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OBJECTIVESLate preterm and term infants comprise 97.3% of annual births in the United States. Admission criteria and the availability of medical interventions in well newborn nurseries are key determinants of these infants remaining within a mother–infant dyad or requiring a NICU admission and resultant separation of the dyad. The objective of this study was to identify national patterns for well newborn nursery care practices.METHODSWe surveyed a physician representative from each nursery in the Better Outcomes through Research for Newborns Network. We described the admission criteria and clinical management of common newborn morbidities and analyzed associations with nursery demographics.RESULTSOf 96 eligible nursery representatives, 69 (72%) completed surveys. Among respondents, 59 (86%) used a minimal birth weight criterion for admission to their well newborn nursery. The most commonly used criteria were 2000 g (n = 29, 49%) and 1800 g (n = 19, 32%), with a range between 1750 and 2500 g. All nurseries used a minimal gestational age criterion for admission; the most commonly used criterion was 35 weeks (n = 55, 80%). Eleven percent of sites required transfer to the NICU for phototherapy. Common interventions in the mother’s room included dextrose gel (n = 56, 81%), intravenous antibiotics (n = 35, 51%), opiates for neonatal abstinence syndrome (n = 15, 22%), and an incubator for thermoregulation (n = 14, 20%).CONCLUSIONSWide variation in admission criteria and medical interventions exists in well newborn nurseries. Further studies may help identify evidence-based optimal admission criteria to maximize care within the mother–infant dyad.

ImportanceThe prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or “Long COVID”) in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults.ObservationsWe describe the protocol for the Pediatric Observational Cohort Study of the NIH’sREsearchingCOVID toEnhanceRecovery (RECOVER) Initiative. RECOVER-Pediatrics is an observational meta-cohort study of caregiver-child pairs (birth through 17 years) and young adults (18 through 25 years), recruited from more than 100 sites across the US. This report focuses on two of five cohorts that comprise RECOVER-Pediatrics: 1) ade novoRECOVER prospective cohort of children and young adults with and without previous or current infection; and 2) an extant cohort derived from the Adolescent Brain Cognitive Development (ABCD) study (n=10,000). Thede novocohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n=6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n=6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n=600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science.Conclusions and RelevanceRECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions.Clinical Trials.gov IdentifierClinical Trial Registration:http://www.clinicaltrials.gov. Unique identifier:NCT05172011

ImportancePregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER- Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads.MethodsRECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through theEunice Kennedy ShriverNational Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators.DiscussionRECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero.RegistrationNCT05172024

BACKGROUND AND OBJECTIVE The Newborn Weight Tool (NEWT) can inform newborn feeding decisions and might reduce health care utilization by preventing excess weight loss. Clinical decision support (CDS) displaying NEWT might facilitate its use. Our study’s objective is to determine the effect of CDS displaying NEWT on feeding and health care utilization. METHODS At an hospital involved in NEWT development, we randomly assigned 2682 healthy infants born ≥36 weeks gestation in 2018–2019 either to CDS displaying NEWT with an electronic flag if most recent weight was ≥75th weight loss centile or to a control of usual care with NEWT accessed at clinician discretion. Our primary outcome was feeding type concordant with weight loss, defined as exclusive breastfeeding for those not flagged, exclusive breastfeeding or supplementation for those flagged once, and supplementation for those flagged more than once. Secondary outcomes included inpatient and outpatient utilization in the first 30 days. We used χ2 and Student’s t tests to compare intervention infants with control and to compare trial infants with those born in 2017. RESULTS Feeding was concordant with for 1854 (74.5%) trial infants and did not differ between randomized groups (P = .65); concordant feeding was higher for all trial infants than for infants born in 2017 (64.4%; P < .0005). Readmission occurred for 51 (3.8%) CDS infants and 45 (3.4%) control infants (P = .56). Among the 60% of trial infants with outpatient records available, there were 3.5 ± 1.7 visits with no differences between randomized groups (P = .10). CONCLUSIONS At an hospital involved in NEWT development, CDS displaying NEWT did not alter either feeding or health care utilization compared with discretionary NEWT access.

