Neonatal Medicine

You’re rounding in the nursery and informed of the following about one of your new patients: He’s a 38-week-old infant delivered to a mother diagnosed with syphilis at 12 weeks’ gestation at her initial prenatal visit. Her rapid plasma reagin (RPR) was 1:64 and the fluorescent treponemal antibody–absorption (FTA-ABS) test was positive. By report she was appropriately treated. Maternal RPRs obtained at 18 and 28 weeks’ gestation were 1:16 and 1:4, respectively. Maternal RPR at delivery and the infant’s RPR obtained shortly after birth were both 1:4. The mother wants to know if her baby is infected.

One result of syphilis during pregnancy is intrauterine infection and resultant congenital disease in the infant. Before you answer this mother, let’s discuss syphilis.

Congenital syphilis is a significant public health problem. In 2021, there were a total of 2,677 cases reported for a rate of 74.1 per 100,000 live births. Between 2020 and 2021, the number of cases of congenital syphilis increased 24.1% (2,158-2,677 cases), concurrent with a 45.8% increase (10.7-15.6 per 100,000) in the rate of primary and secondary syphilis in women aged 15-44 years. Between 2012 and 2021, the number of cases of congenital syphilis increased 701.5% (334-2,677 cases) and the increase in rates of primary and secondary syphilis in women aged 15-44 was 642.9% over the same period.

Why are the rates of congenital syphilis increasing? Most cases result from a lack of prenatal care and thus no testing for syphilis. The next most common cause is inadequate maternal treatment.

Congenital syphilis usually is acquired through transplacental transmission of spirochetes in the maternal bloodstream. Occasionally, it occurs at delivery via direct contact with maternal lesions. It is not transmitted in breast milk. Transmission of syphilis:

• Can occur any time during pregnancy.
• Is more likely to occur in women with untreated primary or secondary disease (60%-100%).
• Is approximately 40% in those with early latent syphilis and less than 8% in mothers with late latent syphilis.
• Is higher in women coinfected with HIV since they more frequently receive no prenatal care and their disease is inadequately treated.

Coinfection with syphilis may also increase the rate of mother-to-child transmission of HIV.

Untreated early syphilis during pregnancy results in spontaneous abortion, stillbirth, or perinatal death in up to 40% of cases. Infected newborns with early congenital syphilis can be asymptomatic or have evidence of hepatosplenomegaly, generalized lymphadenopathy, nasal discharge that is occasionally bloody, rash, and skeletal abnormalities (osteochondritis and periostitis). Other manifestations include edema, hemolytic anemia, jaundice, pneumonia, pseudoparalysis, and thrombocytopenia. Asymptomatic infants may have abnormal cerebrospinal fluid findings including elevated CSF white cell count, elevated protein, and a reactive venereal disease research laboratory test.

Late congenital syphilis, defined as the onset of symptoms after 2 years of age is secondary to scarring or persistent inflammation and gumma formation in a variety of tissues. It occurs in up to 40% of cases of untreated maternal disease. Most cases can be prevented by maternal treatment and treatment of the infant within the first 3 months of life. Common clinical manifestations include interstitial keratitis, sensorineural hearing loss, frontal bossing, saddle nose, Hutchinson teeth, mulberry molars, perforation of the hard palate, anterior bowing of the tibia (saber shins), and other skeletal abnormalities.

Diagnostic tests. Maternal diagnosis is dependent upon knowing the results of both a nontreponemal (RPR, VDRL) and a confirmatory treponemal test (TP-PA, TP-EIA, TP-CIA, FTA-ABS,) before or at delivery. TP-PA is the preferred test. When maternal disease is confirmed, the newborn should have the same quantitative nontreponemal test as the mother. A confirmatory treponemal test is not required

Evaluation and treatment. It’s imperative that children born to mothers with a reactive test, regardless of their treatment status, have a thorough exam performed before hospital discharge. The provider must determine what additional interventions should be performed.

The American Academy of Pediatrics and the Centers for Disease Control and Prevention (www.cdc.gov/std/treatment-guidelines/congenital-syphilis.htm) have developed standard algorithms for the diagnostic approach and treatment of infants born to mothers with reactive serologic tests for syphilis. It is available in the Red Book for AAP members (https://publications.aap.org/redbook). Recommendations based on various scenarios for neonates up to 1 month of age include proven or highly probable congenital syphilis, possible congenital syphilis, congenital syphilis less likely, and congenital syphilis unlikely. It is beyond the scope of this article to list the criteria and evaluation for each scenario. The reader is referred to the algorithm.

If syphilis is suspected in infants or children older than 1 month, the challenge is to determine if it is untreated congenital syphilis or acquired syphilis. Maternal syphilis status should be determined. Evaluation for congenital syphilis in this age group includes CSF analysis for VDRL, cell count and protein, CBC with differential and platelets, hepatic panel, abdominal ultrasound, long-bone radiographs, chest radiograph, neuroimaging, auditory brain stem response, and HIV testing.

Let’s go back to your patient. The mother was diagnosed with syphilis during pregnancy. You confirm that she was treated with benzathine penicillin G, and the course was completed at least 4 weeks before delivery. Treatment with any other drug during pregnancy is not appropriate. The RPR has declined, and the infant’s titer is equal to or less than four times the maternal titer. The exam is significant for generalized adenopathy and slightly bloody nasal discharge. This infant has two findings consistent with congenital syphilis regardless of RPR titer or treatment status. This places him in the proven or highly probable congenital syphilis group. Management includes CSF analysis (VDRL, cell count, and protein), CBC with differential and platelet count, and treatment with penicillin G for 10 days. Additional tests as clinically indicated include: long-bone radiograph, chest radiography, aspartate aminotranferase and alanine aminotransferase levels, neuroimaging, ophthalmologic exam, and auditory brain stem response. Despite maternal treatment, this newborn has congenital syphilis. The same nontreponemal test should be obtained every 2-3 months until it is nonreactive. It should be nonreactive by 6 months. If the infection persists to 6-12 months post treatment, reevaluation including CSF analysis and retreatment may be indicated.

Congenital syphilis can be prevented by maternal screening, diagnosis, and treatment. When that fails it is up to us to diagnosis and adequately treat our patients.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

You’re rounding in the nursery and informed of the following about one of your new patients: He’s a 38-week-old infant delivered to a mother diagnosed with syphilis at 12 weeks’ gestation at her initial prenatal visit. Her rapid plasma reagin (RPR) was 1:64 and the fluorescent treponemal antibody–absorption (FTA-ABS) test was positive. By report she was appropriately treated. Maternal RPRs obtained at 18 and 28 weeks’ gestation were 1:16 and 1:4, respectively. Maternal RPR at delivery and the infant’s RPR obtained shortly after birth were both 1:4. The mother wants to know if her baby is infected.

One result of syphilis during pregnancy is intrauterine infection and resultant congenital disease in the infant. Before you answer this mother, let’s discuss syphilis.

Congenital syphilis is a significant public health problem. In 2021, there were a total of 2,677 cases reported for a rate of 74.1 per 100,000 live births. Between 2020 and 2021, the number of cases of congenital syphilis increased 24.1% (2,158-2,677 cases), concurrent with a 45.8% increase (10.7-15.6 per 100,000) in the rate of primary and secondary syphilis in women aged 15-44 years. Between 2012 and 2021, the number of cases of congenital syphilis increased 701.5% (334-2,677 cases) and the increase in rates of primary and secondary syphilis in women aged 15-44 was 642.9% over the same period.

Why are the rates of congenital syphilis increasing? Most cases result from a lack of prenatal care and thus no testing for syphilis. The next most common cause is inadequate maternal treatment.

Congenital syphilis usually is acquired through transplacental transmission of spirochetes in the maternal bloodstream. Occasionally, it occurs at delivery via direct contact with maternal lesions. It is not transmitted in breast milk. Transmission of syphilis:

• Can occur any time during pregnancy.
• Is more likely to occur in women with untreated primary or secondary disease (60%-100%).
• Is approximately 40% in those with early latent syphilis and less than 8% in mothers with late latent syphilis.
• Is higher in women coinfected with HIV since they more frequently receive no prenatal care and their disease is inadequately treated.

Coinfection with syphilis may also increase the rate of mother-to-child transmission of HIV.

Untreated early syphilis during pregnancy results in spontaneous abortion, stillbirth, or perinatal death in up to 40% of cases. Infected newborns with early congenital syphilis can be asymptomatic or have evidence of hepatosplenomegaly, generalized lymphadenopathy, nasal discharge that is occasionally bloody, rash, and skeletal abnormalities (osteochondritis and periostitis). Other manifestations include edema, hemolytic anemia, jaundice, pneumonia, pseudoparalysis, and thrombocytopenia. Asymptomatic infants may have abnormal cerebrospinal fluid findings including elevated CSF white cell count, elevated protein, and a reactive venereal disease research laboratory test.

Late congenital syphilis, defined as the onset of symptoms after 2 years of age is secondary to scarring or persistent inflammation and gumma formation in a variety of tissues. It occurs in up to 40% of cases of untreated maternal disease. Most cases can be prevented by maternal treatment and treatment of the infant within the first 3 months of life. Common clinical manifestations include interstitial keratitis, sensorineural hearing loss, frontal bossing, saddle nose, Hutchinson teeth, mulberry molars, perforation of the hard palate, anterior bowing of the tibia (saber shins), and other skeletal abnormalities.

Diagnostic tests. Maternal diagnosis is dependent upon knowing the results of both a nontreponemal (RPR, VDRL) and a confirmatory treponemal test (TP-PA, TP-EIA, TP-CIA, FTA-ABS,) before or at delivery. TP-PA is the preferred test. When maternal disease is confirmed, the newborn should have the same quantitative nontreponemal test as the mother. A confirmatory treponemal test is not required

Evaluation and treatment. It’s imperative that children born to mothers with a reactive test, regardless of their treatment status, have a thorough exam performed before hospital discharge. The provider must determine what additional interventions should be performed.

The American Academy of Pediatrics and the Centers for Disease Control and Prevention (www.cdc.gov/std/treatment-guidelines/congenital-syphilis.htm) have developed standard algorithms for the diagnostic approach and treatment of infants born to mothers with reactive serologic tests for syphilis. It is available in the Red Book for AAP members (https://publications.aap.org/redbook). Recommendations based on various scenarios for neonates up to 1 month of age include proven or highly probable congenital syphilis, possible congenital syphilis, congenital syphilis less likely, and congenital syphilis unlikely. It is beyond the scope of this article to list the criteria and evaluation for each scenario. The reader is referred to the algorithm.

If syphilis is suspected in infants or children older than 1 month, the challenge is to determine if it is untreated congenital syphilis or acquired syphilis. Maternal syphilis status should be determined. Evaluation for congenital syphilis in this age group includes CSF analysis for VDRL, cell count and protein, CBC with differential and platelets, hepatic panel, abdominal ultrasound, long-bone radiographs, chest radiograph, neuroimaging, auditory brain stem response, and HIV testing.

Let’s go back to your patient. The mother was diagnosed with syphilis during pregnancy. You confirm that she was treated with benzathine penicillin G, and the course was completed at least 4 weeks before delivery. Treatment with any other drug during pregnancy is not appropriate. The RPR has declined, and the infant’s titer is equal to or less than four times the maternal titer. The exam is significant for generalized adenopathy and slightly bloody nasal discharge. This infant has two findings consistent with congenital syphilis regardless of RPR titer or treatment status. This places him in the proven or highly probable congenital syphilis group. Management includes CSF analysis (VDRL, cell count, and protein), CBC with differential and platelet count, and treatment with penicillin G for 10 days. Additional tests as clinically indicated include: long-bone radiograph, chest radiography, aspartate aminotranferase and alanine aminotransferase levels, neuroimaging, ophthalmologic exam, and auditory brain stem response. Despite maternal treatment, this newborn has congenital syphilis. The same nontreponemal test should be obtained every 2-3 months until it is nonreactive. It should be nonreactive by 6 months. If the infection persists to 6-12 months post treatment, reevaluation including CSF analysis and retreatment may be indicated.

Congenital syphilis can be prevented by maternal screening, diagnosis, and treatment. When that fails it is up to us to diagnosis and adequately treat our patients.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

You’re rounding in the nursery and informed of the following about one of your new patients: He’s a 38-week-old infant delivered to a mother diagnosed with syphilis at 12 weeks’ gestation at her initial prenatal visit. Her rapid plasma reagin (RPR) was 1:64 and the fluorescent treponemal antibody–absorption (FTA-ABS) test was positive. By report she was appropriately treated. Maternal RPRs obtained at 18 and 28 weeks’ gestation were 1:16 and 1:4, respectively. Maternal RPR at delivery and the infant’s RPR obtained shortly after birth were both 1:4. The mother wants to know if her baby is infected.

One result of syphilis during pregnancy is intrauterine infection and resultant congenital disease in the infant. Before you answer this mother, let’s discuss syphilis.

Congenital syphilis is a significant public health problem. In 2021, there were a total of 2,677 cases reported for a rate of 74.1 per 100,000 live births. Between 2020 and 2021, the number of cases of congenital syphilis increased 24.1% (2,158-2,677 cases), concurrent with a 45.8% increase (10.7-15.6 per 100,000) in the rate of primary and secondary syphilis in women aged 15-44 years. Between 2012 and 2021, the number of cases of congenital syphilis increased 701.5% (334-2,677 cases) and the increase in rates of primary and secondary syphilis in women aged 15-44 was 642.9% over the same period.

Why are the rates of congenital syphilis increasing? Most cases result from a lack of prenatal care and thus no testing for syphilis. The next most common cause is inadequate maternal treatment.

Congenital syphilis usually is acquired through transplacental transmission of spirochetes in the maternal bloodstream. Occasionally, it occurs at delivery via direct contact with maternal lesions. It is not transmitted in breast milk. Transmission of syphilis:

• Can occur any time during pregnancy.
• Is more likely to occur in women with untreated primary or secondary disease (60%-100%).
• Is approximately 40% in those with early latent syphilis and less than 8% in mothers with late latent syphilis.
• Is higher in women coinfected with HIV since they more frequently receive no prenatal care and their disease is inadequately treated.

