastfeeding is the best but not the only way to feed a baby. We have (or will provide) the skills to assist parents succeed in whatever method they choose and strive to minimize the impediments that are within our power to change.

If the academy had chosen to release a separate statement simply supporting mothers who chose to nurse longer than a year, then that would have been a good idea. However, when presented as part of the larger document, that message dominated in the media and only served to fuel the guilt that many new mothers must endure.
 

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].

The American Academy of Pediatrics is built on good intentions. It wants the best for children in the world, and it hopes to support its members in their efforts to achieve this goal. But from time to time, the academy loses sight of reality and makes recommendations that are counterproductive to its stated goals.

The recent release of its new policy “Breastfeeding and the Use of Human Milk” is another unfortunate example of poorly aimed recommendations. A careful reading of the document reveals it to be a well-researched treatise on breastfeeding and the value of human milk, including a discussion of the numerous impediments to the universal adoption of breastfeeding in our society. However, when a document of this breadth and complexity is released to the public it is never surprising that the messages deserving the most attention are lost in the press coverage. Most of the headlines I saw mentioned pediatricians supporting breastfeeding for a year or 2.

Who was the target audience? If it was pediatricians, most of us don’t need a longer list of the health benefits of breastfeeding. We already believe it is the best nutritional source for human babies and realize that the institutional framework in this country continues to be unfriendly to women who intend to breastfeed.

If the audience is politicians and public health decision-makers, the new policy contains a wealth of supportive evidence. However, most pediatricians I know are too busy or lack the skills and enthusiasm to become political activists. For the rest of population, including parents, the recommendations represent a collection of TMI (too much information).

If the audience is women who are considering breastfeeding I suspect nearly 100% already know pediatricians think it is the preferred way to feed their babies. And, likewise, a longer list won’t convince them to try nursing. Additional evidence may simply make them feel more guilty when they aren’t successful.

Many pregnant women have already been told that breastfeeding can be a challenge and given their situation breast milk alone for the first 6 months may sound like an unreasonable goal. The new recommendation that breastfeeding for a year or 2 is good is not a message they want to hear.

On the other hand, if the target audience is women who will be comforted to hear an official statement that normalizes breastfeeding longer than a year, the new policy statement has hit the nail on the head.

Of course the new policy document is sprinkled with caveats that vaguely hint at the possibility that pediatricians are sensitive human beings who under certain circumstances may be able to compromise when it comes to the duration of breastfeeding and the introduction of formula. But this whiff of reality is certainly not the dominant odor in these new recommendations.

Don’t get me wrong: I think the academy was overdue for a policy revision on breastfeeding. However, it should have been one that was reality based. It should acknowledge that there are institutional and societal biases against breastfeeding, and it should remind pediatricians that they can effect change by discussing these realities honestly with parents, while making it clear that we are there for them and their children regardless of how they feed their baby. Pediatricians believe that breastfeeding is the best but not the only way to feed a baby. We have (or will provide) the skills to assist parents succeed in whatever method they choose and strive to minimize the impediments that are within our power to change.

If the academy had chosen to release a separate statement simply supporting mothers who chose to nurse longer than a year, then that would have been a good idea. However, when presented as part of the larger document, that message dominated in the media and only served to fuel the guilt that many new mothers must endure.
 

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].

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

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

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

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

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

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

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

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

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

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

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

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

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

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].

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

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].

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

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].

LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

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

LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

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

LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

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

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

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

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

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

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

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