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Studies suggest ways to refine neonatal hernia management
WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting,
Initial ventilation mode shows little impact on NICU outcomes
In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.
The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.
Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO2 (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
Prenatal brain immaturity associates with developmental delay
In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.
Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.
In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
Antibiotic use stays stable
In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.
They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).
The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
Studies show larger trends
“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.
The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”
The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.
“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.
Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.
“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.
The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.
WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting,
Initial ventilation mode shows little impact on NICU outcomes
In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.
The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.
Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO2 (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
Prenatal brain immaturity associates with developmental delay
In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.
Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.
In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
Antibiotic use stays stable
In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.
They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).
The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
Studies show larger trends
“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.
The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”
The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.
“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.
Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.
“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.
The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.
WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting,
Initial ventilation mode shows little impact on NICU outcomes
In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.
The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.
Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO2 (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
Prenatal brain immaturity associates with developmental delay
In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.
Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.
In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
Antibiotic use stays stable
In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.
They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).
The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
Studies show larger trends
“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.
The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”
The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.
“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.
Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.
“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.
The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.
AT PAS 2023
The nation’s health secretary has this obstetrician on call
She’s seen progress, albeit slow, over three decades, yet the number of maternal deaths each year continues to rise.
Luckily, she’s got the ear of President Joe Biden’s health secretary.
Dr. Reyes, 64, is married to Health and Human Services Secretary Xavier Becerra, who is championing the administration’s initiative to require all states to provide Medicaid coverage to mothers for a year after giving birth. In March, the Centers for Disease Control and Prevention released data showing a 40% increase in U.S. maternal deaths from 2020 to 2021. The mortality rate among Black women was 2.6 times that of white women, no matter their economic status.
Over the years, Mr. Becerra has spoken highly of his wife’s expertise, but she downplays her influence, saying her husband of nearly 35 years “had it in him to begin with” to improve health care for women and to demand fewer pregnancy-related deaths. She, too, describes the nation’s high maternal mortality rate as unacceptable and preventable.
Dr. Reyes, a Latina who grew up as one of eight children in California’s agricultural heartland, now practices perinatology at the University of California, Davis. She is a member of a California Department of Public Health panel that reviews cases of maternal deaths and recommends improvements. And she chairs the board of the California Health Care Foundation, a nonprofit that works to increase health care access. (California Healthline is an editorially independent service of the California Health Care Foundation.)
Her work has been a blend of medicine and advocacy, and she worries recent federal court rulings will erode hard-fought victories regarding the safety of pregnant women and their babies. She discussed the nation’s maternal health crisis and health care disparities in an interview, which has been edited for length and clarity.
Question: When did you first realize there are disparities in the health care system?
Answer: When I was in high school in the Fresno Unified School District, we were under a consent decree to desegregate. And I was, at the time, student body president at Roosevelt High School. I was asked to be on this unified school district desegregation task force, where the district had to come up with a plan.
It was a time when I really had incredible exposure to how policies are made at a larger level, societal level, that really determine where people live, where they can seek health care, where they go to school. That experience had a tremendous impact on my life in terms of what I wanted to do in a career and how to give back.
Q: The U.S. has one of the best health care systems in the world, yet the maternal mortality rate is high compared with other developed countries. Why do think that is?
A. What we know by the CDC and maternal mortality review committees is that about 60% of maternal deaths are considered preventable. And that’s really been a lot of what I’ve tried to focus on: What can we do to reduce the severity of disease? Or what can we do within the role that we play in maternal health that can reduce that?
We know that there are societal issues absolutely that increase women’s risks and there are public health issues. But there’s a role that hospitals play in helping reduce that risk. Ten years ago, I was on the maternal mortality review committee for the state of California when we started reviewing cases of women who died within hospital systems to see, “Is there a role that we can play in a hospital system to reduce that risk?”
We recognized that sometimes there were conditions that were not recognized early enough so that there was a delay in the care. Sometimes there was a misdiagnosis. Or in some hospital systems, especially rural systems where there aren’t as many resources, sometimes there was the lack of specialists available. So, we’ve identified these risks and said, “We can do something about them.”
Q: You served on a federal panel 20 years ago that published a groundbreaking report identifying racism in health care. It seems as if we could be much further along.
A. The purpose of that committee was to really answer the question: Do patients receive a different level of care based on race? Looking back, we knew there was something there, but we really didn’t know. And it took months for the committee to come to that agreement, that there was a difference. I mean, that was honestly monumental, because we just didn’t have that level of consensus before. And so just to say “That treatment is unequal and it’s unacceptable” was really profound.
We thought that the 700-page report was going to be a time period where there was going to be tremendous movement, and I think I’ve learned over 20 years that change doesn’t happen quickly, especially when providers and health systems don’t see that they play a role. It’s like … “OK, so maybe it exists, but not for me.”
We all saw George Floyd and how he was treated. And during COVID we saw a tremendous difference in who was dying, right? Underrepresented minorities – certainly much higher. It was that culmination that made us realize the elephant in the room. We can’t ignore that this does exist, that there is a difference in how people are treated, even in our health care system.
Q: When addressing racism in health care, you talk about diversifying not just the health care workforce, but also the boardrooms of hospitals and health systems. Why is that important?
A. At the board level, change is hard. But we all play a role because leadership really helps determine much of what’s carried out. So, to have a leadership that is understanding and representative of the communities they serve, I think it has been demonstrated that we do make a difference.
Q: As a health care provider, do you have a wish list of policies you’d like the government to take up?
A. There was tremendous effort around offering preventive health services as a part of what was covered under the Affordable Care Act. And individuals exhaled, finally thinking this is a tremendous win, especially for women in pregnancy. Because we fought for preventive health services to help them have access so they can prepare for their pregnancy. So, for women, this was huge. But now with the Texas federal court ruling that the U.S. Preventive Services Task Force didn’t have any authority, it is a tremendous step backward.
We have culturally, linguistically appropriate standards in place, but it’s a matter in terms of how they’re carried out by state and by individual hospital systems. My wish list is that we really do listen to our patients, speak to them in a language of their choice, and provide them written materials in the language of their choice. We don’t fully do that.
Q: You mentioned one Texas ruling on the ACA. What’s your take on the ruling by another Texas judge suspending the abortion pill? And the U.S. Supreme Court’s overturning of Roe v. Wade?A. As a maternal-fetal medicine specialist who tries to help women plan for pregnancies, those rulings are a tremendous setback.
Q: And what about women of color? Will they find access to abortion services more difficult?
A. Oh, absolutely. When we speak of underrepresented minorities or those with less resources, they have less resources to then seek the appropriate care. Some women may have the opportunity to go to a different state or seek care elsewhere if their state doesn’t provide it. Many women just don’t have those resources to devote to them and don’t have a choice. So, we will see that disparity widen.
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
She’s seen progress, albeit slow, over three decades, yet the number of maternal deaths each year continues to rise.
Luckily, she’s got the ear of President Joe Biden’s health secretary.
Dr. Reyes, 64, is married to Health and Human Services Secretary Xavier Becerra, who is championing the administration’s initiative to require all states to provide Medicaid coverage to mothers for a year after giving birth. In March, the Centers for Disease Control and Prevention released data showing a 40% increase in U.S. maternal deaths from 2020 to 2021. The mortality rate among Black women was 2.6 times that of white women, no matter their economic status.
Over the years, Mr. Becerra has spoken highly of his wife’s expertise, but she downplays her influence, saying her husband of nearly 35 years “had it in him to begin with” to improve health care for women and to demand fewer pregnancy-related deaths. She, too, describes the nation’s high maternal mortality rate as unacceptable and preventable.
Dr. Reyes, a Latina who grew up as one of eight children in California’s agricultural heartland, now practices perinatology at the University of California, Davis. She is a member of a California Department of Public Health panel that reviews cases of maternal deaths and recommends improvements. And she chairs the board of the California Health Care Foundation, a nonprofit that works to increase health care access. (California Healthline is an editorially independent service of the California Health Care Foundation.)
Her work has been a blend of medicine and advocacy, and she worries recent federal court rulings will erode hard-fought victories regarding the safety of pregnant women and their babies. She discussed the nation’s maternal health crisis and health care disparities in an interview, which has been edited for length and clarity.
Question: When did you first realize there are disparities in the health care system?
Answer: When I was in high school in the Fresno Unified School District, we were under a consent decree to desegregate. And I was, at the time, student body president at Roosevelt High School. I was asked to be on this unified school district desegregation task force, where the district had to come up with a plan.
It was a time when I really had incredible exposure to how policies are made at a larger level, societal level, that really determine where people live, where they can seek health care, where they go to school. That experience had a tremendous impact on my life in terms of what I wanted to do in a career and how to give back.
Q: The U.S. has one of the best health care systems in the world, yet the maternal mortality rate is high compared with other developed countries. Why do think that is?
A. What we know by the CDC and maternal mortality review committees is that about 60% of maternal deaths are considered preventable. And that’s really been a lot of what I’ve tried to focus on: What can we do to reduce the severity of disease? Or what can we do within the role that we play in maternal health that can reduce that?
We know that there are societal issues absolutely that increase women’s risks and there are public health issues. But there’s a role that hospitals play in helping reduce that risk. Ten years ago, I was on the maternal mortality review committee for the state of California when we started reviewing cases of women who died within hospital systems to see, “Is there a role that we can play in a hospital system to reduce that risk?”
We recognized that sometimes there were conditions that were not recognized early enough so that there was a delay in the care. Sometimes there was a misdiagnosis. Or in some hospital systems, especially rural systems where there aren’t as many resources, sometimes there was the lack of specialists available. So, we’ve identified these risks and said, “We can do something about them.”
Q: You served on a federal panel 20 years ago that published a groundbreaking report identifying racism in health care. It seems as if we could be much further along.