Coinfection with syphilis may also increase the rate of mother-to-child transmission of HIV.

Untreated early syphilis during pregnancy results in spontaneous abortion, stillbirth, or perinatal death in up to 40% of cases. Infected newborns with early congenital syphilis can be asymptomatic or have evidence of hepatosplenomegaly, generalized lymphadenopathy, nasal discharge that is occasionally bloody, rash, and skeletal abnormalities (osteochondritis and periostitis). Other manifestations include edema, hemolytic anemia, jaundice, pneumonia, pseudoparalysis, and thrombocytopenia. Asymptomatic infants may have abnormal cerebrospinal fluid findings including elevated CSF white cell count, elevated protein, and a reactive venereal disease research laboratory test.

Late congenital syphilis, defined as the onset of symptoms after 2 years of age is secondary to scarring or persistent inflammation and gumma formation in a variety of tissues. It occurs in up to 40% of cases of untreated maternal disease. Most cases can be prevented by maternal treatment and treatment of the infant within the first 3 months of life. Common clinical manifestations include interstitial keratitis, sensorineural hearing loss, frontal bossing, saddle nose, Hutchinson teeth, mulberry molars, perforation of the hard palate, anterior bowing of the tibia (saber shins), and other skeletal abnormalities.

Diagnostic tests. Maternal diagnosis is dependent upon knowing the results of both a nontreponemal (RPR, VDRL) and a confirmatory treponemal test (TP-PA, TP-EIA, TP-CIA, FTA-ABS,) before or at delivery. TP-PA is the preferred test. When maternal disease is confirmed, the newborn should have the same quantitative nontreponemal test as the mother. A confirmatory treponemal test is not required

Evaluation and treatment. It’s imperative that children born to mothers with a reactive test, regardless of their treatment status, have a thorough exam performed before hospital discharge. The provider must determine what additional interventions should be performed.

The American Academy of Pediatrics and the Centers for Disease Control and Prevention (www.cdc.gov/std/treatment-guidelines/congenital-syphilis.htm) have developed standard algorithms for the diagnostic approach and treatment of infants born to mothers with reactive serologic tests for syphilis. It is available in the Red Book for AAP members (https://publications.aap.org/redbook). Recommendations based on various scenarios for neonates up to 1 month of age include proven or highly probable congenital syphilis, possible congenital syphilis, congenital syphilis less likely, and congenital syphilis unlikely. It is beyond the scope of this article to list the criteria and evaluation for each scenario. The reader is referred to the algorithm.

If syphilis is suspected in infants or children older than 1 month, the challenge is to determine if it is untreated congenital syphilis or acquired syphilis. Maternal syphilis status should be determined. Evaluation for congenital syphilis in this age group includes CSF analysis for VDRL, cell count and protein, CBC with differential and platelets, hepatic panel, abdominal ultrasound, long-bone radiographs, chest radiograph, neuroimaging, auditory brain stem response, and HIV testing.

Let’s go back to your patient. The mother was diagnosed with syphilis during pregnancy. You confirm that she was treated with benzathine penicillin G, and the course was completed at least 4 weeks before delivery. Treatment with any other drug during pregnancy is not appropriate. The RPR has declined, and the infant’s titer is equal to or less than four times the maternal titer. The exam is significant for generalized adenopathy and slightly bloody nasal discharge. This infant has two findings consistent with congenital syphilis regardless of RPR titer or treatment status. This places him in the proven or highly probable congenital syphilis group. Management includes CSF analysis (VDRL, cell count, and protein), CBC with differential and platelet count, and treatment with penicillin G for 10 days. Additional tests as clinically indicated include: long-bone radiograph, chest radiography, aspartate aminotranferase and alanine aminotransferase levels, neuroimaging, ophthalmologic exam, and auditory brain stem response. Despite maternal treatment, this newborn has congenital syphilis. The same nontreponemal test should be obtained every 2-3 months until it is nonreactive. It should be nonreactive by 6 months. If the infection persists to 6-12 months post treatment, reevaluation including CSF analysis and retreatment may be indicated.

Congenital syphilis can be prevented by maternal screening, diagnosis, and treatment. When that fails it is up to us to diagnosis and adequately treat our patients.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

Congenital cytomegalovirus cases declined significantly during the COVID-19 pandemic, compared with a period before the pandemic, based on data from nearly 20,000 newborns.

A study originated to explore racial and ethnic differences in congenital cytomegalovirus (cCMV) began in 2016, but was halted in April 2020 because of the COVID-19 pandemic, wrote Mark R. Schleiss, MD, of the University of Minnesota, Minneapolis, and colleagues. The study resumed for a period from August 2020 to December 2021, and the researchers compared data on cCMV before and during the pandemic. The prepandemic period included data from April 2016 to March 2020.

“We have been screening for congenital CMV infection in Minnesota for 6 years as a part of a multicenter collaborative study that I lead as the primary investigator,” Dr. Schleiss said in an interview. “Our efforts have contributed to the decision, vetted through the Minnesota Legislature and signed into law in 2021 (the “Vivian Act”), to begin universal screening for all newborns in Minnesota in 2023. In the context of this ongoing screening/surveillance study, it was important and scientifically very interesting to examine the impact of the COVID-19 pandemic on the risk of congenital CMV infection,” he explained.

The findings were published in a research letter in JAMA Network Open. A total of 15,697 newborns were screened before the pandemic and 4,222 were screened during the pandemic period at six hospitals. The majority of the mothers participating during the prepandemic and pandemic periods were non-Hispanic White (71% and 60%, respectively).

Overall, the percentage screened prevalence for cCMV was 79% in the prepandemic period and 21% during the pandemic, with rates of 4.5 per 1,000 and 1.4 per 1,000, respectively.

Although the highest percentage of cCMV cases occurred in newborns of mothers aged 25 years and older (86%), the prevalence was highest among newborns of mothers aged 24 years and younger (6.0 per 1,000). The prevalence of cCMV overall was higher in infants of non-Hispanic Black mothers vs. non-Hispanic White mothers, but not significantly different (5.1 per 1,000 vs. 4.6 per 1,000) and among second newborns vs. first newborns (6.0 vs. 3.2 per 1,000, respectively).

Factors related to COVID-19, including reduced day care attendance, behavioral changes, and mitigation measures at childcare facilities such as smaller classes and increased hand hygiene and disinfection may have contributed to this decrease in cCMV in the pandemic period, the researchers wrote in their discussion.

The comparable prevalence in newborns of non-Hispanic Black and White mothers contrasts with previous studies showing a higher prevalence in children of non-Hispanic Black mothers, the researchers noted in their discussion.

The study was limited by several factors, including the variation in time points for enrollment at different sites and the exclusion of families in the newborn nursery with positive COVID-19 results during the pandemic, they wrote. More research is needed on the potential effects of behavioral interventions to reduce CMV risk during pregnancy, as well as future CMV vaccination for childbearing-aged women and young children, they concluded.

However, the researchers were surprised by the impact of COVID-19 on the prevalence of cCMV, Dr. Schleiss said in an interview. “We have had the knowledge for many years that CMV infections in young women are commonly acquired through interactions with their toddlers. These interactions – sharing food, wiping drool and nasal discharge from the toddler’s nose, changing diapers, kissing the child on the mouth – can transmit CMV,” he said. In addition, toddlers may acquire CMV from group day care; the child then sheds CMV and transmits the virus to their pregnant mother, who then transmits the virus across the placenta, leading to cCMV infection in the newborn, Dr. Schleiss explained.

Although the researchers expected a decrease in CMV in the wake of closures of group day care, increased home schooling, decreased interactions among children, hygienic precautions, and social isolation, the decrease exceeded their expectations, said Dr. Schleiss. “Our previous work showed that in the 5-year period leading up to the pandemic, about one baby in every 200 births was born with CMV. Between August 2020 and December 2021, the number decreased to one baby in every 1,000 births,” a difference he and his team found striking.

The message from the study is that CMV can be prevented, said Dr. Schleiss. “Hygienic precautions during pregnancy had a big impact. Since congenital CMV infection is the most common congenital infection in the United States, and probably globally, that causes disabilities in children, the implications are highly significant,” he said. “The hygienic precautions we all have engaged in during the pandemic, such as masking, handwashing, and infection prevention behaviors, were almost certainly responsible for the reduction in CMV transmission, which in turn protected mothers and newborns from the potentially devastating effects of the CMV virus,” he noted.

Looking ahead, “Vaccines are moving forward in clinical trials that aim to confer immunity on young women of childbearing age to protect future pregnancies against transmission of CMV to the newborn infant; it would be very important to examine in future studies whether hygienic precautions would have the same impact as a potential vaccine,” Dr. Schleiss said. More research is needed to examine the effect of education of women about CMV transmission, he added. “We think it is very important to share this knowledge from our study with the pediatric community, since pediatricians can be important in counseling women about future pregnancies and the risks of CMV acquisition and transmission,” he noted.

Implications for other viruses

Although CMV poses minimal risk for healthy populations, irreversible complications for infants born with congenital CMV, especially hearing loss, are very concerning, said Catherine Haut, DNP, CPNP-AC/PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview.

“The study of viral transmission during a time of isolation, masking, and other mitigation procedures for COVID-19 assists in awareness that other viruses may also be limited with the use of these measures,” she said.

Dr. Haut was not surprised by the findings, given that CMV is transmitted primarily through direct contact with body fluids and that more than 50% of American adults have been infected by age 40, according to the Centers for Disease Control and Prevention, she said.

The take-home message for pediatricians, Dr. Haut said, is measures to prevent transmission of viral infection can yield significant positive health outcomes for the pediatric population; however, the effect of isolation, which has been associated with a higher rate of mental health problems, should not be ignored.

“Despite appropriate statistical analyses and presentation of findings in this study, the population sampled during the pandemic was less than 30% of the pre-COVID sampling, representing a study limitation,” and conducting research in a single state limits generalizability, Dr. Haut noted. “I agree with the authors that additional study is necessary to better understand prevention measures and apply these methods to reduce CMV transmission. Pursuit of CMV immunization opportunities is also needed,” she said.

The study was supported by the Centers for Disease Control and Prevention, the National Vaccine Program Office, the Minnesota Department of Health Newborn Screening Program, and the University of South Carolina Disability Research and Dissemination Center. Lead author Dr. Schleiss disclosed grants from the CDC, the National Institutes of Health, and the DRDC during the conduct of the study; he also disclosed receiving personal fees from Moderna, Sanofi, GlaxoSmithKline, and Merck unrelated to the study. Dr. Haut had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

Congenital cytomegalovirus cases declined significantly during the COVID-19 pandemic, compared with a period before the pandemic, based on data from nearly 20,000 newborns.

A study originated to explore racial and ethnic differences in congenital cytomegalovirus (cCMV) began in 2016, but was halted in April 2020 because of the COVID-19 pandemic, wrote Mark R. Schleiss, MD, of the University of Minnesota, Minneapolis, and colleagues. The study resumed for a period from August 2020 to December 2021, and the researchers compared data on cCMV before and during the pandemic. The prepandemic period included data from April 2016 to March 2020.

“We have been screening for congenital CMV infection in Minnesota for 6 years as a part of a multicenter collaborative study that I lead as the primary investigator,” Dr. Schleiss said in an interview. “Our efforts have contributed to the decision, vetted through the Minnesota Legislature and signed into law in 2021 (the “Vivian Act”), to begin universal screening for all newborns in Minnesota in 2023. In the context of this ongoing screening/surveillance study, it was important and scientifically very interesting to examine the impact of the COVID-19 pandemic on the risk of congenital CMV infection,” he explained.

The findings were published in a research letter in JAMA Network Open. A total of 15,697 newborns were screened before the pandemic and 4,222 were screened during the pandemic period at six hospitals. The majority of the mothers participating during the prepandemic and pandemic periods were non-Hispanic White (71% and 60%, respectively).

Overall, the percentage screened prevalence for cCMV was 79% in the prepandemic period and 21% during the pandemic, with rates of 4.5 per 1,000 and 1.4 per 1,000, respectively.

Although the highest percentage of cCMV cases occurred in newborns of mothers aged 25 years and older (86%), the prevalence was highest among newborns of mothers aged 24 years and younger (6.0 per 1,000). The prevalence of cCMV overall was higher in infants of non-Hispanic Black mothers vs. non-Hispanic White mothers, but not significantly different (5.1 per 1,000 vs. 4.6 per 1,000) and among second newborns vs. first newborns (6.0 vs. 3.2 per 1,000, respectively).

Factors related to COVID-19, including reduced day care attendance, behavioral changes, and mitigation measures at childcare facilities such as smaller classes and increased hand hygiene and disinfection may have contributed to this decrease in cCMV in the pandemic period, the researchers wrote in their discussion.

The comparable prevalence in newborns of non-Hispanic Black and White mothers contrasts with previous studies showing a higher prevalence in children of non-Hispanic Black mothers, the researchers noted in their discussion.

The study was limited by several factors, including the variation in time points for enrollment at different sites and the exclusion of families in the newborn nursery with positive COVID-19 results during the pandemic, they wrote. More research is needed on the potential effects of behavioral interventions to reduce CMV risk during pregnancy, as well as future CMV vaccination for childbearing-aged women and young children, they concluded.

However, the researchers were surprised by the impact of COVID-19 on the prevalence of cCMV, Dr. Schleiss said in an interview. “We have had the knowledge for many years that CMV infections in young women are commonly acquired through interactions with their toddlers. These interactions – sharing food, wiping drool and nasal discharge from the toddler’s nose, changing diapers, kissing the child on the mouth – can transmit CMV,” he said. In addition, toddlers may acquire CMV from group day care; the child then sheds CMV and transmits the virus to their pregnant mother, who then transmits the virus across the placenta, leading to cCMV infection in the newborn, Dr. Schleiss explained.