Anti-SARS-CoV-2 antibodies have been found in human-milk after COVID-19 infection and vaccination. However, little is known about their persistence in milk after booster vaccination and breakthrough infection. In this study, human-milk, saliva and blood samples were collected from 33 lactating individuals before and after mRNA-based vaccination and COVID-19 breakthrough infections. Antibody levels were measured using ELISA and symptoms were assessed using questionnaires. Evaluation of maternal and infant symptomatology revealed that infected mothers reported more symptoms than vaccinated mothers. We found that after vaccination, human-milk anti-SARS-CoV-2 antibodies persisted for up to 8 months. In addition, distinct patterns of human milk IgA and IgG production we observed after breakthrough infection compared to 3-dose vaccination series alone, indicating a differential central and mucosal immune profiles in hybrid compared with vaccine-induced immunity. To investigate passively-derived milk antibody protection in infants, we examined the persistence of these antibodies in infant saliva after breastfeeding. We found that IgA was more abundant in infant saliva compared to IgG and persist in infant saliva longer after feeding. Our results delineate the differences in milk antibody response to vaccination as compared to breakthrough infection and emphasize the importance of improving the secretion of IgA antibodies to human milk after vaccination to improve the protection of breastfeeding infants.

Background: Pregnant people are vulnerable to new or worsening mental health conditions.This study aims to describe prevalence and course of symptomatic depression and anxiety in pregnancy during the pre-vaccine COVID-19 pandemic. Methods:This is a prospective cohort study of pregnant individuals with known or suspected COVID-19. Participants completed Edinburgh Postnatal Depression Scale (EPDS) and Generalized-Anxiety Disorder-7 (GAD-7) questionnaires at 34weeks gestational age, 6-8weeks postpartum, and 6months postpartum. Prevalence of symptomatic depression and anxiety at each visit was described. Univariable logistic regression analysis was used to determine the association between demographic and clinical factors and symptomatic depression or anxiety Results: 317 participantswere included.The prevalence of antepartum depression was 14.6%, 10.3%, and 20.6% at 34weeks gestational age, 6-8weeks postpartum, and 6months postpartum, respectively. The rate of anxiety was 15.1%, 10.0%, and 17.3% at 34weeks gestational age, 6-8weeks postpartum, and 6months postpartum, respectively. A prior history of depression and/or anxiety (p’sConclusions: Depression and anxiety were prevalent throughout pregnancy and the postpartum period, particularly in those with prior depression and/or anxiety and who quarantined. Strategies that target social isolation may mitigate potential adverse consequences for pregnant people, and continued vigilance in recognition of depression and anxiety in pregnancy should be considered.

In low- and middle-income countries (LMIC), growth impairment is common; however, the trajectory of growth over the course of the first month has not been well characterised. To describe newborn growth trajectory and predictors of growth impairment, we assessed growth frequently over the first 30 days among infants born ≥2000 g in Guinea-Bissau, Nepal, Pakistan and Uganda. In this cohort of 741 infants, the mean birth weight was 3036 ± 424 g. For 721 (98%) infants, weight loss occurred for a median of 2 days (interquartile range, 1-4) following birth until weight nadir was reached 5.9 ± 4.3% below birth weight. At 30 days of age, the mean weight was 3934 ± 592 g. The prevalence of being underweight at 30 days ranged from 5% in Uganda to 31% in Pakistan. Of those underweight at 30 days of age, 56 (59%) had not been low birth weight (LBW), and 48 (50%) had reached weight nadir subsequent to 4 days of age. Male sex (relative risk [RR] 2.73 [1.58, 3.57]), LBW (RR 6.41 [4.67, 8.81]), maternal primiparity (1.74 [1.20, 2.51]) and reaching weight nadir subsequent to 4 days of age (RR 5.03 [3.46, 7.31]) were highly predictive of being underweight at 30 days of age. In this LMIC cohort, country of birth, male sex, LBW and maternal primiparity increased the risk of impaired growth, as did the modifiable factor of delayed initiation of growth. Interventions tailored to infants with modifiable risk factors could reduce the burden of growth impairment in LMIC.

Infant outcomes after maternal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are not well described. In a prospective US registry of 263 infants, maternal SARS-CoV-2 status was not associated with birth weight, difficulty breathing, apnea, or upper or lower respiratory infection through 8 weeks of age.