A. The purpose of that committee was to really answer the question: Do patients receive a different level of care based on race? Looking back, we knew there was something there, but we really didn’t know. And it took months for the committee to come to that agreement, that there was a difference. I mean, that was honestly monumental, because we just didn’t have that level of consensus before. And so just to say “That treatment is unequal and it’s unacceptable” was really profound.
We thought that the 700-page report was going to be a time period where there was going to be tremendous movement, and I think I’ve learned over 20 years that change doesn’t happen quickly, especially when providers and health systems don’t see that they play a role. It’s like … “OK, so maybe it exists, but not for me.”
We all saw George Floyd and how he was treated. And during COVID we saw a tremendous difference in who was dying, right? Underrepresented minorities – certainly much higher. It was that culmination that made us realize the elephant in the room. We can’t ignore that this does exist, that there is a difference in how people are treated, even in our health care system.
Q: When addressing racism in health care, you talk about diversifying not just the health care workforce, but also the boardrooms of hospitals and health systems. Why is that important?
A. At the board level, change is hard. But we all play a role because leadership really helps determine much of what’s carried out. So, to have a leadership that is understanding and representative of the communities they serve, I think it has been demonstrated that we do make a difference.
Q: As a health care provider, do you have a wish list of policies you’d like the government to take up?
A. There was tremendous effort around offering preventive health services as a part of what was covered under the Affordable Care Act. And individuals exhaled, finally thinking this is a tremendous win, especially for women in pregnancy. Because we fought for preventive health services to help them have access so they can prepare for their pregnancy. So, for women, this was huge. But now with the Texas federal court ruling that the U.S. Preventive Services Task Force didn’t have any authority, it is a tremendous step backward.
We have culturally, linguistically appropriate standards in place, but it’s a matter in terms of how they’re carried out by state and by individual hospital systems. My wish list is that we really do listen to our patients, speak to them in a language of their choice, and provide them written materials in the language of their choice. We don’t fully do that.
Q: You mentioned one Texas ruling on the ACA. What’s your take on the ruling by another Texas judge suspending the abortion pill? And the U.S. Supreme Court’s overturning of Roe v. Wade?A. As a maternal-fetal medicine specialist who tries to help women plan for pregnancies, those rulings are a tremendous setback.
Q: And what about women of color? Will they find access to abortion services more difficult?
A. Oh, absolutely. When we speak of underrepresented minorities or those with less resources, they have less resources to then seek the appropriate care. Some women may have the opportunity to go to a different state or seek care elsewhere if their state doesn’t provide it. Many women just don’t have those resources to devote to them and don’t have a choice. So, we will see that disparity widen.
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
She’s seen progress, albeit slow, over three decades, yet the number of maternal deaths each year continues to rise.
Luckily, she’s got the ear of President Joe Biden’s health secretary.
Dr. Reyes, 64, is married to Health and Human Services Secretary Xavier Becerra, who is championing the administration’s initiative to require all states to provide Medicaid coverage to mothers for a year after giving birth. In March, the Centers for Disease Control and Prevention released data showing a 40% increase in U.S. maternal deaths from 2020 to 2021. The mortality rate among Black women was 2.6 times that of white women, no matter their economic status.
Over the years, Mr. Becerra has spoken highly of his wife’s expertise, but she downplays her influence, saying her husband of nearly 35 years “had it in him to begin with” to improve health care for women and to demand fewer pregnancy-related deaths. She, too, describes the nation’s high maternal mortality rate as unacceptable and preventable.
Dr. Reyes, a Latina who grew up as one of eight children in California’s agricultural heartland, now practices perinatology at the University of California, Davis. She is a member of a California Department of Public Health panel that reviews cases of maternal deaths and recommends improvements. And she chairs the board of the California Health Care Foundation, a nonprofit that works to increase health care access. (California Healthline is an editorially independent service of the California Health Care Foundation.)
Her work has been a blend of medicine and advocacy, and she worries recent federal court rulings will erode hard-fought victories regarding the safety of pregnant women and their babies. She discussed the nation’s maternal health crisis and health care disparities in an interview, which has been edited for length and clarity.
Question: When did you first realize there are disparities in the health care system?
Answer: When I was in high school in the Fresno Unified School District, we were under a consent decree to desegregate. And I was, at the time, student body president at Roosevelt High School. I was asked to be on this unified school district desegregation task force, where the district had to come up with a plan.
It was a time when I really had incredible exposure to how policies are made at a larger level, societal level, that really determine where people live, where they can seek health care, where they go to school. That experience had a tremendous impact on my life in terms of what I wanted to do in a career and how to give back.
Q: The U.S. has one of the best health care systems in the world, yet the maternal mortality rate is high compared with other developed countries. Why do think that is?
A. What we know by the CDC and maternal mortality review committees is that about 60% of maternal deaths are considered preventable. And that’s really been a lot of what I’ve tried to focus on: What can we do to reduce the severity of disease? Or what can we do within the role that we play in maternal health that can reduce that?
We know that there are societal issues absolutely that increase women’s risks and there are public health issues. But there’s a role that hospitals play in helping reduce that risk. Ten years ago, I was on the maternal mortality review committee for the state of California when we started reviewing cases of women who died within hospital systems to see, “Is there a role that we can play in a hospital system to reduce that risk?”
We recognized that sometimes there were conditions that were not recognized early enough so that there was a delay in the care. Sometimes there was a misdiagnosis. Or in some hospital systems, especially rural systems where there aren’t as many resources, sometimes there was the lack of specialists available. So, we’ve identified these risks and said, “We can do something about them.”
Q: You served on a federal panel 20 years ago that published a groundbreaking report identifying racism in health care. It seems as if we could be much further along.
A. The purpose of that committee was to really answer the question: Do patients receive a different level of care based on race? Looking back, we knew there was something there, but we really didn’t know. And it took months for the committee to come to that agreement, that there was a difference. I mean, that was honestly monumental, because we just didn’t have that level of consensus before. And so just to say “That treatment is unequal and it’s unacceptable” was really profound.
We thought that the 700-page report was going to be a time period where there was going to be tremendous movement, and I think I’ve learned over 20 years that change doesn’t happen quickly, especially when providers and health systems don’t see that they play a role. It’s like … “OK, so maybe it exists, but not for me.”
We all saw George Floyd and how he was treated. And during COVID we saw a tremendous difference in who was dying, right? Underrepresented minorities – certainly much higher. It was that culmination that made us realize the elephant in the room. We can’t ignore that this does exist, that there is a difference in how people are treated, even in our health care system.
Q: When addressing racism in health care, you talk about diversifying not just the health care workforce, but also the boardrooms of hospitals and health systems. Why is that important?
A. At the board level, change is hard. But we all play a role because leadership really helps determine much of what’s carried out. So, to have a leadership that is understanding and representative of the communities they serve, I think it has been demonstrated that we do make a difference.
Q: As a health care provider, do you have a wish list of policies you’d like the government to take up?
A. There was tremendous effort around offering preventive health services as a part of what was covered under the Affordable Care Act. And individuals exhaled, finally thinking this is a tremendous win, especially for women in pregnancy. Because we fought for preventive health services to help them have access so they can prepare for their pregnancy. So, for women, this was huge. But now with the Texas federal court ruling that the U.S. Preventive Services Task Force didn’t have any authority, it is a tremendous step backward.
We have culturally, linguistically appropriate standards in place, but it’s a matter in terms of how they’re carried out by state and by individual hospital systems. My wish list is that we really do listen to our patients, speak to them in a language of their choice, and provide them written materials in the language of their choice. We don’t fully do that.
Q: You mentioned one Texas ruling on the ACA. What’s your take on the ruling by another Texas judge suspending the abortion pill? And the U.S. Supreme Court’s overturning of Roe v. Wade?A. As a maternal-fetal medicine specialist who tries to help women plan for pregnancies, those rulings are a tremendous setback.
Q: And what about women of color? Will they find access to abortion services more difficult?
A. Oh, absolutely. When we speak of underrepresented minorities or those with less resources, they have less resources to then seek the appropriate care. Some women may have the opportunity to go to a different state or seek care elsewhere if their state doesn’t provide it. Many women just don’t have those resources to devote to them and don’t have a choice. So, we will see that disparity widen.
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
Remote weight monitoring minimizes office visits for newborns
WASHINGTON, D.C. – according to a new study presented at the Pediatric Academic Societies annual meeting.
The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.
Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.
The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers.
“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”
Keeping infants at home can also protect babies from infections they might catch in the clinic.
“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”
Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary.
The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration.
Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.
Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.
Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.
“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.
Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group.
The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
WASHINGTON, D.C. – according to a new study presented at the Pediatric Academic Societies annual meeting.
The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.
Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.
The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers.
“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”
Keeping infants at home can also protect babies from infections they might catch in the clinic.
“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”
Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary.
The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration.
Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.
Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.
Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.
“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.
Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group.
The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
WASHINGTON, D.C. – according to a new study presented at the Pediatric Academic Societies annual meeting.
The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.
Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.
The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers.
“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”
Keeping infants at home can also protect babies from infections they might catch in the clinic.
“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”
Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary.
The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration.
Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.
Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.
Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.
“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.
Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group.
The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT PAS 2023
Noisy incubators could stunt infant hearing
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SARS-CoV-2 crosses placenta and infects brains of two infants: ‘This is a first’
, according to a study published online today in Pediatrics .
One of the infants died at 13 months and the other remained in hospice care at time of manuscript submission.
Lead author Merline Benny, MD, with the division of neonatology, department of pediatrics at University of Miami, and colleagues briefed reporters today ahead of the release.