Although the researchers expected a decrease in CMV in the wake of closures of group day care, increased home schooling, decreased interactions among children, hygienic precautions, and social isolation, the decrease exceeded their expectations, said Dr. Schleiss. “Our previous work showed that in the 5-year period leading up to the pandemic, about one baby in every 200 births was born with CMV. Between August 2020 and December 2021, the number decreased to one baby in every 1,000 births,” a difference he and his team found striking.

The message from the study is that CMV can be prevented, said Dr. Schleiss. “Hygienic precautions during pregnancy had a big impact. Since congenital CMV infection is the most common congenital infection in the United States, and probably globally, that causes disabilities in children, the implications are highly significant,” he said. “The hygienic precautions we all have engaged in during the pandemic, such as masking, handwashing, and infection prevention behaviors, were almost certainly responsible for the reduction in CMV transmission, which in turn protected mothers and newborns from the potentially devastating effects of the CMV virus,” he noted.

Looking ahead, “Vaccines are moving forward in clinical trials that aim to confer immunity on young women of childbearing age to protect future pregnancies against transmission of CMV to the newborn infant; it would be very important to examine in future studies whether hygienic precautions would have the same impact as a potential vaccine,” Dr. Schleiss said. More research is needed to examine the effect of education of women about CMV transmission, he added. “We think it is very important to share this knowledge from our study with the pediatric community, since pediatricians can be important in counseling women about future pregnancies and the risks of CMV acquisition and transmission,” he noted.

Implications for other viruses

Although CMV poses minimal risk for healthy populations, irreversible complications for infants born with congenital CMV, especially hearing loss, are very concerning, said Catherine Haut, DNP, CPNP-AC/PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview.

“The study of viral transmission during a time of isolation, masking, and other mitigation procedures for COVID-19 assists in awareness that other viruses may also be limited with the use of these measures,” she said.

Dr. Haut was not surprised by the findings, given that CMV is transmitted primarily through direct contact with body fluids and that more than 50% of American adults have been infected by age 40, according to the Centers for Disease Control and Prevention, she said.

The take-home message for pediatricians, Dr. Haut said, is measures to prevent transmission of viral infection can yield significant positive health outcomes for the pediatric population; however, the effect of isolation, which has been associated with a higher rate of mental health problems, should not be ignored.

“Despite appropriate statistical analyses and presentation of findings in this study, the population sampled during the pandemic was less than 30% of the pre-COVID sampling, representing a study limitation,” and conducting research in a single state limits generalizability, Dr. Haut noted. “I agree with the authors that additional study is necessary to better understand prevention measures and apply these methods to reduce CMV transmission. Pursuit of CMV immunization opportunities is also needed,” she said.

The study was supported by the Centers for Disease Control and Prevention, the National Vaccine Program Office, the Minnesota Department of Health Newborn Screening Program, and the University of South Carolina Disability Research and Dissemination Center. Lead author Dr. Schleiss disclosed grants from the CDC, the National Institutes of Health, and the DRDC during the conduct of the study; he also disclosed receiving personal fees from Moderna, Sanofi, GlaxoSmithKline, and Merck unrelated to the study. Dr. Haut had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

Congenital cytomegalovirus cases declined significantly during the COVID-19 pandemic, compared with a period before the pandemic, based on data from nearly 20,000 newborns.

A study originated to explore racial and ethnic differences in congenital cytomegalovirus (cCMV) began in 2016, but was halted in April 2020 because of the COVID-19 pandemic, wrote Mark R. Schleiss, MD, of the University of Minnesota, Minneapolis, and colleagues. The study resumed for a period from August 2020 to December 2021, and the researchers compared data on cCMV before and during the pandemic. The prepandemic period included data from April 2016 to March 2020.

“We have been screening for congenital CMV infection in Minnesota for 6 years as a part of a multicenter collaborative study that I lead as the primary investigator,” Dr. Schleiss said in an interview. “Our efforts have contributed to the decision, vetted through the Minnesota Legislature and signed into law in 2021 (the “Vivian Act”), to begin universal screening for all newborns in Minnesota in 2023. In the context of this ongoing screening/surveillance study, it was important and scientifically very interesting to examine the impact of the COVID-19 pandemic on the risk of congenital CMV infection,” he explained.

The findings were published in a research letter in JAMA Network Open. A total of 15,697 newborns were screened before the pandemic and 4,222 were screened during the pandemic period at six hospitals. The majority of the mothers participating during the prepandemic and pandemic periods were non-Hispanic White (71% and 60%, respectively).

Overall, the percentage screened prevalence for cCMV was 79% in the prepandemic period and 21% during the pandemic, with rates of 4.5 per 1,000 and 1.4 per 1,000, respectively.

Although the highest percentage of cCMV cases occurred in newborns of mothers aged 25 years and older (86%), the prevalence was highest among newborns of mothers aged 24 years and younger (6.0 per 1,000). The prevalence of cCMV overall was higher in infants of non-Hispanic Black mothers vs. non-Hispanic White mothers, but not significantly different (5.1 per 1,000 vs. 4.6 per 1,000) and among second newborns vs. first newborns (6.0 vs. 3.2 per 1,000, respectively).

Factors related to COVID-19, including reduced day care attendance, behavioral changes, and mitigation measures at childcare facilities such as smaller classes and increased hand hygiene and disinfection may have contributed to this decrease in cCMV in the pandemic period, the researchers wrote in their discussion.

The comparable prevalence in newborns of non-Hispanic Black and White mothers contrasts with previous studies showing a higher prevalence in children of non-Hispanic Black mothers, the researchers noted in their discussion.

The study was limited by several factors, including the variation in time points for enrollment at different sites and the exclusion of families in the newborn nursery with positive COVID-19 results during the pandemic, they wrote. More research is needed on the potential effects of behavioral interventions to reduce CMV risk during pregnancy, as well as future CMV vaccination for childbearing-aged women and young children, they concluded.

However, the researchers were surprised by the impact of COVID-19 on the prevalence of cCMV, Dr. Schleiss said in an interview. “We have had the knowledge for many years that CMV infections in young women are commonly acquired through interactions with their toddlers. These interactions – sharing food, wiping drool and nasal discharge from the toddler’s nose, changing diapers, kissing the child on the mouth – can transmit CMV,” he said. In addition, toddlers may acquire CMV from group day care; the child then sheds CMV and transmits the virus to their pregnant mother, who then transmits the virus across the placenta, leading to cCMV infection in the newborn, Dr. Schleiss explained.

Although the researchers expected a decrease in CMV in the wake of closures of group day care, increased home schooling, decreased interactions among children, hygienic precautions, and social isolation, the decrease exceeded their expectations, said Dr. Schleiss. “Our previous work showed that in the 5-year period leading up to the pandemic, about one baby in every 200 births was born with CMV. Between August 2020 and December 2021, the number decreased to one baby in every 1,000 births,” a difference he and his team found striking.

The message from the study is that CMV can be prevented, said Dr. Schleiss. “Hygienic precautions during pregnancy had a big impact. Since congenital CMV infection is the most common congenital infection in the United States, and probably globally, that causes disabilities in children, the implications are highly significant,” he said. “The hygienic precautions we all have engaged in during the pandemic, such as masking, handwashing, and infection prevention behaviors, were almost certainly responsible for the reduction in CMV transmission, which in turn protected mothers and newborns from the potentially devastating effects of the CMV virus,” he noted.

Looking ahead, “Vaccines are moving forward in clinical trials that aim to confer immunity on young women of childbearing age to protect future pregnancies against transmission of CMV to the newborn infant; it would be very important to examine in future studies whether hygienic precautions would have the same impact as a potential vaccine,” Dr. Schleiss said. More research is needed to examine the effect of education of women about CMV transmission, he added. “We think it is very important to share this knowledge from our study with the pediatric community, since pediatricians can be important in counseling women about future pregnancies and the risks of CMV acquisition and transmission,” he noted.

Implications for other viruses

Although CMV poses minimal risk for healthy populations, irreversible complications for infants born with congenital CMV, especially hearing loss, are very concerning, said Catherine Haut, DNP, CPNP-AC/PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview.

“The study of viral transmission during a time of isolation, masking, and other mitigation procedures for COVID-19 assists in awareness that other viruses may also be limited with the use of these measures,” she said.

Dr. Haut was not surprised by the findings, given that CMV is transmitted primarily through direct contact with body fluids and that more than 50% of American adults have been infected by age 40, according to the Centers for Disease Control and Prevention, she said.

The take-home message for pediatricians, Dr. Haut said, is measures to prevent transmission of viral infection can yield significant positive health outcomes for the pediatric population; however, the effect of isolation, which has been associated with a higher rate of mental health problems, should not be ignored.

“Despite appropriate statistical analyses and presentation of findings in this study, the population sampled during the pandemic was less than 30% of the pre-COVID sampling, representing a study limitation,” and conducting research in a single state limits generalizability, Dr. Haut noted. “I agree with the authors that additional study is necessary to better understand prevention measures and apply these methods to reduce CMV transmission. Pursuit of CMV immunization opportunities is also needed,” she said.

The study was supported by the Centers for Disease Control and Prevention, the National Vaccine Program Office, the Minnesota Department of Health Newborn Screening Program, and the University of South Carolina Disability Research and Dissemination Center. Lead author Dr. Schleiss disclosed grants from the CDC, the National Institutes of Health, and the DRDC during the conduct of the study; he also disclosed receiving personal fees from Moderna, Sanofi, GlaxoSmithKline, and Merck unrelated to the study. Dr. Haut had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) leads to improved birth outcomes and lower infant mortality, and possibly better preventive childcare, suggests new research.

How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.

The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.

The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.

All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.

“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”

Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.

Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
 

Growing evidence should drive enrollment

“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.

Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.

“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”

Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.

“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
 

Goals of future research

Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.

“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”

Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.

Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.

“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.

Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”

She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.

Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.

“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”

The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) leads to improved birth outcomes and lower infant mortality, and possibly better preventive childcare, suggests new research.

How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.

The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.

The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.

All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.

“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”

Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.

Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
 

Growing evidence should drive enrollment

“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.

Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.

“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”

Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.

“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
 

Goals of future research

Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.

“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”

Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.

Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.

“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.

Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”

She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.

Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.

“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”

The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) leads to improved birth outcomes and lower infant mortality, and possibly better preventive childcare, suggests new research.

How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.

The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.

The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.

All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.

“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”

Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.

Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
 

Growing evidence should drive enrollment

“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.

Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.

“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”

Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.

“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
 

Goals of future research

Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.

“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”

Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.

Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.

“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.

Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”

She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.

Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.

“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”

The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

Health charities called for action to address racial health disparities after population-wide analysis by the UK Health Security Agency found that Black and Asian neonates had a significantly higher risk of early-onset group B streptococcal disease (GBS), compared with White infants.

One support group said more research was now needed to identify the cause of the disparity, and called for pregnant women to be better informed about the disease and what it could mean for them and their baby.

The study, published in Pediatrics, used UKHSA data on laboratory-confirmed infant group B streptococcal (iGBS) disease cases between Jan. 1, 2016, and Dec. 31, 2020, and were linked to hospital ethnicity records.

Cases of iGBS were defined as isolation of Streptococcus agalactiae from a normally sterile site at 0-6 days of life for early-onset iGBS and 7-90 days for late-onset disease.
 

Hospital data and parent-reported ethnicity

Researchers found 2,512 iGBS cases in England during the study period, 65.3% were early onset and 34.8% late onset, equivalent to 0.52 and 0.28 cases per 1000 live births respectively.

Researchers were able to link 85.6% of those to ethnicity. Among those 2,149 cases, Black infants had a 48% higher risk, and Asian infants a 40% higher risk of early onset iGBS, compared with White infants. Among those from an Asian background, the risk was 87% higher for Bangladeshi and 38% higher for Pakistani neonates.

Rates of early onset iGBS per 1,000 live births were 0.43 for White infants, 0.63 for Black infants, and 0.60 for those of Asian ethnicity.

In contrast, Indian infants had an early-onset rate of 0.47 per 1,000 live births, which was similar to White infants.

Black infants had 57% higher rates of late-onset iGBS (0.37) than White infants (0.24), the researchers reported.

The study authors highlighted previous research which found higher prevalence of group B streptococcal colonization in mothers from Black and some Asian ethnic groups, but lower prevalence in mothers from the Indian subcontinent. More research was needed to establish causes, the researchers said, including whether higher preterm birth rates in minority ethnic groups led to increased iGBS risk in neonates, or whether maternal group B streptococcal disease led to higher preterm birth rates and subsequent neonatal iGBS.

The researchers concluded: “Understanding the factors underpinning differences in rates of early-onset iGBS within south Asian groups in England may lead to new opportunities for prevention such as prioritized antenatal screening. Strategies to prevent neonatal iGBS must be tailored from high-quality quantitative and qualitative data to reach all women and protect all infants, irrespective of racial or ethnic background.”
 

‘Shocking but not surprising’

Commenting on the study, Edward Morris, president of the Royal College of Obstetricians and Gynaecologists, said: “This research is striking reading, and is yet another example of how far we have to go to tackle health inequalities within women’s health care.”

Philip Steer, professor emeritus at Imperial College London, said that the results were “consistent with previous reports of higher GBS carriage and higher maternal and neonatal mortality rates in minority groups” and “emphasize the importance of studying not just whether, but why, these differences exist.” He added: “We need to understand the reasons for the differences before we can design much-needed intervention to eliminate them.”

Jane Plumb, chief executive of Group B Strep Support, called the findings “shocking, but unfortunately not surprising” and said that they offered “another example of racial disparities in maternal and neonatal health.” She said: “We’re calling for all pregnant women and birthing people to be informed about GBS and its risks, so they can make empowered choices for themselves and their baby. It is also critical that trusts sign up to take part in the internationally significant [National Institute for Health and Care Research]–funded GBS3 clinical trial, designed to improve the prevention of GBS infection.”