IntroductionDespite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies.MethodsWe screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale.ResultsWe screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women.Pregnant women with SARS-CoV-2 infection—as compared with uninfected pregnant women—were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12).Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias.ConclusionsThis analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth restriction. As more data become available, we will update these findings per the published protocol.

Objective Adequate infant nutrition is a critical cornerstone of population health, yet adherence to recommended breastfeeding practices is low in many countries in sub-Saharan Africa, including Uganda. This study aims to describe local attitudes, experiences and beliefs related to nutrition in early infancy in Central Uganda Design We conducted 5 focus group discussions and 12 key informant interviews to gather information on local attitudes, experiences and beliefs related to feeding in early infancy. Setting Urban areas of Central Uganda. Participants Parents and healthcare and public health professionals. Results Participants reported numerous concerns related to infant health including inadequate infant weight, premature birth, diarrhea, fever, gastrointestinal infection and malnutrition. Awareness of the infant health benefits of exclusive breastfeeding was prevalent but experienced as in balance with maternal factors that might lead to supplementation, including employment demands, physical appearance, pain, poverty and maternal health and malnutrition. Breastfeeding was highly valued, but use of unsafe breast milk supplements was common, including cow’s milk, black tea, glucose water, fruit juice, millet, maize, rice, potatoes, soy, sorghum, egg yolk, fish and ghee. Expression of breast milk was viewed as not consonant with local culture. Conclusions Participants were aware of the benefits of exclusive breastfeeding but described multiple barriers to achieving it. Supplementation with unsafe breastmilk supplements was considered to be more culturally consonant than milk expression and was reported to be the only affordable potential breast milk substitute for many families.

Pregnancy confers unique immune responses to infection and vaccination across gestation. To date, there is limited data comparing vaccine versus infection-induced nAb to COVID-19 variants in mothers during pregnancy. We analyzed paired maternal and cord plasma samples from 60 pregnant individuals. Thirty women vaccinated with mRNA vaccines were matched with 30 naturally infected women by gestational age of exposure. Neutralization activity against the five SARS-CoV-2 Spike sequences was measured by a SARS-CoV-2 pseudotyped Spike virion assay. Effective nAbs against SARS-CoV-2 were present in maternal and cord plasma after both infection and vaccination. Compared to wild type or Alpha variant Spike, these nAbs were less effective against the Kappa, Delta, and Mu Spike variants. Vaccination during the third trimester induced higher nAb levels at delivery than infection during the third trimester. In contrast, vaccine-induced nAb levels were lower at the time of delivery compared to infection during the first trimester. The transfer ratio (cord nAb level/maternal nAb level) was greatest in mothers vaccinated in the second trimester. SARS-CoV-2 vaccination or infection in pregnancy elicit effective nAbs with differing neutralization kinetics that is impacted by gestational time of exposure. Vaccine induced neutralizing activity was reduced against the Delta, Mu, and Kappa variants.Graphic abstract

Pregnancy confers unique immune responses to infection and vaccination across gestation. To date, there are limited data comparing vaccine- and infection-induced neutralizing Abs (nAbs) against COVID-19 variants in mothers during pregnancy. We analyzed paired maternal and cord plasma samples from 60 pregnant individuals. Thirty women vaccinated with mRNA vaccines (from December 2020 through August 2021) were matched with 30 naturally infected women (from March 2020 through January 2021) by gestational age of exposure. Neutralization activity against the 5 SARS-CoV-2 spike sequences was measured by a SARS-CoV-2-pseudotyped spike virion assay. Effective nAbs against SARS-CoV-2 were present in maternal and cord plasma after both infection and vaccination. Compared with WT spike protein, these nAbs were less effective against the Delta and Mu spike variants. Vaccination during the third trimester induced higher cord-nAb levels at delivery than did infection during the third trimester. In contrast, vaccine-induced nAb levels were lower at the time of delivery compared with infection during the first trimester. The transfer ratio (cord nAb level divided by maternal nAb level) was greatest in mothers vaccinated in the second trimester. SARS-CoV-2 vaccination or infection in pregnancy elicits effective nAbs with differing neutralization kinetics that are influenced by gestational time of exposure.