“This is a first,” said senior author Shahnaz Duara, MD, medical director of the Neonatal Intensive Care Unit at Holtz Children’s Hospital, Miami, explaining it is the first study to confirm cross-placental SARS-CoV-2 transmission leading to brain injury in a newborn.
Both infants negative for the virus at birth
The two infants were admitted in the early days of the pandemic in the Delta wave to the neonatal ICU at Holtz Children’s Hospital at University of Miami/Jackson Memorial Medical Center.
Both infants tested negative for the virus at birth, but had significantly elevated SARS-CoV-2 antibodies in their blood, indicating that either antibodies crossed the placenta, or the virus crossed and the immune response was the baby’s.
Dr. Benny explained that the researchers have seen, to this point, more than 700 mother/infant pairs in whom the mother tested positive for COVID in Jackson hospital.
Most who tested positive for COVID were asymptomatic and most of the mothers and infants left the hospital without complications.
“However, (these) two babies had a very unusual clinical picture,” Dr. Benny said.
Those infants were born to mothers who became COVID positive in the second trimester and delivered a few weeks later.
Seizures started on day 1 of life
The babies began to seize from the first day of life. They had profound low tone (hypotonia) in their clinical exam, Dr. Benny explained.
“We had absolutely no good explanation for the early seizures and the degree of brain injury we saw,” Dr. Duara said.
Dr. Benny said that as their bodies grew, they had very small head circumference. Unlike some babies born with the Zika virus, these babies were not microcephalic at birth. Brain imaging on the two babies indicated significant brain atrophy, and neurodevelopment exams showed significant delay.
Discussions began with the center’s multidisciplinary team including neurologists, pathologists, neuroradiologists, and obstetricians who cared for both the mothers and the babies.
The experts examined the placentas and found some characteristic COVID changes and presence of the COVID virus. This was accompanied by increased markers for inflammation and a severe reduction in a hormone critical for placental health and brain development.
Examining the infant’s autopsy findings further raised suspicions of maternal transmission, something that had not been documented before.
Coauthor Ali G. Saad, MD, pediatric and perinatal pathology director at Miami, said, “I have seen literally thousands of brains in autopsies over the last 14 years, and this was the most dramatic case of leukoencephalopathy or loss of white matter in a patient with no significant reason. That’s what triggered the investigation.”
Mothers had very different presentations
Coauthor Michael J. Paidas, MD, with the department of obstetrics, gynecology, and reproductive sciences at Miami, pointed out that the circumstances of the two mothers, who were in their 20s, were very different.
One mother delivered at 32 weeks and had a very severe COVID presentation and spent a month in the intensive care unit. The team decided to deliver the child to save the mother, Dr. Paidas said.
In contrast, the other mother had asymptomatic COVID infection in the second trimester and delivered at full term.
He said one of the early suspicions in the babies’ presentations was hypoxic ischemic encephalopathy. “But it wasn’t lack of blood flow to the placenta that caused this,” he said. “As best we can tell, it was the viral infection.”
Instances are rare
The researchers emphasized that these instances are rare and have not been seen before or since the period of this study to their knowledge.
Dr. Duara said, “This is something we want to alert the medical community to more than the general public. We do not want the lay public to be panicked. We’re trying to understand what made these two pregnancies different, so we can direct research towards protecting vulnerable babies.”
Previous data have indicated a relatively benign status in infants who test negative for the COVID virus after birth. Dr. Benny added that COVID vaccination has been found safe in pregnancy and both vaccination and breastfeeding can help passage of antibodies to the infant and help protect the baby. Because these cases happened in the early days of the pandemic, no vaccines were available.
Dr. Paidas received funding from BioIncept to study hypoxic-ischemic encephalopathy with Preimplantation Factor, is a scientific advisory board member, and has stock options. Dr. Paidas and coauthor Dr. Jayakumar are coinventors of SPIKENET, University of Miami, patent pending 2023. The other authors have no conflicts of interest to disclose.
, according to a study published online today in Pediatrics .
One of the infants died at 13 months and the other remained in hospice care at time of manuscript submission.
Lead author Merline Benny, MD, with the division of neonatology, department of pediatrics at University of Miami, and colleagues briefed reporters today ahead of the release.
“This is a first,” said senior author Shahnaz Duara, MD, medical director of the Neonatal Intensive Care Unit at Holtz Children’s Hospital, Miami, explaining it is the first study to confirm cross-placental SARS-CoV-2 transmission leading to brain injury in a newborn.
Both infants negative for the virus at birth
The two infants were admitted in the early days of the pandemic in the Delta wave to the neonatal ICU at Holtz Children’s Hospital at University of Miami/Jackson Memorial Medical Center.
Both infants tested negative for the virus at birth, but had significantly elevated SARS-CoV-2 antibodies in their blood, indicating that either antibodies crossed the placenta, or the virus crossed and the immune response was the baby’s.
Dr. Benny explained that the researchers have seen, to this point, more than 700 mother/infant pairs in whom the mother tested positive for COVID in Jackson hospital.
Most who tested positive for COVID were asymptomatic and most of the mothers and infants left the hospital without complications.
“However, (these) two babies had a very unusual clinical picture,” Dr. Benny said.
Those infants were born to mothers who became COVID positive in the second trimester and delivered a few weeks later.
Seizures started on day 1 of life
The babies began to seize from the first day of life. They had profound low tone (hypotonia) in their clinical exam, Dr. Benny explained.
“We had absolutely no good explanation for the early seizures and the degree of brain injury we saw,” Dr. Duara said.
Dr. Benny said that as their bodies grew, they had very small head circumference. Unlike some babies born with the Zika virus, these babies were not microcephalic at birth. Brain imaging on the two babies indicated significant brain atrophy, and neurodevelopment exams showed significant delay.
Discussions began with the center’s multidisciplinary team including neurologists, pathologists, neuroradiologists, and obstetricians who cared for both the mothers and the babies.
The experts examined the placentas and found some characteristic COVID changes and presence of the COVID virus. This was accompanied by increased markers for inflammation and a severe reduction in a hormone critical for placental health and brain development.
Examining the infant’s autopsy findings further raised suspicions of maternal transmission, something that had not been documented before.
Coauthor Ali G. Saad, MD, pediatric and perinatal pathology director at Miami, said, “I have seen literally thousands of brains in autopsies over the last 14 years, and this was the most dramatic case of leukoencephalopathy or loss of white matter in a patient with no significant reason. That’s what triggered the investigation.”
Mothers had very different presentations
Coauthor Michael J. Paidas, MD, with the department of obstetrics, gynecology, and reproductive sciences at Miami, pointed out that the circumstances of the two mothers, who were in their 20s, were very different.
One mother delivered at 32 weeks and had a very severe COVID presentation and spent a month in the intensive care unit. The team decided to deliver the child to save the mother, Dr. Paidas said.
In contrast, the other mother had asymptomatic COVID infection in the second trimester and delivered at full term.
He said one of the early suspicions in the babies’ presentations was hypoxic ischemic encephalopathy. “But it wasn’t lack of blood flow to the placenta that caused this,” he said. “As best we can tell, it was the viral infection.”
Instances are rare
The researchers emphasized that these instances are rare and have not been seen before or since the period of this study to their knowledge.
Dr. Duara said, “This is something we want to alert the medical community to more than the general public. We do not want the lay public to be panicked. We’re trying to understand what made these two pregnancies different, so we can direct research towards protecting vulnerable babies.”
Previous data have indicated a relatively benign status in infants who test negative for the COVID virus after birth. Dr. Benny added that COVID vaccination has been found safe in pregnancy and both vaccination and breastfeeding can help passage of antibodies to the infant and help protect the baby. Because these cases happened in the early days of the pandemic, no vaccines were available.
Dr. Paidas received funding from BioIncept to study hypoxic-ischemic encephalopathy with Preimplantation Factor, is a scientific advisory board member, and has stock options. Dr. Paidas and coauthor Dr. Jayakumar are coinventors of SPIKENET, University of Miami, patent pending 2023. The other authors have no conflicts of interest to disclose.
, according to a study published online today in Pediatrics .
One of the infants died at 13 months and the other remained in hospice care at time of manuscript submission.
Lead author Merline Benny, MD, with the division of neonatology, department of pediatrics at University of Miami, and colleagues briefed reporters today ahead of the release.
“This is a first,” said senior author Shahnaz Duara, MD, medical director of the Neonatal Intensive Care Unit at Holtz Children’s Hospital, Miami, explaining it is the first study to confirm cross-placental SARS-CoV-2 transmission leading to brain injury in a newborn.
Both infants negative for the virus at birth
The two infants were admitted in the early days of the pandemic in the Delta wave to the neonatal ICU at Holtz Children’s Hospital at University of Miami/Jackson Memorial Medical Center.
Both infants tested negative for the virus at birth, but had significantly elevated SARS-CoV-2 antibodies in their blood, indicating that either antibodies crossed the placenta, or the virus crossed and the immune response was the baby’s.
Dr. Benny explained that the researchers have seen, to this point, more than 700 mother/infant pairs in whom the mother tested positive for COVID in Jackson hospital.
Most who tested positive for COVID were asymptomatic and most of the mothers and infants left the hospital without complications.
“However, (these) two babies had a very unusual clinical picture,” Dr. Benny said.
Those infants were born to mothers who became COVID positive in the second trimester and delivered a few weeks later.
Seizures started on day 1 of life
The babies began to seize from the first day of life. They had profound low tone (hypotonia) in their clinical exam, Dr. Benny explained.
“We had absolutely no good explanation for the early seizures and the degree of brain injury we saw,” Dr. Duara said.
Dr. Benny said that as their bodies grew, they had very small head circumference. Unlike some babies born with the Zika virus, these babies were not microcephalic at birth. Brain imaging on the two babies indicated significant brain atrophy, and neurodevelopment exams showed significant delay.