Baroness Shaista Gohir, chief executive of the Muslim Women’s Network, said: “With significantly higher rates of group B Strep infection in Black and Asian babies, greater efforts must be made to improve awareness among pregnant women within these communities.”

A version of this article first appeared on Medscape UK.

Health charities called for action to address racial health disparities after population-wide analysis by the UK Health Security Agency found that Black and Asian neonates had a significantly higher risk of early-onset group B streptococcal disease (GBS), compared with White infants.

One support group said more research was now needed to identify the cause of the disparity, and called for pregnant women to be better informed about the disease and what it could mean for them and their baby.

The study, published in Pediatrics, used UKHSA data on laboratory-confirmed infant group B streptococcal (iGBS) disease cases between Jan. 1, 2016, and Dec. 31, 2020, and were linked to hospital ethnicity records.

Cases of iGBS were defined as isolation of Streptococcus agalactiae from a normally sterile site at 0-6 days of life for early-onset iGBS and 7-90 days for late-onset disease.
 

Hospital data and parent-reported ethnicity

Researchers found 2,512 iGBS cases in England during the study period, 65.3% were early onset and 34.8% late onset, equivalent to 0.52 and 0.28 cases per 1000 live births respectively.

Researchers were able to link 85.6% of those to ethnicity. Among those 2,149 cases, Black infants had a 48% higher risk, and Asian infants a 40% higher risk of early onset iGBS, compared with White infants. Among those from an Asian background, the risk was 87% higher for Bangladeshi and 38% higher for Pakistani neonates.

Rates of early onset iGBS per 1,000 live births were 0.43 for White infants, 0.63 for Black infants, and 0.60 for those of Asian ethnicity.

In contrast, Indian infants had an early-onset rate of 0.47 per 1,000 live births, which was similar to White infants.

Black infants had 57% higher rates of late-onset iGBS (0.37) than White infants (0.24), the researchers reported.

The study authors highlighted previous research which found higher prevalence of group B streptococcal colonization in mothers from Black and some Asian ethnic groups, but lower prevalence in mothers from the Indian subcontinent. More research was needed to establish causes, the researchers said, including whether higher preterm birth rates in minority ethnic groups led to increased iGBS risk in neonates, or whether maternal group B streptococcal disease led to higher preterm birth rates and subsequent neonatal iGBS.

The researchers concluded: “Understanding the factors underpinning differences in rates of early-onset iGBS within south Asian groups in England may lead to new opportunities for prevention such as prioritized antenatal screening. Strategies to prevent neonatal iGBS must be tailored from high-quality quantitative and qualitative data to reach all women and protect all infants, irrespective of racial or ethnic background.”
 

‘Shocking but not surprising’

Commenting on the study, Edward Morris, president of the Royal College of Obstetricians and Gynaecologists, said: “This research is striking reading, and is yet another example of how far we have to go to tackle health inequalities within women’s health care.”

Philip Steer, professor emeritus at Imperial College London, said that the results were “consistent with previous reports of higher GBS carriage and higher maternal and neonatal mortality rates in minority groups” and “emphasize the importance of studying not just whether, but why, these differences exist.” He added: “We need to understand the reasons for the differences before we can design much-needed intervention to eliminate them.”

Jane Plumb, chief executive of Group B Strep Support, called the findings “shocking, but unfortunately not surprising” and said that they offered “another example of racial disparities in maternal and neonatal health.” She said: “We’re calling for all pregnant women and birthing people to be informed about GBS and its risks, so they can make empowered choices for themselves and their baby. It is also critical that trusts sign up to take part in the internationally significant [National Institute for Health and Care Research]–funded GBS3 clinical trial, designed to improve the prevention of GBS infection.”

Baroness Shaista Gohir, chief executive of the Muslim Women’s Network, said: “With significantly higher rates of group B Strep infection in Black and Asian babies, greater efforts must be made to improve awareness among pregnant women within these communities.”

A version of this article first appeared on Medscape UK.

Health charities called for action to address racial health disparities after population-wide analysis by the UK Health Security Agency found that Black and Asian neonates had a significantly higher risk of early-onset group B streptococcal disease (GBS), compared with White infants.

One support group said more research was now needed to identify the cause of the disparity, and called for pregnant women to be better informed about the disease and what it could mean for them and their baby.

The study, published in Pediatrics, used UKHSA data on laboratory-confirmed infant group B streptococcal (iGBS) disease cases between Jan. 1, 2016, and Dec. 31, 2020, and were linked to hospital ethnicity records.

Cases of iGBS were defined as isolation of Streptococcus agalactiae from a normally sterile site at 0-6 days of life for early-onset iGBS and 7-90 days for late-onset disease.
 

Hospital data and parent-reported ethnicity

Researchers found 2,512 iGBS cases in England during the study period, 65.3% were early onset and 34.8% late onset, equivalent to 0.52 and 0.28 cases per 1000 live births respectively.

Researchers were able to link 85.6% of those to ethnicity. Among those 2,149 cases, Black infants had a 48% higher risk, and Asian infants a 40% higher risk of early onset iGBS, compared with White infants. Among those from an Asian background, the risk was 87% higher for Bangladeshi and 38% higher for Pakistani neonates.

Rates of early onset iGBS per 1,000 live births were 0.43 for White infants, 0.63 for Black infants, and 0.60 for those of Asian ethnicity.

In contrast, Indian infants had an early-onset rate of 0.47 per 1,000 live births, which was similar to White infants.

Black infants had 57% higher rates of late-onset iGBS (0.37) than White infants (0.24), the researchers reported.

The study authors highlighted previous research which found higher prevalence of group B streptococcal colonization in mothers from Black and some Asian ethnic groups, but lower prevalence in mothers from the Indian subcontinent. More research was needed to establish causes, the researchers said, including whether higher preterm birth rates in minority ethnic groups led to increased iGBS risk in neonates, or whether maternal group B streptococcal disease led to higher preterm birth rates and subsequent neonatal iGBS.

The researchers concluded: “Understanding the factors underpinning differences in rates of early-onset iGBS within south Asian groups in England may lead to new opportunities for prevention such as prioritized antenatal screening. Strategies to prevent neonatal iGBS must be tailored from high-quality quantitative and qualitative data to reach all women and protect all infants, irrespective of racial or ethnic background.”
 

‘Shocking but not surprising’

Commenting on the study, Edward Morris, president of the Royal College of Obstetricians and Gynaecologists, said: “This research is striking reading, and is yet another example of how far we have to go to tackle health inequalities within women’s health care.”

Philip Steer, professor emeritus at Imperial College London, said that the results were “consistent with previous reports of higher GBS carriage and higher maternal and neonatal mortality rates in minority groups” and “emphasize the importance of studying not just whether, but why, these differences exist.” He added: “We need to understand the reasons for the differences before we can design much-needed intervention to eliminate them.”

Jane Plumb, chief executive of Group B Strep Support, called the findings “shocking, but unfortunately not surprising” and said that they offered “another example of racial disparities in maternal and neonatal health.” She said: “We’re calling for all pregnant women and birthing people to be informed about GBS and its risks, so they can make empowered choices for themselves and their baby. It is also critical that trusts sign up to take part in the internationally significant [National Institute for Health and Care Research]–funded GBS3 clinical trial, designed to improve the prevention of GBS infection.”

Baroness Shaista Gohir, chief executive of the Muslim Women’s Network, said: “With significantly higher rates of group B Strep infection in Black and Asian babies, greater efforts must be made to improve awareness among pregnant women within these communities.”

A version of this article first appeared on Medscape UK.

A new study of educational attainment among U.K. primary and secondary schoolchildren born prematurely now provides some reassurance about the longer-term outcomes for many of these children.

For the study, published in the open-access journal PLOS ONE, researchers from the University of Oxford with colleagues from the University of Leicester and City University, London, used data from 11,695 children in the population-based UK Millennium Cohort Study, which included children born in England from Sept. 1, 2000 to Aug. 31, 2001. They analyzed data on educational attainment in primary school, at age 11, for 6,950 pupils and in secondary school, at age 16, for 7,131 pupils.

Preterm birth is a known risk factor for developmental impairment, lower educational performance and reduced academic attainment, with the impact proportional to the degree of prematurity. Not every child born prematurely will experience learning or developmental challenges, but studies of children born before 34 weeks gestation have shown that they are more likely to have cognitive difficulties, particularly poorer reading and maths skills, at primary school, and to have special educational needs by the end of primary education.
 

Elevated risk of all preterm children in primary school

Until now, few studies have followed these children through secondary school or examined the full spectrum of gestational ages at birth. Yet as neonatal care advances and more premature babies now survive, an average primary class in the United Kingdom now includes two preterm children.

Among the primary school children overall, 17.7% had not achieved their expected level in English and mathematics at age 11. Children born very preterm, before 32 weeks or at 32-33 weeks gestation, were more than twice as likely as full term children to fail to meet these benchmarks, with adjusted relative risks of 2.06 and 2.13, respectively. Those born late preterm, at 34-36 weeks, or early term, at 37-38 weeks, were at lesser risk, with RRs of 1.18 and 1.21, respectively.

By the end of secondary school, 45.2% of pupils had not passed the benchmark of at least five General Certificate of Secondary Education (GCSE) examinations, including English and mathematics. The RR for children born very preterm, compared with full term children, was 1.26, with 60% of students in this group failing to achieve five GCSEs. However, children born at gestations between 32 and 38 weeks were not at elevated risk, compared with children born at full term.
 

Risk persists to secondary level only for very preterm children

A similar pattern was seen with English and mathematics analyzed separately, with no additional risk of not passing among children born at 32 weeks or above, but adjusted RRs of 1.33 for not passing English and 1.42 for not passing maths among pupils who had been born very preterm, compared with full term children.

“All children born before full term are more likely to have poorer attainment during primary school, compared with children born full term (39-41 weeks), but only children born very preterm (before 32 weeks) remain at risk of poor attainment at the end of secondary schooling,” the researchers concluded.

“Further studies are needed in order to confirm this result,” they acknowledge. They suggested their results could be explained by catch-up in academic attainment among children born moderately or late preterm or at early term. However, “very preterm children appear to be a high-risk group with persistent difficulties in terms of educational outcomes,” they said, noting that even this risk was of lower magnitude than the reduced attainment scores they found among pupils eligible for free school meals, meaning those from disadvantaged socioeconomic backgrounds.
 

Extra educational support needed

The researchers concluded: “Children born very preterm may benefit from screening for cognitive and language difficulties prior to school entry to guide the provision of additional support during schooling.” In addition, those born very preterm “may require additional educational support throughout compulsory schooling.”

Commenting on the study, Caroline Lee-Davey, chief executive of premature baby charity Bliss, told this news organization: “Every child who is born premature is unique, and their development and achievements will be individual to them. However, these new findings are significant and add to our understanding of how prematurity is related to longer-term educational attainment, particularly for children who were born very preterm.”

“Most importantly, they highlight the need for all children who were born premature – and particularly those who were born before 32 weeks – to have access to early support. This means ensuring all eligible babies receive a follow-up check at 2 and 4 years as recommended by NICE and for early years and educational professionals to be aware of the relationship between premature birth and development.”

“We know how concerning these findings might be for families with babies and very young children right now. That’s why Bliss has developed a suite of information to support families as they make choices about their child’s education.”

A version of this article first appeared on Medscape UK.

A new study of educational attainment among U.K. primary and secondary schoolchildren born prematurely now provides some reassurance about the longer-term outcomes for many of these children.

For the study, published in the open-access journal PLOS ONE, researchers from the University of Oxford with colleagues from the University of Leicester and City University, London, used data from 11,695 children in the population-based UK Millennium Cohort Study, which included children born in England from Sept. 1, 2000 to Aug. 31, 2001. They analyzed data on educational attainment in primary school, at age 11, for 6,950 pupils and in secondary school, at age 16, for 7,131 pupils.

Preterm birth is a known risk factor for developmental impairment, lower educational performance and reduced academic attainment, with the impact proportional to the degree of prematurity. Not every child born prematurely will experience learning or developmental challenges, but studies of children born before 34 weeks gestation have shown that they are more likely to have cognitive difficulties, particularly poorer reading and maths skills, at primary school, and to have special educational needs by the end of primary education.
 

Elevated risk of all preterm children in primary school

Until now, few studies have followed these children through secondary school or examined the full spectrum of gestational ages at birth. Yet as neonatal care advances and more premature babies now survive, an average primary class in the United Kingdom now includes two preterm children.

Among the primary school children overall, 17.7% had not achieved their expected level in English and mathematics at age 11. Children born very preterm, before 32 weeks or at 32-33 weeks gestation, were more than twice as likely as full term children to fail to meet these benchmarks, with adjusted relative risks of 2.06 and 2.13, respectively. Those born late preterm, at 34-36 weeks, or early term, at 37-38 weeks, were at lesser risk, with RRs of 1.18 and 1.21, respectively.

By the end of secondary school, 45.2% of pupils had not passed the benchmark of at least five General Certificate of Secondary Education (GCSE) examinations, including English and mathematics. The RR for children born very preterm, compared with full term children, was 1.26, with 60% of students in this group failing to achieve five GCSEs. However, children born at gestations between 32 and 38 weeks were not at elevated risk, compared with children born at full term.
 

Risk persists to secondary level only for very preterm children

A similar pattern was seen with English and mathematics analyzed separately, with no additional risk of not passing among children born at 32 weeks or above, but adjusted RRs of 1.33 for not passing English and 1.42 for not passing maths among pupils who had been born very preterm, compared with full term children.

“All children born before full term are more likely to have poorer attainment during primary school, compared with children born full term (39-41 weeks), but only children born very preterm (before 32 weeks) remain at risk of poor attainment at the end of secondary schooling,” the researchers concluded.

“Further studies are needed in order to confirm this result,” they acknowledge. They suggested their results could be explained by catch-up in academic attainment among children born moderately or late preterm or at early term. However, “very preterm children appear to be a high-risk group with persistent difficulties in terms of educational outcomes,” they said, noting that even this risk was of lower magnitude than the reduced attainment scores they found among pupils eligible for free school meals, meaning those from disadvantaged socioeconomic backgrounds.
 