OBJECTIVES: To describe variations in the practice of hypoglycemia screening and treatment in asymptomatic infants in the United States. METHODS: During the time period from February 2018 to June 2018, we surveyed representatives of hospitals participating in the Better Outcomes through Research for Newborns Network, a national research network of clinicians providing hospital care to term and late-preterm newborns. The survey included 22 questions evaluating practices related to hypoglycemia screening and management of asymptomatic infants. RESULTS: Of 108 network sites, 84 (78%) responded to the survey; 100% had a hypoglycemia protocol for screening at-risk infants in the well-baby nursery. There were wide variations between sites regarding the definition of hypoglycemia (mg/dL) ( CONCLUSIONS: There is a significant practice variation in hypoglycemia screening and management across the United States.

Objective There is a paucity of evidence to guide the clinical care of late preterm and term neonates born to women with perinatal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The objective of this case series is to describe early neonatal outcomes and inpatient management in U.S. hospitals. Study Design We solicited cases of mother–infant dyads affected by novel coronavirus disease 2019 (COVID-19) from the Better Outcomes through Research for Newborns (BORN) Network members. Using a structured case template, participating sites contributed deidentified, retrospective birth hospitalization data for neonates ≥35 weeks of gestation at birth with mothers who tested positive for SARS-CoV-2 before delivery. We describe demographic and clinical characteristics, clinical management, and neonatal outcomes. Results Sixteen U.S. hospitals contributed 70 cases. Birth hospitalizations were uncomplicated for 66 (94%) neonates in which 4 (6%) required admission to a neonatal intensive care unit. None required evaluation or treatment for infection, and all who were tested for SARS-CoV-2 were negative (n = 57). Half of the dyads were colocated (n = 34) and 40% directly breastfed (n = 28). Outpatient follow-up data were available for 13 neonates, all of whom remained asymptomatic. Conclusion In this multisite case series of 70 neonates born to women with SARS-CoV-2 infection, clinical outcomes were overall good, and there were no documented neonatal SARS-CoV-2 infections. Clinical management was largely inconsistent with contemporaneous U.S. COVID-19 guidelines for nursery care, suggesting concerns about the acceptability and feasibility of those recommendations. Longitudinal studies are urgently needed to assess the benefits and harms of current practices to inform evidence-based clinical care and aid shared decision-making. Key Points

Several countries have recently approved the use of mRNA vaccines against COVID-19 under an emergency use authorization. However, no pregnant or lactating individuals were included in the Phase 3 clinical trials of these vaccines despite belonging to a group at high risk for severe complications of COVID-19 infection. We show here that the mRNA from anti-COVID BNT162b2 (Pfizer) and mRNA-1273 (Moderna) vaccines is not detected in human breast milk samples collected 4-48 hours post-vaccine. These results strengthen the recommendation of ABM and WHO that lactating individuals who receive the anti-COVID-19 mRNA-based vaccine should continue to breastfeed their infants uninterrupted.

Breastfeeding is the gold standard for feeding infants because of its long-term benefits to health and development, but most infants in the United States are not exclusively breastfed in the first six months. We enrolled 24 infants who were either exclusively breastfed or supplemented with formula by the age of one month. We collected diet information, stool samples for evaluation of microbiotas by 16S rRNA sequencing, and blood samples for assessment of immune development by flow cytometry from birth to 6 months of age. We further typed the Bifidobacterium strains in stool samples whose 16S rRNA sequencing showed the presence of Bifidobacteriaceae. Supplementation with formula during breastfeeding transiently changed the composition of the gut microbiome, but the impact dissipated by six months of age. For example, Bifidobacterium longum, a bacterial species highly correlated with human milk consumption, was found to be significantly different only at 1 month of age but not at later time points. No immunologic differences were found to be associated with supplementation, including the development of T-cell subsets, B cells, or monocytes. These data suggest that early formula supplementation, given in addition to breast milk, has minimal lasting impact on the gut microbiome or immunity.