Discussions began with the center’s multidisciplinary team including neurologists, pathologists, neuroradiologists, and obstetricians who cared for both the mothers and the babies.
The experts examined the placentas and found some characteristic COVID changes and presence of the COVID virus. This was accompanied by increased markers for inflammation and a severe reduction in a hormone critical for placental health and brain development.
Examining the infant’s autopsy findings further raised suspicions of maternal transmission, something that had not been documented before.
Coauthor Ali G. Saad, MD, pediatric and perinatal pathology director at Miami, said, “I have seen literally thousands of brains in autopsies over the last 14 years, and this was the most dramatic case of leukoencephalopathy or loss of white matter in a patient with no significant reason. That’s what triggered the investigation.”
Mothers had very different presentations
Coauthor Michael J. Paidas, MD, with the department of obstetrics, gynecology, and reproductive sciences at Miami, pointed out that the circumstances of the two mothers, who were in their 20s, were very different.
One mother delivered at 32 weeks and had a very severe COVID presentation and spent a month in the intensive care unit. The team decided to deliver the child to save the mother, Dr. Paidas said.
In contrast, the other mother had asymptomatic COVID infection in the second trimester and delivered at full term.
He said one of the early suspicions in the babies’ presentations was hypoxic ischemic encephalopathy. “But it wasn’t lack of blood flow to the placenta that caused this,” he said. “As best we can tell, it was the viral infection.”
Instances are rare
The researchers emphasized that these instances are rare and have not been seen before or since the period of this study to their knowledge.
Dr. Duara said, “This is something we want to alert the medical community to more than the general public. We do not want the lay public to be panicked. We’re trying to understand what made these two pregnancies different, so we can direct research towards protecting vulnerable babies.”
Previous data have indicated a relatively benign status in infants who test negative for the COVID virus after birth. Dr. Benny added that COVID vaccination has been found safe in pregnancy and both vaccination and breastfeeding can help passage of antibodies to the infant and help protect the baby. Because these cases happened in the early days of the pandemic, no vaccines were available.
Dr. Paidas received funding from BioIncept to study hypoxic-ischemic encephalopathy with Preimplantation Factor, is a scientific advisory board member, and has stock options. Dr. Paidas and coauthor Dr. Jayakumar are coinventors of SPIKENET, University of Miami, patent pending 2023. The other authors have no conflicts of interest to disclose.
FROM PEDIATRICS
Sleep duration of Black infants increased by intervention
An intervention tailored for Black first-time mothers helped increase their infants’ sleep time, researchers have found, a notable result as many studies have shown Black infants get less sleep on average than White infants.
Less sleep has historically put Black children at higher risk for negative outcomes including obesity and poorer social-emotional functioning and cognitive development. These disparities persist into adulthood, the researchers note, as previous studies have shown.
Justin A. Lavner, PhD, with the department of psychology at the University of Georgia in Athens, led this post hoc secondary analysis of the Sleep SAAF (Strong African American Families) study, a randomized clinical trial of 234 participants comparing a responsive parenting (RP) intervention with a safety control group over the first 16 weeks post partum. The original analysis studied the effects of the intervention on rapid weight gain.
In the original analysis, the authors write that “From birth to 2, the prevalence of high weight for length (above the 95th percentile) is 25% higher among African American children compared to White children. From age 2 to 19, the rate of obesity is more than 50% higher among African American children compared to White children. Similar disparities persist into adulthood: rates of obesity are approximately 25% higher among African American adults compared to White adults.”
The differences in early rapid weight gain may be driving the disparities, the authors write.
Elements of the intervention
The intervention in the current analysis included materials delivered at the 3- and 8-week home visits focused on soothing and crying, feeding, and interactive play in the babies’ first months. Families were recruited from Augusta University Medical Center in Augusta, Ga., and had home visits at 1, 3, 8, and 16 weeks post partum.
Mothers got a packet of handouts and facilitators walked through the information with them. The measures involved hands-on activities, discussion, and videos, all tailored for Black families, the authors state.
Mothers were taught about responding appropriately at night when their baby cries, including giving the baby a couple of minutes to fall back to sleep independently and by using calming messages, such as shushing or white noise, before picking the baby up.
Babies learn to fall asleep on their own
They also learned to put infants to bed early (ideally by 8 p.m.) so the babies would be calm but awake and could learn to fall asleep on their own.
The control group’s guidance was matched for intensity and session length but focused on sleep and home safety, such as reducing the risk of sudden infant death syndrome (SIDS), keeping the baby’s sleep area close to, but away from, the mother’s bed, and preventing shaken baby syndrome.
In both groups, the 3-week visit session lasted about 90-120 minutes and the 8-week visit lasted about 45-60 minutes.
Longer sleep with the intervention
A total of 212 Black mothers, average age 22.7, were randomized – 108 to the RP group and 104 to the control group. Answers on questionnaires were analyzed and at 16 weeks post partum, infants in the RP group (relative to controls) had:
- Longer reported nighttime sleep (mean difference, 40 minutes [95% confidence interval, 3-77]).
- Longer total sleep duration (mean difference, 73 minutes [95% CI, 14-131]).
- Fewer nighttime wakings (mean difference, −0.4 wakings [95% CI, −0.6 to −0.1]).
- Greater likelihood of meeting guidelines of at least 12 hours of sleep per day (risk ratio, 1.4 [95% CI, 1.1 to 1.8]) than controls.
Findings were published in JAMA Network Open.
Additionally, mothers in the RP group more frequently reported they engaged in practices such as letting babies have a few minutes to fall back to sleep on their own (RR, 1.6 [95% CI, 1.0-2.6]) and being less likely to feed their infant just before the baby’s bedtime (RR, 0.5 [95% CI, 0.3-0.8]).
In an accompanying invited commentary, Sarah M. Honaker, PhD, department of pediatrics, Indiana University, Indianapolis, and Alicia Chung, EdD, Center for Early Childhood Health and Development at New York University, write that though the added average sleep duration is one of the most significant findings, there is a possibility of desirability bias because it was reported by the mothers after specific guidance by the facilitators.
“Nonetheless,” the editorialists write, “even if the true effect were half as small, this additional sleep duration could yield notable benefits in infant development if the effect persisted over time. The difference in night wakings between the intervention and control groups (1.8 vs 1.5 per night) at 16 weeks postpartum was statistically significant, though it is unclear whether this difference is clinically meaningful to families.”
They note that it is unclear from the study how the intervention was culturally adapted and how the adaptation might have affected outcomes.
Sleep intervention trials have focused on White families
The editorialists write that much is known about the benefits of behavioral sleep intervention in controlled trials and general population settings, and no adverse effects on infant attachment or cortisol levels have been linked to the interventions.
However, they add, “Unfortunately, this substantial progress in our understanding of infant BSI [behavioral sleep intervention] comes with a caveat, in that most previous studies have been performed with White families from mid-to-high socioeconomic backgrounds.”
Dr. Honaker and Dr. Chung write, “[I]t is important to note that much work remains to examine the acceptability, feasibility, and efficacy of infant BSI in other groups that have been historically marginalized.”
Dr. Lavner and colleagues point out that before their study, there had been little emphasis on interventions to encourage better sleep in general for Black infants, “as most early sleep interventions for this population have focused on SIDS prevention.”
“To our knowledge, Sleep SAAF is the first study to show any benefits of [an] RP intervention on sleep and sleep practices among Black infants and their families,” they write.
The researchers note that a limitation of the study is that the study sample was limited to Black first-time mothers recruited from a single medical center in Georgia.
The study by Dr. Lavner et al. was funded by the National Institutes of Health, a Harrington Faculty Fellowship from the University of Texas, and an award from the Penn State Clinical and Translational Sciences Institute supported by the National Center for Advancing Translational Sciences. Editorialist Dr. Honaker reported receiving grants from Nationwide Children’s Hospital (parent grant, Centers for Disease Control and Prevention) to evaluate the acceptability of infant behavioral sleep intervention in Black families.
An intervention tailored for Black first-time mothers helped increase their infants’ sleep time, researchers have found, a notable result as many studies have shown Black infants get less sleep on average than White infants.
Less sleep has historically put Black children at higher risk for negative outcomes including obesity and poorer social-emotional functioning and cognitive development. These disparities persist into adulthood, the researchers note, as previous studies have shown.
Justin A. Lavner, PhD, with the department of psychology at the University of Georgia in Athens, led this post hoc secondary analysis of the Sleep SAAF (Strong African American Families) study, a randomized clinical trial of 234 participants comparing a responsive parenting (RP) intervention with a safety control group over the first 16 weeks post partum. The original analysis studied the effects of the intervention on rapid weight gain.
In the original analysis, the authors write that “From birth to 2, the prevalence of high weight for length (above the 95th percentile) is 25% higher among African American children compared to White children. From age 2 to 19, the rate of obesity is more than 50% higher among African American children compared to White children. Similar disparities persist into adulthood: rates of obesity are approximately 25% higher among African American adults compared to White adults.”
The differences in early rapid weight gain may be driving the disparities, the authors write.
Elements of the intervention
The intervention in the current analysis included materials delivered at the 3- and 8-week home visits focused on soothing and crying, feeding, and interactive play in the babies’ first months. Families were recruited from Augusta University Medical Center in Augusta, Ga., and had home visits at 1, 3, 8, and 16 weeks post partum.
Mothers got a packet of handouts and facilitators walked through the information with them. The measures involved hands-on activities, discussion, and videos, all tailored for Black families, the authors state.
Mothers were taught about responding appropriately at night when their baby cries, including giving the baby a couple of minutes to fall back to sleep independently and by using calming messages, such as shushing or white noise, before picking the baby up.
Babies learn to fall asleep on their own
They also learned to put infants to bed early (ideally by 8 p.m.) so the babies would be calm but awake and could learn to fall asleep on their own.