Extra educational support needed

The researchers concluded: “Children born very preterm may benefit from screening for cognitive and language difficulties prior to school entry to guide the provision of additional support during schooling.” In addition, those born very preterm “may require additional educational support throughout compulsory schooling.”

Commenting on the study, Caroline Lee-Davey, chief executive of premature baby charity Bliss, told this news organization: “Every child who is born premature is unique, and their development and achievements will be individual to them. However, these new findings are significant and add to our understanding of how prematurity is related to longer-term educational attainment, particularly for children who were born very preterm.”

“Most importantly, they highlight the need for all children who were born premature – and particularly those who were born before 32 weeks – to have access to early support. This means ensuring all eligible babies receive a follow-up check at 2 and 4 years as recommended by NICE and for early years and educational professionals to be aware of the relationship between premature birth and development.”

“We know how concerning these findings might be for families with babies and very young children right now. That’s why Bliss has developed a suite of information to support families as they make choices about their child’s education.”

A version of this article first appeared on Medscape UK.

A new study of educational attainment among U.K. primary and secondary schoolchildren born prematurely now provides some reassurance about the longer-term outcomes for many of these children.

For the study, published in the open-access journal PLOS ONE, researchers from the University of Oxford with colleagues from the University of Leicester and City University, London, used data from 11,695 children in the population-based UK Millennium Cohort Study, which included children born in England from Sept. 1, 2000 to Aug. 31, 2001. They analyzed data on educational attainment in primary school, at age 11, for 6,950 pupils and in secondary school, at age 16, for 7,131 pupils.

Preterm birth is a known risk factor for developmental impairment, lower educational performance and reduced academic attainment, with the impact proportional to the degree of prematurity. Not every child born prematurely will experience learning or developmental challenges, but studies of children born before 34 weeks gestation have shown that they are more likely to have cognitive difficulties, particularly poorer reading and maths skills, at primary school, and to have special educational needs by the end of primary education.
 

Elevated risk of all preterm children in primary school

Until now, few studies have followed these children through secondary school or examined the full spectrum of gestational ages at birth. Yet as neonatal care advances and more premature babies now survive, an average primary class in the United Kingdom now includes two preterm children.

Among the primary school children overall, 17.7% had not achieved their expected level in English and mathematics at age 11. Children born very preterm, before 32 weeks or at 32-33 weeks gestation, were more than twice as likely as full term children to fail to meet these benchmarks, with adjusted relative risks of 2.06 and 2.13, respectively. Those born late preterm, at 34-36 weeks, or early term, at 37-38 weeks, were at lesser risk, with RRs of 1.18 and 1.21, respectively.

By the end of secondary school, 45.2% of pupils had not passed the benchmark of at least five General Certificate of Secondary Education (GCSE) examinations, including English and mathematics. The RR for children born very preterm, compared with full term children, was 1.26, with 60% of students in this group failing to achieve five GCSEs. However, children born at gestations between 32 and 38 weeks were not at elevated risk, compared with children born at full term.
 

Risk persists to secondary level only for very preterm children

A similar pattern was seen with English and mathematics analyzed separately, with no additional risk of not passing among children born at 32 weeks or above, but adjusted RRs of 1.33 for not passing English and 1.42 for not passing maths among pupils who had been born very preterm, compared with full term children.

“All children born before full term are more likely to have poorer attainment during primary school, compared with children born full term (39-41 weeks), but only children born very preterm (before 32 weeks) remain at risk of poor attainment at the end of secondary schooling,” the researchers concluded.

“Further studies are needed in order to confirm this result,” they acknowledge. They suggested their results could be explained by catch-up in academic attainment among children born moderately or late preterm or at early term. However, “very preterm children appear to be a high-risk group with persistent difficulties in terms of educational outcomes,” they said, noting that even this risk was of lower magnitude than the reduced attainment scores they found among pupils eligible for free school meals, meaning those from disadvantaged socioeconomic backgrounds.
 

Extra educational support needed

The researchers concluded: “Children born very preterm may benefit from screening for cognitive and language difficulties prior to school entry to guide the provision of additional support during schooling.” In addition, those born very preterm “may require additional educational support throughout compulsory schooling.”

Commenting on the study, Caroline Lee-Davey, chief executive of premature baby charity Bliss, told this news organization: “Every child who is born premature is unique, and their development and achievements will be individual to them. However, these new findings are significant and add to our understanding of how prematurity is related to longer-term educational attainment, particularly for children who were born very preterm.”

“Most importantly, they highlight the need for all children who were born premature – and particularly those who were born before 32 weeks – to have access to early support. This means ensuring all eligible babies receive a follow-up check at 2 and 4 years as recommended by NICE and for early years and educational professionals to be aware of the relationship between premature birth and development.”

“We know how concerning these findings might be for families with babies and very young children right now. That’s why Bliss has developed a suite of information to support families as they make choices about their child’s education.”

A version of this article first appeared on Medscape UK.

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

An overwhelmed mother presents to your office with her 2-month-old son for his check-up. She seems distant and dysphoric, often shrugging her shoulders with an empty stare when asked about her son’s development. Her baby cries loudly in her arms and you can see that she is uncomfortable soothing him as she frantically rocks him back and forth. He appears to have gained little weight since the last appointment occurring 6 days post partum and his mother describes him as “difficult and fussy all the time.” The father was unable to attend the appointment due to work obligations and often leaves the baby alone with the mother for 10 hours per day. As you examine her son, you counsel the mother on how to care for her baby while also caring for herself. The mother immediately begins to sob into her hands and states: “I can’t do this anymore. I am not meant to be a mother.”

Major depressive disorder with peripartum onset – also known as postpartum depression – is a major public health concern that affects approximately 20% of women in industrial societies like the United States. It is among the most prevalent psychiatric disorders in the world and remains largely underdiagnosed because of lack of access to care, symptom underreporting secondary to stigma, and lack of education regarding illness.¹ Adequate treatment of perinatal depression is of paramount importance, as this condition can have significant negative consequences for both mother and child.

Infants raised by depressed mothers show early disruptions in social and emotional development, including diminished security of attachment with their mothers and reduced ability to self-regulate.² Later in development, the offspring of depressed mothers are at greater risk for psychopathology – most notably anxiety and depression as well as impaired social behavior. ^3,4 Rates of depression in school-aged and adolescent children of depressed mothers have been reported to be between 20% and 41%.⁴ Not only are rates of depression higher, but depression in children of depressed parents, relative to depression in same-age children of nondepressed parents, has an earlier age of onset, longer duration, and is associated with greater functional impairment and risk of relapse.⁵

In addition, evidence shows that infants of depressed mothers show more negative affect and more self-directed regulatory behaviors, while toddlers show more dysregulated aggression and heightened mood lability.⁶ Given that these infants also already have an increased genetic risk for depression and anxiety, it is essential that mothers are identified and treated early to prevent these early disruptions to the parent-child relationship.

Pediatricians sit at the intersection of motherhood and infant development. This offers a unique opportunity to influence the trajectory of the child through bolstering supports for the mother. Understandably, time is limited during these brief touchpoints occurring over the first postpartum year, although a heartfelt “How are you?” can make all the difference. In asking this simple question in a disarming way, you may prevent multiple adverse childhood experiences for your tiniest patients.

Further, evidence has shown that toxic stress experienced during sensitive periods of brain development in infants and young children can negatively affect brain architecture. Brain pathways that are rarely used are pruned away, whereas pathways that are readily accessed grow stronger. If children are exposed to toxic stress, whether it be from abuse, mental illness of a caregiver such as severe maternal depression, witnessed domestic violence, or worse, they may begin to experience the world as dangerous and uncertain. This can strengthen connections in parts of the brain associated with fear, arousal, and emotional regulation at the cost of other parts of the brain associated with learning and safety.

Particularly focusing on infancy through preschool, children depend on sensitive, responsive caregivers to learn how to understand emotions and begin to self-soothe. Pediatricians have access to this critical period and can help lead the way toward secure attachment between mother and child. Through taking this dyadic, integrated approach, not only can downstream problems in the child be attenuated or even prevented (that is, disrupted social-emotional development and depression/anxiety), but a mother’s identity can form around her strengths in parenting rather than negative cognitive distortions. Here are some ways to quickly assess a mother for major depressive disorder with peripartum onset so that treatment can be secured, allowing children to develop and learn in a safe, supportive, loving environment:

• Add a standardized instrument to the check-in process during baby’s first year of life. The Edinburgh Postnatal Depression Scale (EPDS) is the most commonly used screening tool, consisting of 10 questions with a score of 10 or greater suggestive of maternal depression. Recently, it was found that the EPDS may be further abbreviated to a three-question version with a sensitivity of 95% and a negative predictive value of 98%.
• Dedicate 5 minutes during each appointment to ask the mother, in earnest, how she is doing and to create space to hear her concerns. This high-yield discussion can be the catalyst the mother needs to identify that something is not right.
• Obtain collateral information from the mother’s partner, if available, in a way that feels collaborative and supportive. You may ask the partner during the appointment if they have any concerns about how both parents are coping with their new parenting roles.
• If the mother has multiple risk factors for major depressive disorder with peripartum onset – past history of depression, family history of perinatal depression, lack of social supports, or past history of major depressive disorder with peripartum onset with an earlier child (elevating their risk to about 50%) – you may dedicate a bit more time to assess the patient and/or provide mental health resources directly upon wrapping up the appointment.
• Finally, you may add an educational blurb about major depressive disorder with peripartum onset in all after-visit summaries for new parents and infants with a list of mental health resources that includes reproductive psychiatrists, therapists, and a link to robust resources like Postpartum Support International.

By taking the extra step to leverage the relationship between mother and infant at this highly vulnerable time, you have the ability to positively affect the trajectory of a family. And, at the end of the day, this dyadic approach to patient care is the secret ingredient to improved outcomes all around.

References

1. Muzik M and Hamilton SE. Matern Child Health J. 2016;20(11):2268-79.

2. Granat A et al. Emotion. 2017;17(1):11-27.

3. Conroy S et al. J Am Acad Child Adolesc Psychiatry. 2012;51(1):51-61.

4. Goodman SH. Annu Rev Clin Psychol. 2007;3:107-35.

5. Keller MB et al. Arch Gen Psychiatry. 1986;43(10):930-7.

6. Tronick EZ and Gianino AF. New Dir Child Dev. 1986;34:5-11.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.

An overwhelmed mother presents to your office with her 2-month-old son for his check-up. She seems distant and dysphoric, often shrugging her shoulders with an empty stare when asked about her son’s development. Her baby cries loudly in her arms and you can see that she is uncomfortable soothing him as she frantically rocks him back and forth. He appears to have gained little weight since the last appointment occurring 6 days post partum and his mother describes him as “difficult and fussy all the time.” The father was unable to attend the appointment due to work obligations and often leaves the baby alone with the mother for 10 hours per day. As you examine her son, you counsel the mother on how to care for her baby while also caring for herself. The mother immediately begins to sob into her hands and states: “I can’t do this anymore. I am not meant to be a mother.”

Major depressive disorder with peripartum onset – also known as postpartum depression – is a major public health concern that affects approximately 20% of women in industrial societies like the United States. It is among the most prevalent psychiatric disorders in the world and remains largely underdiagnosed because of lack of access to care, symptom underreporting secondary to stigma, and lack of education regarding illness.¹ Adequate treatment of perinatal depression is of paramount importance, as this condition can have significant negative consequences for both mother and child.

Infants raised by depressed mothers show early disruptions in social and emotional development, including diminished security of attachment with their mothers and reduced ability to self-regulate.² Later in development, the offspring of depressed mothers are at greater risk for psychopathology – most notably anxiety and depression as well as impaired social behavior. ^3,4 Rates of depression in school-aged and adolescent children of depressed mothers have been reported to be between 20% and 41%.⁴ Not only are rates of depression higher, but depression in children of depressed parents, relative to depression in same-age children of nondepressed parents, has an earlier age of onset, longer duration, and is associated with greater functional impairment and risk of relapse.⁵

In addition, evidence shows that infants of depressed mothers show more negative affect and more self-directed regulatory behaviors, while toddlers show more dysregulated aggression and heightened mood lability.⁶ Given that these infants also already have an increased genetic risk for depression and anxiety, it is essential that mothers are identified and treated early to prevent these early disruptions to the parent-child relationship.

Pediatricians sit at the intersection of motherhood and infant development. This offers a unique opportunity to influence the trajectory of the child through bolstering supports for the mother. Understandably, time is limited during these brief touchpoints occurring over the first postpartum year, although a heartfelt “How are you?” can make all the difference. In asking this simple question in a disarming way, you may prevent multiple adverse childhood experiences for your tiniest patients.

Further, evidence has shown that toxic stress experienced during sensitive periods of brain development in infants and young children can negatively affect brain architecture. Brain pathways that are rarely used are pruned away, whereas pathways that are readily accessed grow stronger. If children are exposed to toxic stress, whether it be from abuse, mental illness of a caregiver such as severe maternal depression, witnessed domestic violence, or worse, they may begin to experience the world as dangerous and uncertain. This can strengthen connections in parts of the brain associated with fear, arousal, and emotional regulation at the cost of other parts of the brain associated with learning and safety.