Objective Many studies have evaluated birth outcomes with COVID-19, but there has been less attention paid to the risk of early pregnancy loss, despite the known association of miscarriage with viral infection.1 The current literature is limited by small numbers of cases, a focus on inpatients, and lack of longitudinal follow-up.2-5 These studies have primarily been conducted in Europe and Asia which limits generalizability to a diverse US population with unique patient characteristics. To address this evidence gap, we present data on a cohort of U.S. women with SARS-CoV-2 infection in early pregnancy to help inform clinical practice. Study Design PRIORITY is an ongoing nationwide prospective cohort study of COVID-19 during pregnancy in the U.S. Participants are ≥ 13 years, under investigation for or had confirmed COVID-19 defined as positive PCR for SARS-CoV-2, enrolled from March-October 2020. For this analysis, we selected participants who enrolled at Results Among the 1,338 PRIORITY participants, 109 comprise the analysis set who enrolled at In the COVID-19 positive group, 6/94 (6.4%, 95% CI 2.4%-13.4%) had EPL compared with 1/15 in the COVID-19 negative group (6.7%, 95% CI 0.1%-31.9%). In the COVID-19 positive group, 5 EPLs occurred at 7-12 weeks and one at 15 weeks. In a subgroup analysis of 34 COVID-19 positive participants enrolled at 24 weeks. Conclusion In this nationwide study of pregnant people in the U.S., the risk of pregnancy loss at

BACKGROUND AND OBJECTIVES: Guidelines encourage exclusive breastfeeding for healthy newborns but lack specificity regarding criteria for medically indicated supplementation, including type, timing, and best practices. We set out to describe practice patterns and provider perspectives regarding medically indicated supplementation of breastfeeding newborns across the United States. METHODS: From 2017 to 2018, we surveyed the Better Outcomes through Research for Newborns representative from each Better Outcomes through Research for Newborns hospital regarding practices related to medically indicated supplementation. We used descriptive statistics to compare practices between subgroups defined by breastfeeding prevalence and used qualitative methods and an inductive approach to describe provider opinions. RESULTS: Of 96 providers representing discrete hospitals eligible for the study, 71 participated (74% response rate). Practices related to criteria for supplementation and pumping and to type and caloric density of supplements varied widely between hospitals, especially for late preterm infants, whereas practices related to lactation consultant availability and hand expression education were more consistent. The most commonly reported criterion for initiating supplementation was weight loss of ≥10% from birth weight, and bottle-feeding was the most commonly reported method; however, practices varied widely. Donor milk use was reported at 20 (44%) hospitals with ≥81% breastfeeding initiation and 1 (4%) hospital with CONCLUSIONS: Strategies related to supplementation vary among US hospitals. Donor milk availability is concentrated in hospitals with the highest prevalence of breastfeeding. Implementation of evidence-based management of supplementation among US hospitals has the potential to improve the care of term and late preterm newborns.

Electronic health record (EHR) systems can be configured to deliver novel EHR interventions that influence clinical decision making and to support efficient randomized controlled trials (RCTs) designed to evaluate the effectiveness, safety, and costs of those interventions. In designing RCTs of EHR interventions, one should carefully consider the unit of randomization (for example, patient, encounter, clinician, or clinical unit), balancing concerns about contamination of an intervention across randomization units within clusters (for example, patients within clinical units) against the superior control of measured and unmeasured confounders that comes with randomizing a larger number of units. One should also consider whether the key computational assessment components of the EHR intervention, such as a predictive algorithm used to target a subgroup for decision support, should occur before randomization (so that only 1 subgroup is randomized) or after randomization (including all subgroups). When these components are applied after randomization, one must consider expected heterogeneity in the effect of the differential decision support across subgroups, which has implications for overall impact potential, analytic approach, and sample size planning. Trials of EHR interventions should be reviewed by an institutional review board, but may not require patient-level informed consent when the interventions being tested can be considered minimal risk or quality improvement, and when clinical decision making is supported, rather than controlled, by an EHR intervention. Data and safety monitoring for RCTs of EHR interventions should be conducted to guide institutional pragmatic decision making about implementation and ensure that continuing randomization remains justified. Reporting should follow the CONSORT (Consolidated Standards of Reporting Trials) Statement, with extensions for pragmatic trials and cluster RCTs when applicable, and should include detailed materials to enhance reproducibility.