The control group’s guidance was matched for intensity and session length but focused on sleep and home safety, such as reducing the risk of sudden infant death syndrome (SIDS), keeping the baby’s sleep area close to, but away from, the mother’s bed, and preventing shaken baby syndrome.
In both groups, the 3-week visit session lasted about 90-120 minutes and the 8-week visit lasted about 45-60 minutes.
Longer sleep with the intervention
A total of 212 Black mothers, average age 22.7, were randomized – 108 to the RP group and 104 to the control group. Answers on questionnaires were analyzed and at 16 weeks post partum, infants in the RP group (relative to controls) had:
- Longer reported nighttime sleep (mean difference, 40 minutes [95% confidence interval, 3-77]).
- Longer total sleep duration (mean difference, 73 minutes [95% CI, 14-131]).
- Fewer nighttime wakings (mean difference, −0.4 wakings [95% CI, −0.6 to −0.1]).
- Greater likelihood of meeting guidelines of at least 12 hours of sleep per day (risk ratio, 1.4 [95% CI, 1.1 to 1.8]) than controls.
Findings were published in JAMA Network Open.
Additionally, mothers in the RP group more frequently reported they engaged in practices such as letting babies have a few minutes to fall back to sleep on their own (RR, 1.6 [95% CI, 1.0-2.6]) and being less likely to feed their infant just before the baby’s bedtime (RR, 0.5 [95% CI, 0.3-0.8]).
In an accompanying invited commentary, Sarah M. Honaker, PhD, department of pediatrics, Indiana University, Indianapolis, and Alicia Chung, EdD, Center for Early Childhood Health and Development at New York University, write that though the added average sleep duration is one of the most significant findings, there is a possibility of desirability bias because it was reported by the mothers after specific guidance by the facilitators.
“Nonetheless,” the editorialists write, “even if the true effect were half as small, this additional sleep duration could yield notable benefits in infant development if the effect persisted over time. The difference in night wakings between the intervention and control groups (1.8 vs 1.5 per night) at 16 weeks postpartum was statistically significant, though it is unclear whether this difference is clinically meaningful to families.”
They note that it is unclear from the study how the intervention was culturally adapted and how the adaptation might have affected outcomes.
Sleep intervention trials have focused on White families
The editorialists write that much is known about the benefits of behavioral sleep intervention in controlled trials and general population settings, and no adverse effects on infant attachment or cortisol levels have been linked to the interventions.
However, they add, “Unfortunately, this substantial progress in our understanding of infant BSI [behavioral sleep intervention] comes with a caveat, in that most previous studies have been performed with White families from mid-to-high socioeconomic backgrounds.”
Dr. Honaker and Dr. Chung write, “[I]t is important to note that much work remains to examine the acceptability, feasibility, and efficacy of infant BSI in other groups that have been historically marginalized.”
Dr. Lavner and colleagues point out that before their study, there had been little emphasis on interventions to encourage better sleep in general for Black infants, “as most early sleep interventions for this population have focused on SIDS prevention.”
“To our knowledge, Sleep SAAF is the first study to show any benefits of [an] RP intervention on sleep and sleep practices among Black infants and their families,” they write.
The researchers note that a limitation of the study is that the study sample was limited to Black first-time mothers recruited from a single medical center in Georgia.
The study by Dr. Lavner et al. was funded by the National Institutes of Health, a Harrington Faculty Fellowship from the University of Texas, and an award from the Penn State Clinical and Translational Sciences Institute supported by the National Center for Advancing Translational Sciences. Editorialist Dr. Honaker reported receiving grants from Nationwide Children’s Hospital (parent grant, Centers for Disease Control and Prevention) to evaluate the acceptability of infant behavioral sleep intervention in Black families.
An intervention tailored for Black first-time mothers helped increase their infants’ sleep time, researchers have found, a notable result as many studies have shown Black infants get less sleep on average than White infants.
Less sleep has historically put Black children at higher risk for negative outcomes including obesity and poorer social-emotional functioning and cognitive development. These disparities persist into adulthood, the researchers note, as previous studies have shown.
Justin A. Lavner, PhD, with the department of psychology at the University of Georgia in Athens, led this post hoc secondary analysis of the Sleep SAAF (Strong African American Families) study, a randomized clinical trial of 234 participants comparing a responsive parenting (RP) intervention with a safety control group over the first 16 weeks post partum. The original analysis studied the effects of the intervention on rapid weight gain.
In the original analysis, the authors write that “From birth to 2, the prevalence of high weight for length (above the 95th percentile) is 25% higher among African American children compared to White children. From age 2 to 19, the rate of obesity is more than 50% higher among African American children compared to White children. Similar disparities persist into adulthood: rates of obesity are approximately 25% higher among African American adults compared to White adults.”
The differences in early rapid weight gain may be driving the disparities, the authors write.
Elements of the intervention
The intervention in the current analysis included materials delivered at the 3- and 8-week home visits focused on soothing and crying, feeding, and interactive play in the babies’ first months. Families were recruited from Augusta University Medical Center in Augusta, Ga., and had home visits at 1, 3, 8, and 16 weeks post partum.
Mothers got a packet of handouts and facilitators walked through the information with them. The measures involved hands-on activities, discussion, and videos, all tailored for Black families, the authors state.
Mothers were taught about responding appropriately at night when their baby cries, including giving the baby a couple of minutes to fall back to sleep independently and by using calming messages, such as shushing or white noise, before picking the baby up.
Babies learn to fall asleep on their own
They also learned to put infants to bed early (ideally by 8 p.m.) so the babies would be calm but awake and could learn to fall asleep on their own.
The control group’s guidance was matched for intensity and session length but focused on sleep and home safety, such as reducing the risk of sudden infant death syndrome (SIDS), keeping the baby’s sleep area close to, but away from, the mother’s bed, and preventing shaken baby syndrome.
In both groups, the 3-week visit session lasted about 90-120 minutes and the 8-week visit lasted about 45-60 minutes.
Longer sleep with the intervention
A total of 212 Black mothers, average age 22.7, were randomized – 108 to the RP group and 104 to the control group. Answers on questionnaires were analyzed and at 16 weeks post partum, infants in the RP group (relative to controls) had:
- Longer reported nighttime sleep (mean difference, 40 minutes [95% confidence interval, 3-77]).
- Longer total sleep duration (mean difference, 73 minutes [95% CI, 14-131]).
- Fewer nighttime wakings (mean difference, −0.4 wakings [95% CI, −0.6 to −0.1]).
- Greater likelihood of meeting guidelines of at least 12 hours of sleep per day (risk ratio, 1.4 [95% CI, 1.1 to 1.8]) than controls.
Findings were published in JAMA Network Open.
Additionally, mothers in the RP group more frequently reported they engaged in practices such as letting babies have a few minutes to fall back to sleep on their own (RR, 1.6 [95% CI, 1.0-2.6]) and being less likely to feed their infant just before the baby’s bedtime (RR, 0.5 [95% CI, 0.3-0.8]).
In an accompanying invited commentary, Sarah M. Honaker, PhD, department of pediatrics, Indiana University, Indianapolis, and Alicia Chung, EdD, Center for Early Childhood Health and Development at New York University, write that though the added average sleep duration is one of the most significant findings, there is a possibility of desirability bias because it was reported by the mothers after specific guidance by the facilitators.
“Nonetheless,” the editorialists write, “even if the true effect were half as small, this additional sleep duration could yield notable benefits in infant development if the effect persisted over time. The difference in night wakings between the intervention and control groups (1.8 vs 1.5 per night) at 16 weeks postpartum was statistically significant, though it is unclear whether this difference is clinically meaningful to families.”
They note that it is unclear from the study how the intervention was culturally adapted and how the adaptation might have affected outcomes.
Sleep intervention trials have focused on White families
The editorialists write that much is known about the benefits of behavioral sleep intervention in controlled trials and general population settings, and no adverse effects on infant attachment or cortisol levels have been linked to the interventions.
However, they add, “Unfortunately, this substantial progress in our understanding of infant BSI [behavioral sleep intervention] comes with a caveat, in that most previous studies have been performed with White families from mid-to-high socioeconomic backgrounds.”
Dr. Honaker and Dr. Chung write, “[I]t is important to note that much work remains to examine the acceptability, feasibility, and efficacy of infant BSI in other groups that have been historically marginalized.”
Dr. Lavner and colleagues point out that before their study, there had been little emphasis on interventions to encourage better sleep in general for Black infants, “as most early sleep interventions for this population have focused on SIDS prevention.”
“To our knowledge, Sleep SAAF is the first study to show any benefits of [an] RP intervention on sleep and sleep practices among Black infants and their families,” they write.
The researchers note that a limitation of the study is that the study sample was limited to Black first-time mothers recruited from a single medical center in Georgia.
The study by Dr. Lavner et al. was funded by the National Institutes of Health, a Harrington Faculty Fellowship from the University of Texas, and an award from the Penn State Clinical and Translational Sciences Institute supported by the National Center for Advancing Translational Sciences. Editorialist Dr. Honaker reported receiving grants from Nationwide Children’s Hospital (parent grant, Centers for Disease Control and Prevention) to evaluate the acceptability of infant behavioral sleep intervention in Black families.
FROM JAMA NETWORK OPEN
Neonatal bilirubin meters need better accuracy
Despite their convenience and low cost, , a systematic review and meta-analysis reports in JAMA Pediatrics. Lauren E.H. Westenberg, MD, of the division of neonatology at Erasmus MC Sophia Children’s Hospital in Rotterdam, the Netherlands, and colleagues reported that POC meters tended to underestimate neonatal bilirubin levels, compared with conventional laboratory-based quantification.