Particularly focusing on infancy through preschool, children depend on sensitive, responsive caregivers to learn how to understand emotions and begin to self-soothe. Pediatricians have access to this critical period and can help lead the way toward secure attachment between mother and child. Through taking this dyadic, integrated approach, not only can downstream problems in the child be attenuated or even prevented (that is, disrupted social-emotional development and depression/anxiety), but a mother’s identity can form around her strengths in parenting rather than negative cognitive distortions. Here are some ways to quickly assess a mother for major depressive disorder with peripartum onset so that treatment can be secured, allowing children to develop and learn in a safe, supportive, loving environment:

• Add a standardized instrument to the check-in process during baby’s first year of life. The Edinburgh Postnatal Depression Scale (EPDS) is the most commonly used screening tool, consisting of 10 questions with a score of 10 or greater suggestive of maternal depression. Recently, it was found that the EPDS may be further abbreviated to a three-question version with a sensitivity of 95% and a negative predictive value of 98%.
• Dedicate 5 minutes during each appointment to ask the mother, in earnest, how she is doing and to create space to hear her concerns. This high-yield discussion can be the catalyst the mother needs to identify that something is not right.
• Obtain collateral information from the mother’s partner, if available, in a way that feels collaborative and supportive. You may ask the partner during the appointment if they have any concerns about how both parents are coping with their new parenting roles.
• If the mother has multiple risk factors for major depressive disorder with peripartum onset – past history of depression, family history of perinatal depression, lack of social supports, or past history of major depressive disorder with peripartum onset with an earlier child (elevating their risk to about 50%) – you may dedicate a bit more time to assess the patient and/or provide mental health resources directly upon wrapping up the appointment.
• Finally, you may add an educational blurb about major depressive disorder with peripartum onset in all after-visit summaries for new parents and infants with a list of mental health resources that includes reproductive psychiatrists, therapists, and a link to robust resources like Postpartum Support International.

By taking the extra step to leverage the relationship between mother and infant at this highly vulnerable time, you have the ability to positively affect the trajectory of a family. And, at the end of the day, this dyadic approach to patient care is the secret ingredient to improved outcomes all around.

References

1. Muzik M and Hamilton SE. Matern Child Health J. 2016;20(11):2268-79.

2. Granat A et al. Emotion. 2017;17(1):11-27.

3. Conroy S et al. J Am Acad Child Adolesc Psychiatry. 2012;51(1):51-61.

4. Goodman SH. Annu Rev Clin Psychol. 2007;3:107-35.

5. Keller MB et al. Arch Gen Psychiatry. 1986;43(10):930-7.

6. Tronick EZ and Gianino AF. New Dir Child Dev. 1986;34:5-11.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.

An overwhelmed mother presents to your office with her 2-month-old son for his check-up. She seems distant and dysphoric, often shrugging her shoulders with an empty stare when asked about her son’s development. Her baby cries loudly in her arms and you can see that she is uncomfortable soothing him as she frantically rocks him back and forth. He appears to have gained little weight since the last appointment occurring 6 days post partum and his mother describes him as “difficult and fussy all the time.” The father was unable to attend the appointment due to work obligations and often leaves the baby alone with the mother for 10 hours per day. As you examine her son, you counsel the mother on how to care for her baby while also caring for herself. The mother immediately begins to sob into her hands and states: “I can’t do this anymore. I am not meant to be a mother.”

Major depressive disorder with peripartum onset – also known as postpartum depression – is a major public health concern that affects approximately 20% of women in industrial societies like the United States. It is among the most prevalent psychiatric disorders in the world and remains largely underdiagnosed because of lack of access to care, symptom underreporting secondary to stigma, and lack of education regarding illness.¹ Adequate treatment of perinatal depression is of paramount importance, as this condition can have significant negative consequences for both mother and child.

Infants raised by depressed mothers show early disruptions in social and emotional development, including diminished security of attachment with their mothers and reduced ability to self-regulate.² Later in development, the offspring of depressed mothers are at greater risk for psychopathology – most notably anxiety and depression as well as impaired social behavior. ^3,4 Rates of depression in school-aged and adolescent children of depressed mothers have been reported to be between 20% and 41%.⁴ Not only are rates of depression higher, but depression in children of depressed parents, relative to depression in same-age children of nondepressed parents, has an earlier age of onset, longer duration, and is associated with greater functional impairment and risk of relapse.⁵

In addition, evidence shows that infants of depressed mothers show more negative affect and more self-directed regulatory behaviors, while toddlers show more dysregulated aggression and heightened mood lability.⁶ Given that these infants also already have an increased genetic risk for depression and anxiety, it is essential that mothers are identified and treated early to prevent these early disruptions to the parent-child relationship.

Pediatricians sit at the intersection of motherhood and infant development. This offers a unique opportunity to influence the trajectory of the child through bolstering supports for the mother. Understandably, time is limited during these brief touchpoints occurring over the first postpartum year, although a heartfelt “How are you?” can make all the difference. In asking this simple question in a disarming way, you may prevent multiple adverse childhood experiences for your tiniest patients.

Further, evidence has shown that toxic stress experienced during sensitive periods of brain development in infants and young children can negatively affect brain architecture. Brain pathways that are rarely used are pruned away, whereas pathways that are readily accessed grow stronger. If children are exposed to toxic stress, whether it be from abuse, mental illness of a caregiver such as severe maternal depression, witnessed domestic violence, or worse, they may begin to experience the world as dangerous and uncertain. This can strengthen connections in parts of the brain associated with fear, arousal, and emotional regulation at the cost of other parts of the brain associated with learning and safety.

Particularly focusing on infancy through preschool, children depend on sensitive, responsive caregivers to learn how to understand emotions and begin to self-soothe. Pediatricians have access to this critical period and can help lead the way toward secure attachment between mother and child. Through taking this dyadic, integrated approach, not only can downstream problems in the child be attenuated or even prevented (that is, disrupted social-emotional development and depression/anxiety), but a mother’s identity can form around her strengths in parenting rather than negative cognitive distortions. Here are some ways to quickly assess a mother for major depressive disorder with peripartum onset so that treatment can be secured, allowing children to develop and learn in a safe, supportive, loving environment:

• Add a standardized instrument to the check-in process during baby’s first year of life. The Edinburgh Postnatal Depression Scale (EPDS) is the most commonly used screening tool, consisting of 10 questions with a score of 10 or greater suggestive of maternal depression. Recently, it was found that the EPDS may be further abbreviated to a three-question version with a sensitivity of 95% and a negative predictive value of 98%.
• Dedicate 5 minutes during each appointment to ask the mother, in earnest, how she is doing and to create space to hear her concerns. This high-yield discussion can be the catalyst the mother needs to identify that something is not right.
• Obtain collateral information from the mother’s partner, if available, in a way that feels collaborative and supportive. You may ask the partner during the appointment if they have any concerns about how both parents are coping with their new parenting roles.
• If the mother has multiple risk factors for major depressive disorder with peripartum onset – past history of depression, family history of perinatal depression, lack of social supports, or past history of major depressive disorder with peripartum onset with an earlier child (elevating their risk to about 50%) – you may dedicate a bit more time to assess the patient and/or provide mental health resources directly upon wrapping up the appointment.
• Finally, you may add an educational blurb about major depressive disorder with peripartum onset in all after-visit summaries for new parents and infants with a list of mental health resources that includes reproductive psychiatrists, therapists, and a link to robust resources like Postpartum Support International.

By taking the extra step to leverage the relationship between mother and infant at this highly vulnerable time, you have the ability to positively affect the trajectory of a family. And, at the end of the day, this dyadic approach to patient care is the secret ingredient to improved outcomes all around.

References

1. Muzik M and Hamilton SE. Matern Child Health J. 2016;20(11):2268-79.

2. Granat A et al. Emotion. 2017;17(1):11-27.

3. Conroy S et al. J Am Acad Child Adolesc Psychiatry. 2012;51(1):51-61.

4. Goodman SH. Annu Rev Clin Psychol. 2007;3:107-35.

5. Keller MB et al. Arch Gen Psychiatry. 1986;43(10):930-7.

6. Tronick EZ and Gianino AF. New Dir Child Dev. 1986;34:5-11.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.

Raising phototherapy thresholds and revising risk assessment are among the key changes in the American Academy of Pediatrics’ updated guidelines for managing hyperbilirubinemia in infants 35 weeks’ gestation and older.

“More than 80% of newborn infants will have some degree of jaundice,” Alex R. Kemper, MD, of Nationwide Children’s Hospital, Columbus, Ohio, and coauthors wrote. Careful monitoring is needed manage high bilirubin concentrations and avoid acute bilirubin encephalopathy (ABE) and kernicterus, a disabling neurologic condition.

The current revision, published in Pediatrics, updates and replaces the 2004 AAP clinical practice guidelines for the management and prevention of hyperbilirubinemia in newborns of at least 35 weeks’ gestation.

The guideline committee reviewed evidence published since the previous guidelines were issued in 2004, and addressed similar issues of prevention, risk assessment, monitoring, and treatment.

A notable change from 2004 was the inclusion of a 2009 recommendation update for “universal predischarge bilirubin screening with measures of total serum bilirubin (TSB) or transcutaneous bilirubin (TcB) linked to specific recommendations for follow-up,” the authors wrote.

In terms of prevention, recommendations include a direct antiglobulin test (DAT) for infants whose mother’s antibody screen was positive or unknown. In addition, exclusive breastfeeding is known to be associated with hyperbilirubinemia, but clinicians should support breastfeeding while monitoring for signs of hyperbilirubinemia because of suboptimal feeding, the authors noted. However, the guidelines recommend against oral supplementation with water or dextrose water to prevent hyperbilirubinemia.

For assessment and monitoring, the guidelines advise the use of total serum bilirubin (TSB) as the definitive test for hyperbilirubinemia to guide phototherapy and escalation of care, including exchange transfusion. “The presence of hyperbilirubinemia neurotoxicity risk factors lowers the threshold for treatment with phototherapy and the level at which care should be escalated,” the authors wrote. They also emphasized the need to consider glucose-6-phosphate dehydrogenase deficiency, a genetic condition that decreases protection against oxidative stress and has been identified as a leading cause of hazardous hyperbilirubinemia worldwide.

The guidelines recommend assessing all infants for jaundice at least every 12 hours after delivery until discharge, with TSB or TcB measured as soon as possible for those with suspected jaundice. The complete guidelines include charts for TSB levels to guide escalation of care. “Blood for TSB can be obtained at the time it is collected for newborn screening tests to avoid an additional heel stick,” the authors noted.

The rate of increase in TSB or TcB, if more than one measure is available, may identify infants at higher risk of hyperbilirubinemia, according to the guidelines, and a possible delay of hospital discharge may be needed for infants if appropriate follow-up is not feasible.

In terms of treatment, new evidence that bilirubin neurotoxicity does not occur until concentrations well above those given in the 2004 guidelines justified raising the treatment thresholds, although by a narrow range. “With the increased phototherapy thresholds, appropriately following the current guidelines including bilirubin screening during the birth hospitalization and timely postdischarge follow-up is important,” the authors wrote. The new thresholds, outlined in the complete guidelines, are based on gestational age, hyperbilirubinemia neurotoxicity risk factors, and the age of the infant in hours. However, infants may be treated at lower levels, based on individual circumstances, family preferences, and shared decision-making with clinicians. Home-based phototherapy may be used in some infants, but should not be used if there is a question about the device quality, delivery time, and ability of caregivers to use the device correctly.

“Discontinuing phototherapy is an option when the TSB has decreased by at least 2 mg/dL below the hour-specific threshold at the initiation of phototherapy,” and follow-up should be based on risk of rebound hyperbilirubinemia, according to the guidelines.

“This clinical practice guideline provides indications and approaches for phototherapy and escalation of care and when treatment and monitoring can be safely discontinued,” However, clinicians should understand the rationale for the recommendations and combine them with their clinical judgment, including shared decision-making when appropriate, the authors concluded.
 

Updated evidence supports escalating care

The take-home message for pediatricians is that neonatal hyperbilirubinemia is a very common finding, and complications are rare, but the condition can result in devastating life-long results, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Previous guidelines published in 2004 and updated in 2009 included evidence-based recommendations, but additional research was still needed to provide guidance for providers to prevent complications of hyperbilirubinemia,” said Dr. Haut, who was not involved in producing the guidelines.

“New data documenting additional risk factors, the importance of ongoing breastfeeding support, and addressing hyperbilirubinemia as an urgent problem” are additions to prevention methods in the latest published guidelines, she said.

“Acute encephalopathy and kernicterus can result from hyperbilirubinemia with severe and devastating neurologic effects, but are preventable by early identification and treatment,” said Dr. Haut. Therefore, “it is not surprising that the AAP utilized continuing and more recent evidence to support new recommendations. Both maternal and neonatal risk factors have long been considered in the development of neonatal hyperbilirubinemia, but recent recommendations incorporate additional risk factor evaluation and urgency in time to appropriate care. Detailed thresholds for phototherapy and exchange transfusion will benefit the families of full-term infants without other risk factors and escalate care for those neonates with risk factors.”

However, potential barriers to following the guidelines persist, Dr. Haut noted.

“Frequent infant follow-up can be challenging for busy primary care offices with outpatient laboratory results often taking much longer to obtain than in a hospital setting,” she said.

Also, “taking a newborn to the emergency department or an inpatient laboratory can be frightening for families with the risk of illness exposure. Frequent monitoring of serum bilirubin levels is disturbing for parents and inconvenient immediately postpartum,” Dr. Haut explained. “Few practices utilize transcutaneous bilirubin monitoring which may be one method of added screening.”

In addition, “despite the importance of breastfeeding, ongoing support is not readily available for mothers after hospital discharge. A lactation specialist in the office setting can take the burden off providers and add opportunity for family education.”

As for additional research, “continued evaluation of the comparison of transcutaneous bilirubin monitoring and serum levels along with the use of transcutaneous monitoring in facilities outside the hospital setting may be warranted,” Dr. Haut said. “Data collection on incidence and accompanying risk factors of neonates who develop acute hyperbilirubinemia encephalopathy and kernicterus is a long-term study opportunity.”

The guidelines received no external funding. Lead author Dr. Kemper had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Raising phototherapy thresholds and revising risk assessment are among the key changes in the American Academy of Pediatrics’ updated guidelines for managing hyperbilirubinemia in infants 35 weeks’ gestation and older.

“More than 80% of newborn infants will have some degree of jaundice,” Alex R. Kemper, MD, of Nationwide Children’s Hospital, Columbus, Ohio, and coauthors wrote. Careful monitoring is needed manage high bilirubin concentrations and avoid acute bilirubin encephalopathy (ABE) and kernicterus, a disabling neurologic condition.