BACKGROUND: Cutaneous lumbosacral findings in neonates are common in the newborn nursery but may also be associated with occult spinal dysraphism. Variation in management of lumbosacral findings by neonatal clinicians has not been previously described. METHODS: Clinicians in the Better Outcomes through Research for Newborns (BORN) Network were invited to participate in an electronic survey. Participants reviewed 18 photographs of lumbosacral findings in asymptomatic neonates and selected 1 or more initial management step(s): routine care, watchful waiting, imaging, and/or subspecialty consultation. Additional data collected include ease of access to imaging and subspecialty consultants and characteristics of respondents. RESULTS: Of 407 BORN Network clinicians, 206 (51%) completed the survey. Respondents were in >90% agreement in initial management approach of 8 of 18 cases. The most common initial actions were spinal ultrasound (53%), neurosurgery evaluation (18%), and MRI (13%). Anomalies of the gluteal crease had the lowest proportion of agreement. In 2 cases, there were differences in respondents’ choice to image or consult a subspecialist depending on their percent clinical full time equivalent spent taking care of neonates CONCLUSIONS: Variation in initial management of neonatal lumbosacral findings by clinicians in the BORN Network was seen most often for deviations of the gluteal crease, flat vascular macules, and coccygeal hair.

Messenger RNA (mRNA) vaccines against COVID-19 were recently approved under an emergency use authorization.1 However, there is a paucity of data regarding vaccine safety in pregnant or lactating individuals who were excluded from phase 3 clinical trials,2,3 and many mothers have declined vaccination or decided to discontinue breastfeeding (temporarily or permanently) due to concern that maternal vaccination may alter human milk. The World Health Organization recommends that breastfeeding individuals be vaccinated and does not advise cessation of breastfeeding following vaccine administration.4,5 The Academy of Breastfeeding Medicine states that there is little plausible risk that vaccine nanoparticles or mRNA would enter breast tissue or be transferred to milk,6 which could theoretically result in priming of infant immune responses that could alter childhood immunity. However, there are no direct data. To address this knowledge gap, we analyzed milk samples to determine if vaccine-related mRNA was detectable in human milk after vaccination.

Background: Many breastfed infants receive supplemental feeds during the birth hospitalization, either by maternal request or due to medical indications. Donor milk from a certified milk bank has become increasingly available and is now used in some settings for term and late preterm infants. No studies have explored maternal opinions about donor milk and formula as options for supplementary feedings. Research aim: This study aimed to explore maternal perceptions about donor milk and formula supplementation and implications for continued breastfeeding. Methods: The authors conducted semistructured interviews with 30 postpartum mothers of healthy newborns who breastfed and gave supplementary feedings with pasteurized donor milk and/or formula during the birth hospitalization. They analyzed transcripts using the constant comparative method and identified four major themes. Results: Identified themes included the following: (a) Donor milk is seen as temporary whereas formula is seen as an ongoing plan, (b) formula is viewed as familiar whereas donor milk is viewed as unfamiliar, (c) donor milk is costly and challenging logistically, and (d) donor milk is “healthier.” Conclusion: For mothers who view donor milk as temporary and formula as permanent, the provision of donor milk rather than formula when supplementation is medically indicated may have the potential to promote the return to exclusive maternal breastfeeding. Barriers to the use of donor milk include cost and lack of familiarity and access.

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols free from commercial interest or influence for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient.

OBJECTIVE To determine whether higher reimbursement for children's preventive dentistry correlates with greater utilization of preventive dental care. METHODS A cross-sectional analysis of National Survey of Children's Health 2011/2012 was conducted, combined with state Medicaid reimbursement rates for preventive dentistry. Analyses included prevalence, unadjusted odds ratios, and multivariable logistic regression for receipt of preventive dental services. RESULTS Of all surveyed American children 1-17 years, almost 20 percent had not received preventive dental care in prior year; this percentage is even higher in those with public insurance. Each $10 increase in state reimbursement was associated with a 17 percent decrease in odds of children not receiving preventive services. CONCLUSIONS Higher state reimbursement for preventive services may increase children's receipt of preventive dental care.