Furthermore, pooled estimates from 10 studies found these devices to be too imprecise overall, with substantial outer-confidence bounds. On the plus side, Dr. Westenberg’s group said POC bilirubin testing was as much as 60 times faster than lab measurement, and used 40-60 times less blood. “Conventional laboratory-based bilirubin quantification usually requires up to 500 mcL, but sometimes even 1,500 mcL, while POC tests require up to 50 mcL, which means less stress for the baby,” Dr. Westenberg said in an interview. “Especially when infants are cared for at home, it usually takes a few hours between deciding to quantify bilirubin and obtaining the test result. Meanwhile, bilirubin levels may rise unnoticed.”
On the positive side, POC devices are useful where laboratories in low-resource areas may be remote, poorly equipped, and not always able to provide an accurate bilirubin level. “As a result, the diagnosis of jaundice relies mainly on visual inspection, which is known to be unreliable,” she said. POC devices, however, need near-perfect conditions for optimal use, and results can be affected by humidity, preanalytic conditions such as test strip saturation, and hematocrit.
Yet results from these devices have recently proven to have acceptable accuracy, resulting, for example, in the same clinical decisions as the reference standard in 90.7% of times according to a 2022 study in a hospital in Malawi.
Nevertheless, the authors concluded that the devices’ imprecision limits their widespread use in neonatal jaundice management, especially when accurate lab-based bilirubin quantification is available. Results from these POC tests should be interpreted with caution, Dr. Westenberg said. In terms of clinical decision-making, POC devices entail a risk of missing neonates with jaundice who need phototherapy or, in the case of overestimation, of starting phototherapy too early.
The study
The meta-analysis included nine cross-sectional and one prospective cohort study representing 3,122 neonates in Europe, Africa, and East and Southeast Asia. Two tests with 30-minute turnaround times were evaluated in neonates 0-28 days old. The Bilistick device was evaluated in eight studies and the BiliSpec (now called BiliDX) in just two studies. Three of the studies had a high risk of bias.
A total of 3,122 measurements paired with lab quantification showed a pooled mean difference in total bilirubin levels for the POC devices of –14 micromol/L, with pooled 95% confidence bounds (CBs) of –106 to 78 micromol/L. For the Bilistick, the pooled mean difference was –17 micromol/L (95% CBs, –114 to 80 micromol/L). Of the two devices, the Bilistick was more likely to have a failed quantification against the reference standard.
Context for POC devices
Commenting on the meta-analysis but not involved in it, Rebecca Richards-Kortum, PhD, a professor of biomedical engineering at Rice University in Houston, noted that both devices were developed specifically to address needs in low-resource settings. “I don’t think the meta-analysis acknowledges this rationale sufficiently,” she said. “It feels like this paper is comparing apples to oranges and then criticizing the apples for not being oranges,” said Dr. Richards-Kortum, who helped develop the BiliSpec test.
Similarly, Anne S. Lee, MD, MPH, an associate professor of pediatrics at Brigham and Women’s Hospital in Boston, and not a participant in the meta-analysis, also stressed that POC devices are designed for scenarios where lab-based results are not widely available. “In a broad sense, the devices fill an important gap, both in low- and middle-income countries, as well as in the U.S. when laboratory capacity is not readily available,” said Dr. Lee. She was involved the development of the Bili-ruler icterometer, which proved to be diagnostically accurate in Bangladeshi newborns.
“Access to this technology is a critical way to address health disparities even in the U.S.,” Dr. Lee continued. “We have heard of the need for this technology from the Indian health services and Alaskan health services, where decisions are made to airlift a child based on a visual inspection alone.”
More broadly, however, cautioned Dr. Westenberg, the total allowable error and the permissible limits of uncertainty in neonatal bilirubin quantification need to be defined – irrespective of the method used. “Accurate measurement of bilirubin is difficult as has been demonstrated in so-called external quality assessment (EQA) programs that exist for laboratory-based bilirubin methods,” she said. “EQA programs for POC bilirubin devices that include a reference method as a gold standard may contribute to adaptation of the device and improving POC test imprecision.”
This work was supported by the Netherlands Organization for Health Research and Development. The authors had no conflicts of interest to disclose. Dr. Richards-Kortum and Dr. Lee have both been involved in the development of POC devices for assessing neonatal bilirubin levels.
Despite their convenience and low cost, , a systematic review and meta-analysis reports in JAMA Pediatrics. Lauren E.H. Westenberg, MD, of the division of neonatology at Erasmus MC Sophia Children’s Hospital in Rotterdam, the Netherlands, and colleagues reported that POC meters tended to underestimate neonatal bilirubin levels, compared with conventional laboratory-based quantification.
Furthermore, pooled estimates from 10 studies found these devices to be too imprecise overall, with substantial outer-confidence bounds. On the plus side, Dr. Westenberg’s group said POC bilirubin testing was as much as 60 times faster than lab measurement, and used 40-60 times less blood. “Conventional laboratory-based bilirubin quantification usually requires up to 500 mcL, but sometimes even 1,500 mcL, while POC tests require up to 50 mcL, which means less stress for the baby,” Dr. Westenberg said in an interview. “Especially when infants are cared for at home, it usually takes a few hours between deciding to quantify bilirubin and obtaining the test result. Meanwhile, bilirubin levels may rise unnoticed.”
On the positive side, POC devices are useful where laboratories in low-resource areas may be remote, poorly equipped, and not always able to provide an accurate bilirubin level. “As a result, the diagnosis of jaundice relies mainly on visual inspection, which is known to be unreliable,” she said. POC devices, however, need near-perfect conditions for optimal use, and results can be affected by humidity, preanalytic conditions such as test strip saturation, and hematocrit.
Yet results from these devices have recently proven to have acceptable accuracy, resulting, for example, in the same clinical decisions as the reference standard in 90.7% of times according to a 2022 study in a hospital in Malawi.
Nevertheless, the authors concluded that the devices’ imprecision limits their widespread use in neonatal jaundice management, especially when accurate lab-based bilirubin quantification is available. Results from these POC tests should be interpreted with caution, Dr. Westenberg said. In terms of clinical decision-making, POC devices entail a risk of missing neonates with jaundice who need phototherapy or, in the case of overestimation, of starting phototherapy too early.
The study
The meta-analysis included nine cross-sectional and one prospective cohort study representing 3,122 neonates in Europe, Africa, and East and Southeast Asia. Two tests with 30-minute turnaround times were evaluated in neonates 0-28 days old. The Bilistick device was evaluated in eight studies and the BiliSpec (now called BiliDX) in just two studies. Three of the studies had a high risk of bias.
A total of 3,122 measurements paired with lab quantification showed a pooled mean difference in total bilirubin levels for the POC devices of –14 micromol/L, with pooled 95% confidence bounds (CBs) of –106 to 78 micromol/L. For the Bilistick, the pooled mean difference was –17 micromol/L (95% CBs, –114 to 80 micromol/L). Of the two devices, the Bilistick was more likely to have a failed quantification against the reference standard.
Context for POC devices
Commenting on the meta-analysis but not involved in it, Rebecca Richards-Kortum, PhD, a professor of biomedical engineering at Rice University in Houston, noted that both devices were developed specifically to address needs in low-resource settings. “I don’t think the meta-analysis acknowledges this rationale sufficiently,” she said. “It feels like this paper is comparing apples to oranges and then criticizing the apples for not being oranges,” said Dr. Richards-Kortum, who helped develop the BiliSpec test.
Similarly, Anne S. Lee, MD, MPH, an associate professor of pediatrics at Brigham and Women’s Hospital in Boston, and not a participant in the meta-analysis, also stressed that POC devices are designed for scenarios where lab-based results are not widely available. “In a broad sense, the devices fill an important gap, both in low- and middle-income countries, as well as in the U.S. when laboratory capacity is not readily available,” said Dr. Lee. She was involved the development of the Bili-ruler icterometer, which proved to be diagnostically accurate in Bangladeshi newborns.
“Access to this technology is a critical way to address health disparities even in the U.S.,” Dr. Lee continued. “We have heard of the need for this technology from the Indian health services and Alaskan health services, where decisions are made to airlift a child based on a visual inspection alone.”
More broadly, however, cautioned Dr. Westenberg, the total allowable error and the permissible limits of uncertainty in neonatal bilirubin quantification need to be defined – irrespective of the method used. “Accurate measurement of bilirubin is difficult as has been demonstrated in so-called external quality assessment (EQA) programs that exist for laboratory-based bilirubin methods,” she said. “EQA programs for POC bilirubin devices that include a reference method as a gold standard may contribute to adaptation of the device and improving POC test imprecision.”
This work was supported by the Netherlands Organization for Health Research and Development. The authors had no conflicts of interest to disclose. Dr. Richards-Kortum and Dr. Lee have both been involved in the development of POC devices for assessing neonatal bilirubin levels.
Despite their convenience and low cost, , a systematic review and meta-analysis reports in JAMA Pediatrics. Lauren E.H. Westenberg, MD, of the division of neonatology at Erasmus MC Sophia Children’s Hospital in Rotterdam, the Netherlands, and colleagues reported that POC meters tended to underestimate neonatal bilirubin levels, compared with conventional laboratory-based quantification.
Furthermore, pooled estimates from 10 studies found these devices to be too imprecise overall, with substantial outer-confidence bounds. On the plus side, Dr. Westenberg’s group said POC bilirubin testing was as much as 60 times faster than lab measurement, and used 40-60 times less blood. “Conventional laboratory-based bilirubin quantification usually requires up to 500 mcL, but sometimes even 1,500 mcL, while POC tests require up to 50 mcL, which means less stress for the baby,” Dr. Westenberg said in an interview. “Especially when infants are cared for at home, it usually takes a few hours between deciding to quantify bilirubin and obtaining the test result. Meanwhile, bilirubin levels may rise unnoticed.”