The current revision, published in Pediatrics, updates and replaces the 2004 AAP clinical practice guidelines for the management and prevention of hyperbilirubinemia in newborns of at least 35 weeks’ gestation.

The guideline committee reviewed evidence published since the previous guidelines were issued in 2004, and addressed similar issues of prevention, risk assessment, monitoring, and treatment.

A notable change from 2004 was the inclusion of a 2009 recommendation update for “universal predischarge bilirubin screening with measures of total serum bilirubin (TSB) or transcutaneous bilirubin (TcB) linked to specific recommendations for follow-up,” the authors wrote.

In terms of prevention, recommendations include a direct antiglobulin test (DAT) for infants whose mother’s antibody screen was positive or unknown. In addition, exclusive breastfeeding is known to be associated with hyperbilirubinemia, but clinicians should support breastfeeding while monitoring for signs of hyperbilirubinemia because of suboptimal feeding, the authors noted. However, the guidelines recommend against oral supplementation with water or dextrose water to prevent hyperbilirubinemia.

For assessment and monitoring, the guidelines advise the use of total serum bilirubin (TSB) as the definitive test for hyperbilirubinemia to guide phototherapy and escalation of care, including exchange transfusion. “The presence of hyperbilirubinemia neurotoxicity risk factors lowers the threshold for treatment with phototherapy and the level at which care should be escalated,” the authors wrote. They also emphasized the need to consider glucose-6-phosphate dehydrogenase deficiency, a genetic condition that decreases protection against oxidative stress and has been identified as a leading cause of hazardous hyperbilirubinemia worldwide.

The guidelines recommend assessing all infants for jaundice at least every 12 hours after delivery until discharge, with TSB or TcB measured as soon as possible for those with suspected jaundice. The complete guidelines include charts for TSB levels to guide escalation of care. “Blood for TSB can be obtained at the time it is collected for newborn screening tests to avoid an additional heel stick,” the authors noted.

The rate of increase in TSB or TcB, if more than one measure is available, may identify infants at higher risk of hyperbilirubinemia, according to the guidelines, and a possible delay of hospital discharge may be needed for infants if appropriate follow-up is not feasible.

In terms of treatment, new evidence that bilirubin neurotoxicity does not occur until concentrations well above those given in the 2004 guidelines justified raising the treatment thresholds, although by a narrow range. “With the increased phototherapy thresholds, appropriately following the current guidelines including bilirubin screening during the birth hospitalization and timely postdischarge follow-up is important,” the authors wrote. The new thresholds, outlined in the complete guidelines, are based on gestational age, hyperbilirubinemia neurotoxicity risk factors, and the age of the infant in hours. However, infants may be treated at lower levels, based on individual circumstances, family preferences, and shared decision-making with clinicians. Home-based phototherapy may be used in some infants, but should not be used if there is a question about the device quality, delivery time, and ability of caregivers to use the device correctly.

“Discontinuing phototherapy is an option when the TSB has decreased by at least 2 mg/dL below the hour-specific threshold at the initiation of phototherapy,” and follow-up should be based on risk of rebound hyperbilirubinemia, according to the guidelines.

“This clinical practice guideline provides indications and approaches for phototherapy and escalation of care and when treatment and monitoring can be safely discontinued,” However, clinicians should understand the rationale for the recommendations and combine them with their clinical judgment, including shared decision-making when appropriate, the authors concluded.
 

Updated evidence supports escalating care

The take-home message for pediatricians is that neonatal hyperbilirubinemia is a very common finding, and complications are rare, but the condition can result in devastating life-long results, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Previous guidelines published in 2004 and updated in 2009 included evidence-based recommendations, but additional research was still needed to provide guidance for providers to prevent complications of hyperbilirubinemia,” said Dr. Haut, who was not involved in producing the guidelines.

“New data documenting additional risk factors, the importance of ongoing breastfeeding support, and addressing hyperbilirubinemia as an urgent problem” are additions to prevention methods in the latest published guidelines, she said.

“Acute encephalopathy and kernicterus can result from hyperbilirubinemia with severe and devastating neurologic effects, but are preventable by early identification and treatment,” said Dr. Haut. Therefore, “it is not surprising that the AAP utilized continuing and more recent evidence to support new recommendations. Both maternal and neonatal risk factors have long been considered in the development of neonatal hyperbilirubinemia, but recent recommendations incorporate additional risk factor evaluation and urgency in time to appropriate care. Detailed thresholds for phototherapy and exchange transfusion will benefit the families of full-term infants without other risk factors and escalate care for those neonates with risk factors.”

However, potential barriers to following the guidelines persist, Dr. Haut noted.

“Frequent infant follow-up can be challenging for busy primary care offices with outpatient laboratory results often taking much longer to obtain than in a hospital setting,” she said.

Also, “taking a newborn to the emergency department or an inpatient laboratory can be frightening for families with the risk of illness exposure. Frequent monitoring of serum bilirubin levels is disturbing for parents and inconvenient immediately postpartum,” Dr. Haut explained. “Few practices utilize transcutaneous bilirubin monitoring which may be one method of added screening.”

In addition, “despite the importance of breastfeeding, ongoing support is not readily available for mothers after hospital discharge. A lactation specialist in the office setting can take the burden off providers and add opportunity for family education.”

As for additional research, “continued evaluation of the comparison of transcutaneous bilirubin monitoring and serum levels along with the use of transcutaneous monitoring in facilities outside the hospital setting may be warranted,” Dr. Haut said. “Data collection on incidence and accompanying risk factors of neonates who develop acute hyperbilirubinemia encephalopathy and kernicterus is a long-term study opportunity.”

The guidelines received no external funding. Lead author Dr. Kemper had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Raising phototherapy thresholds and revising risk assessment are among the key changes in the American Academy of Pediatrics’ updated guidelines for managing hyperbilirubinemia in infants 35 weeks’ gestation and older.

“More than 80% of newborn infants will have some degree of jaundice,” Alex R. Kemper, MD, of Nationwide Children’s Hospital, Columbus, Ohio, and coauthors wrote. Careful monitoring is needed manage high bilirubin concentrations and avoid acute bilirubin encephalopathy (ABE) and kernicterus, a disabling neurologic condition.

The current revision, published in Pediatrics, updates and replaces the 2004 AAP clinical practice guidelines for the management and prevention of hyperbilirubinemia in newborns of at least 35 weeks’ gestation.

The guideline committee reviewed evidence published since the previous guidelines were issued in 2004, and addressed similar issues of prevention, risk assessment, monitoring, and treatment.

A notable change from 2004 was the inclusion of a 2009 recommendation update for “universal predischarge bilirubin screening with measures of total serum bilirubin (TSB) or transcutaneous bilirubin (TcB) linked to specific recommendations for follow-up,” the authors wrote.

In terms of prevention, recommendations include a direct antiglobulin test (DAT) for infants whose mother’s antibody screen was positive or unknown. In addition, exclusive breastfeeding is known to be associated with hyperbilirubinemia, but clinicians should support breastfeeding while monitoring for signs of hyperbilirubinemia because of suboptimal feeding, the authors noted. However, the guidelines recommend against oral supplementation with water or dextrose water to prevent hyperbilirubinemia.

For assessment and monitoring, the guidelines advise the use of total serum bilirubin (TSB) as the definitive test for hyperbilirubinemia to guide phototherapy and escalation of care, including exchange transfusion. “The presence of hyperbilirubinemia neurotoxicity risk factors lowers the threshold for treatment with phototherapy and the level at which care should be escalated,” the authors wrote. They also emphasized the need to consider glucose-6-phosphate dehydrogenase deficiency, a genetic condition that decreases protection against oxidative stress and has been identified as a leading cause of hazardous hyperbilirubinemia worldwide.

The guidelines recommend assessing all infants for jaundice at least every 12 hours after delivery until discharge, with TSB or TcB measured as soon as possible for those with suspected jaundice. The complete guidelines include charts for TSB levels to guide escalation of care. “Blood for TSB can be obtained at the time it is collected for newborn screening tests to avoid an additional heel stick,” the authors noted.

The rate of increase in TSB or TcB, if more than one measure is available, may identify infants at higher risk of hyperbilirubinemia, according to the guidelines, and a possible delay of hospital discharge may be needed for infants if appropriate follow-up is not feasible.

In terms of treatment, new evidence that bilirubin neurotoxicity does not occur until concentrations well above those given in the 2004 guidelines justified raising the treatment thresholds, although by a narrow range. “With the increased phototherapy thresholds, appropriately following the current guidelines including bilirubin screening during the birth hospitalization and timely postdischarge follow-up is important,” the authors wrote. The new thresholds, outlined in the complete guidelines, are based on gestational age, hyperbilirubinemia neurotoxicity risk factors, and the age of the infant in hours. However, infants may be treated at lower levels, based on individual circumstances, family preferences, and shared decision-making with clinicians. Home-based phototherapy may be used in some infants, but should not be used if there is a question about the device quality, delivery time, and ability of caregivers to use the device correctly.

“Discontinuing phototherapy is an option when the TSB has decreased by at least 2 mg/dL below the hour-specific threshold at the initiation of phototherapy,” and follow-up should be based on risk of rebound hyperbilirubinemia, according to the guidelines.

“This clinical practice guideline provides indications and approaches for phototherapy and escalation of care and when treatment and monitoring can be safely discontinued,” However, clinicians should understand the rationale for the recommendations and combine them with their clinical judgment, including shared decision-making when appropriate, the authors concluded.
 

Updated evidence supports escalating care

The take-home message for pediatricians is that neonatal hyperbilirubinemia is a very common finding, and complications are rare, but the condition can result in devastating life-long results, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Previous guidelines published in 2004 and updated in 2009 included evidence-based recommendations, but additional research was still needed to provide guidance for providers to prevent complications of hyperbilirubinemia,” said Dr. Haut, who was not involved in producing the guidelines.

“New data documenting additional risk factors, the importance of ongoing breastfeeding support, and addressing hyperbilirubinemia as an urgent problem” are additions to prevention methods in the latest published guidelines, she said.

“Acute encephalopathy and kernicterus can result from hyperbilirubinemia with severe and devastating neurologic effects, but are preventable by early identification and treatment,” said Dr. Haut. Therefore, “it is not surprising that the AAP utilized continuing and more recent evidence to support new recommendations. Both maternal and neonatal risk factors have long been considered in the development of neonatal hyperbilirubinemia, but recent recommendations incorporate additional risk factor evaluation and urgency in time to appropriate care. Detailed thresholds for phototherapy and exchange transfusion will benefit the families of full-term infants without other risk factors and escalate care for those neonates with risk factors.”

However, potential barriers to following the guidelines persist, Dr. Haut noted.

“Frequent infant follow-up can be challenging for busy primary care offices with outpatient laboratory results often taking much longer to obtain than in a hospital setting,” she said.

Also, “taking a newborn to the emergency department or an inpatient laboratory can be frightening for families with the risk of illness exposure. Frequent monitoring of serum bilirubin levels is disturbing for parents and inconvenient immediately postpartum,” Dr. Haut explained. “Few practices utilize transcutaneous bilirubin monitoring which may be one method of added screening.”

In addition, “despite the importance of breastfeeding, ongoing support is not readily available for mothers after hospital discharge. A lactation specialist in the office setting can take the burden off providers and add opportunity for family education.”

As for additional research, “continued evaluation of the comparison of transcutaneous bilirubin monitoring and serum levels along with the use of transcutaneous monitoring in facilities outside the hospital setting may be warranted,” Dr. Haut said. “Data collection on incidence and accompanying risk factors of neonates who develop acute hyperbilirubinemia encephalopathy and kernicterus is a long-term study opportunity.”

The guidelines received no external funding. Lead author Dr. Kemper had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Infants with bronchopulmonary dysplasia (BPD) who were born to Black mothers were significantly more likely to die or to have a longer hospital stay than infants of other ethnicities, based on data from more than 800 infants.

The overall incidence of BPD is rising, in part because of improved survival for extremely preterm infants, wrote Tamorah R. Lewis, MD, of the University of Missouri, Kansas City, and colleagues.

Previous studies suggest that racial disparities may affect outcomes for preterm infants with a range of neonatal morbidities during neonatal ICU (NICU) hospitalization, including respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis. However, the association of racial disparities with outcomes for preterm infants with BPD remains unclear, they said.

In a study published in JAMA Pediatrics, the researchers, on behalf of the Bronchopulmonary Dysplasia Collaborative, reviewed data from 834 preterm infants enrolled in the BPD Collaborative registry from Jan. 1, 2015, to July 19, 2021, at eight centers in the United States.

The study infants were born at less than 32 weeks’ gestation and were diagnosed with severe BPD according to the 2001 National Institutes of Health Consensus Criteria. The study population included 276 Black infants and 558 white infants. The median gestational age was 24 weeks, and 41% of the infants were female.

The primary outcomes were infant death and length of hospital stay.

Although death was infrequent (4% overall), Black maternal race was significantly associated with an increased risk of death from BPD (adjusted odds ratio, 2.1). Black maternal race also was significantly associated with a longer hospital stay for the infants, with an adjusted between-group difference of 10 days.

Infants of Black mothers also were more likely than those with White mothers to receive invasive respiratory support at the time of delivery. Black infants were more likely than White infants to have lower gestational age, lower birth weight and length, and smaller head circumference.

However, the proportions of cesarean deliveries, gender distribution, and infants small for gestational age were similar between Black and White infant groups. Medication exposure at 36 weeks postmenstrual age (PMA) also was similar for Black and White infants, and 50% of patients overall were treated with nasal continuous positive airway pressure at 36 weeks’ PMA. Awareness of the increased risk of death and longer hospital stay for Black infants is critical, “given the highly variable outcomes for patients with BPD and the uncertainty regarding demographic factors that contribute to late respiratory morbidity in severe BPD,” the researchers wrote.