Objective: Early exposure to formula can interfere with successful long-term breastfeeding. The objective of this study was to determine whether limiting the volume of formula used in the first month attenuates formula's detrimental impact on long-term breastfeeding success. Materials and Methods: Using detailed data on dietary intake from a randomized clinical trial, we conducted a secondary analysis of the association between volume of formula received in the first month and breastfeeding cessation before 6 and 12 months of age. We used descriptive statistics and multivariable logistic regression, respectively, to explore this association without and with adjustment for demographic and clinical predictors of infant feeding. Results: Among 199 breastfeeding infants, 80 (40%) received formula daily at 1 month of age, and breastfeeding cessation before 6 and 12 months of age was higher for these infants (46% and 67%) than for those breastfed exclusively (6% and 27%) (p

Importance Breastfeeding through 6 and 12 months are 2 goals of the Centers for Disease Control and Prevention Healthy People 2020 initiative, but the 6-month goal is met for only 52% of US infants and the 12-month goal for 30% of US infants. Objective To determine whether structured, short-term formula supplementation for at-risk neonates affects the proportion still breastfeeding at 6 and 12 months. Design, Setting, and Participants This randomized clinical trial conducted at 2 US academic medical centers enrolled 164 exclusively breastfeeding mother-infant dyads of mothers who were not yet producing copious milk and infants who were 24 to 72 hours old with newborn weight loss at or above the 75th percentile for age. Participants were enrolled from January 2015 through September 2016. Interventions Early Limited Formula (ELF), a structured formula supplementation protocol (10 mL formula fed after each breastfeeding until mothers produced copious milk), compared with control dyads, who continued exclusive breastfeeding and received a safety teaching intervention. Main Outcomes and Measures The study’s primary outcome was any breastfeeding at 6 months. Secondary outcomes included age at breastfeeding cessation and any breastfeeding at 12 months. All outcomes were assessed by maternal phone survey. Results Eighty-two newborns were randomized to ELF and 82 to the control group. Mean (SD) maternal age was 31.4 (5.9) years, and 114 (69.5%) self-identified as non-Hispanic white; 20 (12.2%), Hispanic; 17 (10.4%), Asian; 5 (3.0%), non-Hispanic black; and 7 (4.3%), other. Compared with controls, mothers randomized to ELF were less likely to be married (n = 53 [64.6%] vs n = 66 [80.5%];P = .03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months;P = .049). Median (interquartile range) duration of breastfeeding in the cohort was 9 (6-12) months. At 6 months, 47 (65%) infants randomized to ELF were breastfeeding, compared with 60 (77%) of the control infants (absolute difference, –12%; 95% CI, –26% to 3%;P = .12). At 12 months, 21 of the 71 ELF infants available for analysis (29.6%) were breastfeeding, compared with 37 of the available 77 (48.1%) control infants (risk difference, –18%; 95% CI, –34% to –3%). Marital status and intended breastfeeding duration were both associated with breastfeeding duration; models adjusting for these found a hazard ratio for time-to-event of breastfeeding cessation through 12 months of 0.74 (95% CI, 0.48-1.14) for ELF infants compared with infants in the control group. Conclusions and Relevance In this cohort with high breastfeeding prevalence, ELF was not associated with any improvement in breastfeeding duration. Future research should examine the effect of ELF in populations at higher risk of early cessation. Trial Registration ClinicalTrials.gov identifier:NCT02313181

Background. Pasteurized donor human milk (DHM) use for healthy newborns is increasing; however, no studies have explored its effect on breastfeeding outcomes. Patients and Methods. We enrolled 60 healthy, term breastfeeding newborns with ≥4.5% weight loss in the first 36 hours in a randomized controlled trial. Thirty newborns were randomly assigned to early limited-volume DHM supplementation and 30 newborns to exclusive breastfeeding. Mothers were surveyed at 1 week and 1, 2, and 3 months regarding the mode of infant feeding. Comparing infants randomized to DHM supplementation with those exclusively breastfeeding, there was no significant difference in the proportion using formula at 1 week (21% vs 7%, P = .15), nor in the proportion of any breastfeeding (79% vs 90%, P = .30) or breastfeeding without formula at 3 months (62% vs 77%, P = .27). Conclusion For newborns with ≥4.5% weight loss in the first 36 hours, early limited-volume supplementation with DHM is unlikely to have a significant favorable impact on breastfeeding outcomes.