On the positive side, POC devices are useful where laboratories in low-resource areas may be remote, poorly equipped, and not always able to provide an accurate bilirubin level. “As a result, the diagnosis of jaundice relies mainly on visual inspection, which is known to be unreliable,” she said. POC devices, however, need near-perfect conditions for optimal use, and results can be affected by humidity, preanalytic conditions such as test strip saturation, and hematocrit.
Yet results from these devices have recently proven to have acceptable accuracy, resulting, for example, in the same clinical decisions as the reference standard in 90.7% of times according to a 2022 study in a hospital in Malawi.
Nevertheless, the authors concluded that the devices’ imprecision limits their widespread use in neonatal jaundice management, especially when accurate lab-based bilirubin quantification is available. Results from these POC tests should be interpreted with caution, Dr. Westenberg said. In terms of clinical decision-making, POC devices entail a risk of missing neonates with jaundice who need phototherapy or, in the case of overestimation, of starting phototherapy too early.
The study
The meta-analysis included nine cross-sectional and one prospective cohort study representing 3,122 neonates in Europe, Africa, and East and Southeast Asia. Two tests with 30-minute turnaround times were evaluated in neonates 0-28 days old. The Bilistick device was evaluated in eight studies and the BiliSpec (now called BiliDX) in just two studies. Three of the studies had a high risk of bias.
A total of 3,122 measurements paired with lab quantification showed a pooled mean difference in total bilirubin levels for the POC devices of –14 micromol/L, with pooled 95% confidence bounds (CBs) of –106 to 78 micromol/L. For the Bilistick, the pooled mean difference was –17 micromol/L (95% CBs, –114 to 80 micromol/L). Of the two devices, the Bilistick was more likely to have a failed quantification against the reference standard.
Context for POC devices
Commenting on the meta-analysis but not involved in it, Rebecca Richards-Kortum, PhD, a professor of biomedical engineering at Rice University in Houston, noted that both devices were developed specifically to address needs in low-resource settings. “I don’t think the meta-analysis acknowledges this rationale sufficiently,” she said. “It feels like this paper is comparing apples to oranges and then criticizing the apples for not being oranges,” said Dr. Richards-Kortum, who helped develop the BiliSpec test.
Similarly, Anne S. Lee, MD, MPH, an associate professor of pediatrics at Brigham and Women’s Hospital in Boston, and not a participant in the meta-analysis, also stressed that POC devices are designed for scenarios where lab-based results are not widely available. “In a broad sense, the devices fill an important gap, both in low- and middle-income countries, as well as in the U.S. when laboratory capacity is not readily available,” said Dr. Lee. She was involved the development of the Bili-ruler icterometer, which proved to be diagnostically accurate in Bangladeshi newborns.
“Access to this technology is a critical way to address health disparities even in the U.S.,” Dr. Lee continued. “We have heard of the need for this technology from the Indian health services and Alaskan health services, where decisions are made to airlift a child based on a visual inspection alone.”
More broadly, however, cautioned Dr. Westenberg, the total allowable error and the permissible limits of uncertainty in neonatal bilirubin quantification need to be defined – irrespective of the method used. “Accurate measurement of bilirubin is difficult as has been demonstrated in so-called external quality assessment (EQA) programs that exist for laboratory-based bilirubin methods,” she said. “EQA programs for POC bilirubin devices that include a reference method as a gold standard may contribute to adaptation of the device and improving POC test imprecision.”
This work was supported by the Netherlands Organization for Health Research and Development. The authors had no conflicts of interest to disclose. Dr. Richards-Kortum and Dr. Lee have both been involved in the development of POC devices for assessing neonatal bilirubin levels.
JAMA PEDIATRICS
In utero exposure to asthma medication not tied to risks of neurodevelopmental disorders
The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.
“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.
However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.
“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.
To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.
The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.
The findings were published in a research letter in JAMA Network Open.
In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).
After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).
Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.
The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.
The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.
“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.
The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.
The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.
“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.
However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.
“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.
To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.
The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.
The findings were published in a research letter in JAMA Network Open.
In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).
After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).
Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.
The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.
The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.
“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.
The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.
The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.
“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.
However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.
“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.
To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.
The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.
The findings were published in a research letter in JAMA Network Open.
In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).
After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).
Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.
The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.
The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.
“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.
The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Human and nonhuman milk products have similar effect on preemies’ gut microbiota
No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.
The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”
Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.
The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.
Neither, however, was powered to detect a clinically important difference in surgical NEC.
Milk and the microbiome
The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.
Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.
In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.
Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.
Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”
*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.
“They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”
The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.
Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”
He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.
So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”
Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”
More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”
The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.
*This story was updated on March 3, 2023.
No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.
The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”
Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.
The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.
Neither, however, was powered to detect a clinically important difference in surgical NEC.
Milk and the microbiome
The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.
Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.
In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.
Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.
Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”
*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.
“They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”
The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.
Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”
He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.
So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”
Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”
More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”
The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.
*This story was updated on March 3, 2023.
No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.
The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”
Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.
The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.
Neither, however, was powered to detect a clinically important difference in surgical NEC.
Milk and the microbiome
The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.
Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.
In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.
Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.
Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”
*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.
“They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”
The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.
Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”
He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.
So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”
Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”
More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”
The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.
*This story was updated on March 3, 2023.
FROM JAMA NETWORK OPEN
Myths about smoking, diet, alcohol, and cancer persist
FRANCE – Conducted every 5 years since 2005, the Cancer Survey documents the knowledge, perceptions, and way of life of the French people in relation to cancer. The researchers analyzed responses to telephone interviews of a representative sample of almost 5,000 individuals aged 15-85 years.
This study shows how thinking has changed over time and how difficult it is to alter preconceived notions.
Is cancer hereditary?
The report shows that 67.7% of respondents believe that cancer is a hereditary disease. Respondents were asked to explain their answer. “Data show that medical practices for cancer treatment substantiate this belief [that cancer is hereditary],” wrote the authors of the report.
“Indeed, health care professionals almost systematically ask questions about family history of breast cancer and, when a family member has been diagnosed with cancer, medical monitoring of other family members is often sought out, thus reinforcing the belief that cancer is hereditary,” they said.
Furthermore, there seems to be confusion regarding the role of genes in the development of cancer. A person can inherit cancer-predisposing genes, not cancer itself. The authors highlighted their concern that this confusion may “lead people to think that prevention measures are unnecessary because cancer is inherited.”
Misconceptions about smoking
About 41% of smokers think that the length of time one has been smoking is the biggest determining factor for developing cancer; 58.1% think the number of cigarettes smoked per day has a bigger impact.
Experts at InCA and SPF put the debate to rest, stating that prolonged exposure to carcinogenic substances is far more toxic. As for the danger threshold concerning the number of cigarettes smoked per day, respondents believed this to be 9.2 cigarettes per day, on average. They believed that the danger threshold for the number of years as an active smoker is 13.4, on average.
“The [survey] respondents clearly understand that smoking carries a risk, but many smokers think that light smoking or smoking for a short period of time doesn’t carry any risks.” Yet it is understood that even occasional tobacco consumption increases mortality.
This was not the only misconception regarding smoking and its relationship with cancer. About 34% of survey respondents agreed with the following statement: “Smoking doesn’t cause cancer unless you’re a heavy smoker and have smoked for a long time.” Furthermore, 43.3% agreed with the statement, “Pollution is more likely to cause cancer than smoking,” 54.6% think that “exercising cleans your lungs of tobacco,” and 61.6% think that “a smoker can prevent developing cancer caused by smoking if they know to quit on time.”
Overweight and obesity
Although diet and excess weight represent the third and fourth biggest avoidable cancer risk factors, after smoking and alcohol, only 30% of survey respondents knew of this link.
“Among the causes of cancer known and cited by respondents without prompting, excessive weight and obesity were mentioned only 100 times out of 12,558 responses,” highlighted the authors of the report. The explanation put forward by the authors is that discourse about diet has been more focused on diet as a protective health factor, especially in preventing cardiovascular diseases. “The link between cancer and diet is less prominent in the public space,” they noted.
Breastfeeding and cancer
About 63% of survey respondents, which for the first time included both women and men, believe that breastfeeding does not affect mothers’ risk of breast cancer, but this is a misconception. And almost 1 in 3 respondents said that breastfeeding provides health benefits for the mother.
Artificial UV rays
Exposure to UV rays, whether of natural or artificial origin, is a major risk factor for skin cancer. However, 1 in 5 people (20.9%) think that a session in a tanning bed is less harmful than sun exposure.
Daily stress
Regarding psychological factors linked to cancer, the authors noted that risk factors not supported by scientific evidence were, ironically, cited more often by respondents than proven risk factors. There is a real knowledge gap between scientific data and the beliefs of the French people. For example, “working at night” is largely not seen as a risk factor, but data show that it presents a clear risk. However, “not being able to express one’s feelings,” “having been weakened by traumatic experiences,” and “being exposed to the stress of modern life” are seen as risk factors of cancer, without any scientific evidence.
Cigarettes and e-cigarettes
About 53% of respondents agreed that “e-cigarettes are just as harmful or more harmful than traditional cigarettes.” Nicotine and the flavors in e-cigarettes are largely perceived as “very” or “extremely” harmful to the health of a person. However, the authors note that “no published study on nicotine substitutes has shown harmful effects on the health of a person, let alone determined it a risk factor for cancer. The nicotine doses in e-cigarettes are similar to traditional nicotine substitutes, and no cytotoxic effect of nicotine in its inhaled form has been found.” There seems to be confusion between dependence and risk of cancer.