The study findings were limited by several factors including variations among study centers in the identification and recording of maternal race, lack of data on paternal race, and the focus specifically on Black maternal race and not other ethnicities. Given the documented health disparities for Black individuals in the United States, “we restricted our cohort to only those patients born to Black or White mothers to estimate the association of Black maternal race and adverse in-hospital outcomes in infants with severe BPD,” the researchers wrote

Other limitations include the lack of data surrounding infant death and inability to adjust for all potential modifiers of BPD pathogenesis and progression, such as BPD comorbidities.

Prospective studies are needed to identify the sociodemographic mechanisms that may contribute to health outcome disparities for Black infants with severe BPD, the researchers emphasized.

In the meantime, the results highlight the need for more attention to variations in care for infants with BPD of different races, and approaches to family-centered care should consider “the precise needs of high-risk, structurally disadvantaged families while informing the design of prospective trials that improve outcomes for high-risk subgroups of children with severe BPD,” they concluded.
 

Data raise questions about the origin of disparities

The current study findings contribute to the knowledge and awareness of disparities in the high-risk NICU population, Nicolas A. Bamat, MD, and colleagues wrote in an accompanying editorial. “Further, their findings oppose the central tendency in the literature: that infants of Black mothers have less severe lung disease of prematurity during the birth hospitalization.”

The editorial authors noted that the study’s inclusion of racial characteristics as confounding variables to assess the effect of race on health “can imply questionable assumptions about where in a causal pathway racism begins to exert an effect,” whether after a diagnosis of BPD, during pregnancy in response to inequitable obstetric care, or “centuries ago, propagating forward through the shared experience of communities oppressed by the legacy of racism and its ongoing contemporary manifestations.”

The editorial authors added that, “in lung disease of prematurity, few variables are reliable antecedents to race as an exposure. Complex adjustment is necessary to reduce bias in targeted research questions.” However, the current study findings highlight the need to move toward more equitable neonatal care, and to prioritize interventions to reduce racial health disparities at the level of the NICU as well as at the hospital and government policy levels.
 

Consider range of contributing factors and confounders

The current study is important because “it is imperative to measure racial outcomes in health care in order to highlight and address disparities and biases,” Tim Joos, MD, said in an interview. However, “it can be difficult to determine how much race is a factor in itself versus a proxy for other important characteristics, such as socioeconomic status and level of education, that can confound the results.”

In the current study, the twofold-increased death rate in the premature infants of Black mothers is concerning and deserves further attention, Dr. Joos said. “The 10-day longer length of stay for infants of Black mothers seems quite shocking at first glance, but because of the long hospital stays for these extremely premature infants in general, it is about 7% longer than the infants born to White mothers.”

The take-home message is that this difference is still significant, and can reflect many factors including disease severity and complications, need for feeding assistance, teaching, and setting up home supports, said Dr. Joos.

As for additional research, “it would be useful for hospitals to break down why the differences exist, although I worry a provider or institution will feel they need to discharge Black families sooner to avoid being biased. Family preference and comfort level should be given high priority,” he emphasized.

The study received no outside funding, but lead author Dr. Lewis was supported by the National Institute on Child Health and Development and the Robert Wood Johnson Foundation. Several coauthors were supported by other grants from the National Institutes of Health. Dr. Barnat and one coauthor were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.


 

Infants with bronchopulmonary dysplasia (BPD) who were born to Black mothers were significantly more likely to die or to have a longer hospital stay than infants of other ethnicities, based on data from more than 800 infants.

The overall incidence of BPD is rising, in part because of improved survival for extremely preterm infants, wrote Tamorah R. Lewis, MD, of the University of Missouri, Kansas City, and colleagues.

Previous studies suggest that racial disparities may affect outcomes for preterm infants with a range of neonatal morbidities during neonatal ICU (NICU) hospitalization, including respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis. However, the association of racial disparities with outcomes for preterm infants with BPD remains unclear, they said.

In a study published in JAMA Pediatrics, the researchers, on behalf of the Bronchopulmonary Dysplasia Collaborative, reviewed data from 834 preterm infants enrolled in the BPD Collaborative registry from Jan. 1, 2015, to July 19, 2021, at eight centers in the United States.

The study infants were born at less than 32 weeks’ gestation and were diagnosed with severe BPD according to the 2001 National Institutes of Health Consensus Criteria. The study population included 276 Black infants and 558 white infants. The median gestational age was 24 weeks, and 41% of the infants were female.

The primary outcomes were infant death and length of hospital stay.

Although death was infrequent (4% overall), Black maternal race was significantly associated with an increased risk of death from BPD (adjusted odds ratio, 2.1). Black maternal race also was significantly associated with a longer hospital stay for the infants, with an adjusted between-group difference of 10 days.

Infants of Black mothers also were more likely than those with White mothers to receive invasive respiratory support at the time of delivery. Black infants were more likely than White infants to have lower gestational age, lower birth weight and length, and smaller head circumference.

However, the proportions of cesarean deliveries, gender distribution, and infants small for gestational age were similar between Black and White infant groups. Medication exposure at 36 weeks postmenstrual age (PMA) also was similar for Black and White infants, and 50% of patients overall were treated with nasal continuous positive airway pressure at 36 weeks’ PMA. Awareness of the increased risk of death and longer hospital stay for Black infants is critical, “given the highly variable outcomes for patients with BPD and the uncertainty regarding demographic factors that contribute to late respiratory morbidity in severe BPD,” the researchers wrote.

The study findings were limited by several factors including variations among study centers in the identification and recording of maternal race, lack of data on paternal race, and the focus specifically on Black maternal race and not other ethnicities. Given the documented health disparities for Black individuals in the United States, “we restricted our cohort to only those patients born to Black or White mothers to estimate the association of Black maternal race and adverse in-hospital outcomes in infants with severe BPD,” the researchers wrote

Other limitations include the lack of data surrounding infant death and inability to adjust for all potential modifiers of BPD pathogenesis and progression, such as BPD comorbidities.

Prospective studies are needed to identify the sociodemographic mechanisms that may contribute to health outcome disparities for Black infants with severe BPD, the researchers emphasized.

In the meantime, the results highlight the need for more attention to variations in care for infants with BPD of different races, and approaches to family-centered care should consider “the precise needs of high-risk, structurally disadvantaged families while informing the design of prospective trials that improve outcomes for high-risk subgroups of children with severe BPD,” they concluded.
 

Data raise questions about the origin of disparities

The current study findings contribute to the knowledge and awareness of disparities in the high-risk NICU population, Nicolas A. Bamat, MD, and colleagues wrote in an accompanying editorial. “Further, their findings oppose the central tendency in the literature: that infants of Black mothers have less severe lung disease of prematurity during the birth hospitalization.”

The editorial authors noted that the study’s inclusion of racial characteristics as confounding variables to assess the effect of race on health “can imply questionable assumptions about where in a causal pathway racism begins to exert an effect,” whether after a diagnosis of BPD, during pregnancy in response to inequitable obstetric care, or “centuries ago, propagating forward through the shared experience of communities oppressed by the legacy of racism and its ongoing contemporary manifestations.”

The editorial authors added that, “in lung disease of prematurity, few variables are reliable antecedents to race as an exposure. Complex adjustment is necessary to reduce bias in targeted research questions.” However, the current study findings highlight the need to move toward more equitable neonatal care, and to prioritize interventions to reduce racial health disparities at the level of the NICU as well as at the hospital and government policy levels.
 

Consider range of contributing factors and confounders

The current study is important because “it is imperative to measure racial outcomes in health care in order to highlight and address disparities and biases,” Tim Joos, MD, said in an interview. However, “it can be difficult to determine how much race is a factor in itself versus a proxy for other important characteristics, such as socioeconomic status and level of education, that can confound the results.”

In the current study, the twofold-increased death rate in the premature infants of Black mothers is concerning and deserves further attention, Dr. Joos said. “The 10-day longer length of stay for infants of Black mothers seems quite shocking at first glance, but because of the long hospital stays for these extremely premature infants in general, it is about 7% longer than the infants born to White mothers.”

The take-home message is that this difference is still significant, and can reflect many factors including disease severity and complications, need for feeding assistance, teaching, and setting up home supports, said Dr. Joos.

As for additional research, “it would be useful for hospitals to break down why the differences exist, although I worry a provider or institution will feel they need to discharge Black families sooner to avoid being biased. Family preference and comfort level should be given high priority,” he emphasized.

The study received no outside funding, but lead author Dr. Lewis was supported by the National Institute on Child Health and Development and the Robert Wood Johnson Foundation. Several coauthors were supported by other grants from the National Institutes of Health. Dr. Barnat and one coauthor were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.


 

Infants with bronchopulmonary dysplasia (BPD) who were born to Black mothers were significantly more likely to die or to have a longer hospital stay than infants of other ethnicities, based on data from more than 800 infants.

The overall incidence of BPD is rising, in part because of improved survival for extremely preterm infants, wrote Tamorah R. Lewis, MD, of the University of Missouri, Kansas City, and colleagues.

Previous studies suggest that racial disparities may affect outcomes for preterm infants with a range of neonatal morbidities during neonatal ICU (NICU) hospitalization, including respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis. However, the association of racial disparities with outcomes for preterm infants with BPD remains unclear, they said.

In a study published in JAMA Pediatrics, the researchers, on behalf of the Bronchopulmonary Dysplasia Collaborative, reviewed data from 834 preterm infants enrolled in the BPD Collaborative registry from Jan. 1, 2015, to July 19, 2021, at eight centers in the United States.

The study infants were born at less than 32 weeks’ gestation and were diagnosed with severe BPD according to the 2001 National Institutes of Health Consensus Criteria. The study population included 276 Black infants and 558 white infants. The median gestational age was 24 weeks, and 41% of the infants were female.

The primary outcomes were infant death and length of hospital stay.

Although death was infrequent (4% overall), Black maternal race was significantly associated with an increased risk of death from BPD (adjusted odds ratio, 2.1). Black maternal race also was significantly associated with a longer hospital stay for the infants, with an adjusted between-group difference of 10 days.

Infants of Black mothers also were more likely than those with White mothers to receive invasive respiratory support at the time of delivery. Black infants were more likely than White infants to have lower gestational age, lower birth weight and length, and smaller head circumference.

However, the proportions of cesarean deliveries, gender distribution, and infants small for gestational age were similar between Black and White infant groups. Medication exposure at 36 weeks postmenstrual age (PMA) also was similar for Black and White infants, and 50% of patients overall were treated with nasal continuous positive airway pressure at 36 weeks’ PMA. Awareness of the increased risk of death and longer hospital stay for Black infants is critical, “given the highly variable outcomes for patients with BPD and the uncertainty regarding demographic factors that contribute to late respiratory morbidity in severe BPD,” the researchers wrote.

The study findings were limited by several factors including variations among study centers in the identification and recording of maternal race, lack of data on paternal race, and the focus specifically on Black maternal race and not other ethnicities. Given the documented health disparities for Black individuals in the United States, “we restricted our cohort to only those patients born to Black or White mothers to estimate the association of Black maternal race and adverse in-hospital outcomes in infants with severe BPD,” the researchers wrote

Other limitations include the lack of data surrounding infant death and inability to adjust for all potential modifiers of BPD pathogenesis and progression, such as BPD comorbidities.

Prospective studies are needed to identify the sociodemographic mechanisms that may contribute to health outcome disparities for Black infants with severe BPD, the researchers emphasized.

In the meantime, the results highlight the need for more attention to variations in care for infants with BPD of different races, and approaches to family-centered care should consider “the precise needs of high-risk, structurally disadvantaged families while informing the design of prospective trials that improve outcomes for high-risk subgroups of children with severe BPD,” they concluded.
 

Data raise questions about the origin of disparities

The current study findings contribute to the knowledge and awareness of disparities in the high-risk NICU population, Nicolas A. Bamat, MD, and colleagues wrote in an accompanying editorial. “Further, their findings oppose the central tendency in the literature: that infants of Black mothers have less severe lung disease of prematurity during the birth hospitalization.”

The editorial authors noted that the study’s inclusion of racial characteristics as confounding variables to assess the effect of race on health “can imply questionable assumptions about where in a causal pathway racism begins to exert an effect,” whether after a diagnosis of BPD, during pregnancy in response to inequitable obstetric care, or “centuries ago, propagating forward through the shared experience of communities oppressed by the legacy of racism and its ongoing contemporary manifestations.”

The editorial authors added that, “in lung disease of prematurity, few variables are reliable antecedents to race as an exposure. Complex adjustment is necessary to reduce bias in targeted research questions.” However, the current study findings highlight the need to move toward more equitable neonatal care, and to prioritize interventions to reduce racial health disparities at the level of the NICU as well as at the hospital and government policy levels.
 

Consider range of contributing factors and confounders

The current study is important because “it is imperative to measure racial outcomes in health care in order to highlight and address disparities and biases,” Tim Joos, MD, said in an interview. However, “it can be difficult to determine how much race is a factor in itself versus a proxy for other important characteristics, such as socioeconomic status and level of education, that can confound the results.”

In the current study, the twofold-increased death rate in the premature infants of Black mothers is concerning and deserves further attention, Dr. Joos said. “The 10-day longer length of stay for infants of Black mothers seems quite shocking at first glance, but because of the long hospital stays for these extremely premature infants in general, it is about 7% longer than the infants born to White mothers.”

The take-home message is that this difference is still significant, and can reflect many factors including disease severity and complications, need for feeding assistance, teaching, and setting up home supports, said Dr. Joos.

As for additional research, “it would be useful for hospitals to break down why the differences exist, although I worry a provider or institution will feel they need to discharge Black families sooner to avoid being biased. Family preference and comfort level should be given high priority,” he emphasized.

The study received no outside funding, but lead author Dr. Lewis was supported by the National Institute on Child Health and Development and the Robert Wood Johnson Foundation. Several coauthors were supported by other grants from the National Institutes of Health. Dr. Barnat and one coauthor were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.