Alcohol consumption
Eight of 10 respondents believe that “some people can drink a lot of alcohol all their life without ever getting cancer,” which goes against the scientific literature. The authors of the report state that the negative effects of alcohol on health seem poorly understood. Although alcohol is the second biggest cause of cancer, only a third of survey respondents cited it without having been prompted as one of the main causes of cancer. And 23.5% even think that “in terms of decreasing your risk of cancer, it’s better to drink a little wine than to drink no wine at all.”
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.
FRANCE – Conducted every 5 years since 2005, the Cancer Survey documents the knowledge, perceptions, and way of life of the French people in relation to cancer. The researchers analyzed responses to telephone interviews of a representative sample of almost 5,000 individuals aged 15-85 years.
This study shows how thinking has changed over time and how difficult it is to alter preconceived notions.
Is cancer hereditary?
The report shows that 67.7% of respondents believe that cancer is a hereditary disease. Respondents were asked to explain their answer. “Data show that medical practices for cancer treatment substantiate this belief [that cancer is hereditary],” wrote the authors of the report.
“Indeed, health care professionals almost systematically ask questions about family history of breast cancer and, when a family member has been diagnosed with cancer, medical monitoring of other family members is often sought out, thus reinforcing the belief that cancer is hereditary,” they said.
Furthermore, there seems to be confusion regarding the role of genes in the development of cancer. A person can inherit cancer-predisposing genes, not cancer itself. The authors highlighted their concern that this confusion may “lead people to think that prevention measures are unnecessary because cancer is inherited.”
Misconceptions about smoking
About 41% of smokers think that the length of time one has been smoking is the biggest determining factor for developing cancer; 58.1% think the number of cigarettes smoked per day has a bigger impact.
Experts at InCA and SPF put the debate to rest, stating that prolonged exposure to carcinogenic substances is far more toxic. As for the danger threshold concerning the number of cigarettes smoked per day, respondents believed this to be 9.2 cigarettes per day, on average. They believed that the danger threshold for the number of years as an active smoker is 13.4, on average.
“The [survey] respondents clearly understand that smoking carries a risk, but many smokers think that light smoking or smoking for a short period of time doesn’t carry any risks.” Yet it is understood that even occasional tobacco consumption increases mortality.
This was not the only misconception regarding smoking and its relationship with cancer. About 34% of survey respondents agreed with the following statement: “Smoking doesn’t cause cancer unless you’re a heavy smoker and have smoked for a long time.” Furthermore, 43.3% agreed with the statement, “Pollution is more likely to cause cancer than smoking,” 54.6% think that “exercising cleans your lungs of tobacco,” and 61.6% think that “a smoker can prevent developing cancer caused by smoking if they know to quit on time.”
Overweight and obesity
Although diet and excess weight represent the third and fourth biggest avoidable cancer risk factors, after smoking and alcohol, only 30% of survey respondents knew of this link.
“Among the causes of cancer known and cited by respondents without prompting, excessive weight and obesity were mentioned only 100 times out of 12,558 responses,” highlighted the authors of the report. The explanation put forward by the authors is that discourse about diet has been more focused on diet as a protective health factor, especially in preventing cardiovascular diseases. “The link between cancer and diet is less prominent in the public space,” they noted.
Breastfeeding and cancer
About 63% of survey respondents, which for the first time included both women and men, believe that breastfeeding does not affect mothers’ risk of breast cancer, but this is a misconception. And almost 1 in 3 respondents said that breastfeeding provides health benefits for the mother.
Artificial UV rays
Exposure to UV rays, whether of natural or artificial origin, is a major risk factor for skin cancer. However, 1 in 5 people (20.9%) think that a session in a tanning bed is less harmful than sun exposure.
Daily stress
Regarding psychological factors linked to cancer, the authors noted that risk factors not supported by scientific evidence were, ironically, cited more often by respondents than proven risk factors. There is a real knowledge gap between scientific data and the beliefs of the French people. For example, “working at night” is largely not seen as a risk factor, but data show that it presents a clear risk. However, “not being able to express one’s feelings,” “having been weakened by traumatic experiences,” and “being exposed to the stress of modern life” are seen as risk factors of cancer, without any scientific evidence.
Cigarettes and e-cigarettes
About 53% of respondents agreed that “e-cigarettes are just as harmful or more harmful than traditional cigarettes.” Nicotine and the flavors in e-cigarettes are largely perceived as “very” or “extremely” harmful to the health of a person. However, the authors note that “no published study on nicotine substitutes has shown harmful effects on the health of a person, let alone determined it a risk factor for cancer. The nicotine doses in e-cigarettes are similar to traditional nicotine substitutes, and no cytotoxic effect of nicotine in its inhaled form has been found.” There seems to be confusion between dependence and risk of cancer.
Alcohol consumption
Eight of 10 respondents believe that “some people can drink a lot of alcohol all their life without ever getting cancer,” which goes against the scientific literature. The authors of the report state that the negative effects of alcohol on health seem poorly understood. Although alcohol is the second biggest cause of cancer, only a third of survey respondents cited it without having been prompted as one of the main causes of cancer. And 23.5% even think that “in terms of decreasing your risk of cancer, it’s better to drink a little wine than to drink no wine at all.”
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.
FRANCE – Conducted every 5 years since 2005, the Cancer Survey documents the knowledge, perceptions, and way of life of the French people in relation to cancer. The researchers analyzed responses to telephone interviews of a representative sample of almost 5,000 individuals aged 15-85 years.
This study shows how thinking has changed over time and how difficult it is to alter preconceived notions.
Is cancer hereditary?
The report shows that 67.7% of respondents believe that cancer is a hereditary disease. Respondents were asked to explain their answer. “Data show that medical practices for cancer treatment substantiate this belief [that cancer is hereditary],” wrote the authors of the report.
“Indeed, health care professionals almost systematically ask questions about family history of breast cancer and, when a family member has been diagnosed with cancer, medical monitoring of other family members is often sought out, thus reinforcing the belief that cancer is hereditary,” they said.
Furthermore, there seems to be confusion regarding the role of genes in the development of cancer. A person can inherit cancer-predisposing genes, not cancer itself. The authors highlighted their concern that this confusion may “lead people to think that prevention measures are unnecessary because cancer is inherited.”
Misconceptions about smoking
About 41% of smokers think that the length of time one has been smoking is the biggest determining factor for developing cancer; 58.1% think the number of cigarettes smoked per day has a bigger impact.
Experts at InCA and SPF put the debate to rest, stating that prolonged exposure to carcinogenic substances is far more toxic. As for the danger threshold concerning the number of cigarettes smoked per day, respondents believed this to be 9.2 cigarettes per day, on average. They believed that the danger threshold for the number of years as an active smoker is 13.4, on average.
“The [survey] respondents clearly understand that smoking carries a risk, but many smokers think that light smoking or smoking for a short period of time doesn’t carry any risks.” Yet it is understood that even occasional tobacco consumption increases mortality.
This was not the only misconception regarding smoking and its relationship with cancer. About 34% of survey respondents agreed with the following statement: “Smoking doesn’t cause cancer unless you’re a heavy smoker and have smoked for a long time.” Furthermore, 43.3% agreed with the statement, “Pollution is more likely to cause cancer than smoking,” 54.6% think that “exercising cleans your lungs of tobacco,” and 61.6% think that “a smoker can prevent developing cancer caused by smoking if they know to quit on time.”
Overweight and obesity
Although diet and excess weight represent the third and fourth biggest avoidable cancer risk factors, after smoking and alcohol, only 30% of survey respondents knew of this link.
“Among the causes of cancer known and cited by respondents without prompting, excessive weight and obesity were mentioned only 100 times out of 12,558 responses,” highlighted the authors of the report. The explanation put forward by the authors is that discourse about diet has been more focused on diet as a protective health factor, especially in preventing cardiovascular diseases. “The link between cancer and diet is less prominent in the public space,” they noted.
Breastfeeding and cancer
About 63% of survey respondents, which for the first time included both women and men, believe that breastfeeding does not affect mothers’ risk of breast cancer, but this is a misconception. And almost 1 in 3 respondents said that breastfeeding provides health benefits for the mother.
Artificial UV rays
Exposure to UV rays, whether of natural or artificial origin, is a major risk factor for skin cancer. However, 1 in 5 people (20.9%) think that a session in a tanning bed is less harmful than sun exposure.
Daily stress
Regarding psychological factors linked to cancer, the authors noted that risk factors not supported by scientific evidence were, ironically, cited more often by respondents than proven risk factors. There is a real knowledge gap between scientific data and the beliefs of the French people. For example, “working at night” is largely not seen as a risk factor, but data show that it presents a clear risk. However, “not being able to express one’s feelings,” “having been weakened by traumatic experiences,” and “being exposed to the stress of modern life” are seen as risk factors of cancer, without any scientific evidence.
Cigarettes and e-cigarettes
About 53% of respondents agreed that “e-cigarettes are just as harmful or more harmful than traditional cigarettes.” Nicotine and the flavors in e-cigarettes are largely perceived as “very” or “extremely” harmful to the health of a person. However, the authors note that “no published study on nicotine substitutes has shown harmful effects on the health of a person, let alone determined it a risk factor for cancer. The nicotine doses in e-cigarettes are similar to traditional nicotine substitutes, and no cytotoxic effect of nicotine in its inhaled form has been found.” There seems to be confusion between dependence and risk of cancer.
Alcohol consumption
Eight of 10 respondents believe that “some people can drink a lot of alcohol all their life without ever getting cancer,” which goes against the scientific literature. The authors of the report state that the negative effects of alcohol on health seem poorly understood. Although alcohol is the second biggest cause of cancer, only a third of survey respondents cited it without having been prompted as one of the main causes of cancer. And 23.5% even think that “in terms of decreasing your risk of cancer, it’s better to drink a little wine than to drink no wine at all.”
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.