OBJECTIVES: Globally, more than 200 million children under 5 experience wasting and stunting. Wasting and stunting often begin during early infancy and have detrimental impacts on childhood health. Understanding local perspectives on feeding during early infancy might allow the design of interventions to improve early infant growth. The purpose of this study was to identify attitudes and experiences related to feeding during the first month after birth in Guinea-Bissau. METHODS: We employed a mixed-methods approach to data collection, using focus groups and individual interviews. We completed five focus groups with mothers, fathers, community health workers and nurses, and six individual interviews with hospital administrators and policy makers. Portuguese and Mandinka, common languages in Guinea-Bissau, were used for data collection. All focus groups and interviews were recorded, translated and transcribed in English for analyses. Thematic analyses were used to examine variations in the participants’ perspectives on a priori themes and to discern emerging themes. RESULTS: A priori themes were (1) perspectives on breastfeeding, (2) issues related to infant health, (3) local practices of early supplementation, and (4) opinions about a nutritional intervention for infants. Emerging themes included (a) maternal health and (b) maternal supplementation. Participants reported a wide variety of feeding practices in early infancy, including exclusive breastfeeding, supplementation with baby formula and supplementation with other foods including fruit, grain, nuts, milk and herbs. Poverty, inadequate knowledge on breastfeeding and childhood health, and poor access to health care were identified as potential challenges for successfully implementing an intervention to improve growth during early infancy. Also, participants described that maternal health is fundamental to infant health and advocated for interventions supplementing mothers’ nutrition. CONCLUSIONS: A wide range of feeding practices are common during the newborn period in Guinea-Bissau. While early interventions to improve infant growth may be acceptable and feasible, developing effective strategies must include components addressing the stakeholders’ concerns related to poverty, inadequate knowledge and poor access to health care. FUNDING SOURCES: Melinda and Bill Gates Foundation.

OBJECTIVES: To describe initial newborn weight loss and its association with subsequent growth among at-risk newborn populations in Uganda. METHODS: We weighed 205 breastfeeding infants born at ≥2000 g in Kampala and Mukono, Uganda, to ± 5 g at −2 (P = 0.005). In this cohort, 8 (90%) of LBW infants were born to primiparous mothers, compared to 59 (30%) non-LBW infants (P = 0.002). Infants of primiparous mothers were also more likely to have low WAZ at 30 days of age (70% vs. 31%; P = 0.02). CONCLUSIONS: In this cohort of breastfed infants from Kampala and Mukono, Uganda, breastfeeding newborns lost about 6% of their birth weight at nadir, which occurred at an average of 1.7 days of age. Infants born to primiparous mothers appeared to be at greater risk of underweight at 30 days of age. Understanding the relationship between early weight loss and subsequent outcomes could inform the development of strategies to optimize growth. FUNDING SOURCES: The Bill and Melinda Gates Foundation.

ObjectiveAlthough initiating breast-feeding is common in Indonesia, rates of exclusive breast-feeding are low. Our objective was to identify early barriers to exclusive breast-feeding in Indonesian hospitals.DesignQualitative. Semi-structured interviews were conducted in April–June 2015. The data were analysed using thematic analysis.SettingIndonesian provinces of Jakarta, Banten and West Java.SubjectsFifty-four participants including public health officials, hospital administrators, health-care professionals and parents.ResultsFive themes were identified as contributing to low rates of early exclusive breast-feeding in Indonesian hospitals: (i) quality and quantity of breast-feeding education; (ii) marketing and influence of infant formula manufacturers; (iii) hospital infrastructure; (iv) policy, legislation and protocols; and (v) perceived need for infant formula supplementation. Participants noted that providers and mothers receive inadequate or incorrect education regarding breast-feeding; manufacturers promote infant formula use both inside and outside hospitals; constraints in physical space and hospital design interfere with early breast-feeding; legislation and protocols designed to promote breast-feeding are inconsistently enforced and implemented; and providers and mothers often believe infant formula is necessary to promote infant health. All participants identified numerous barriers to early exclusive breast-feeding that related to more than one identified theme.ConclusionsOur study identified important barriers to early exclusive breast-feeding in Indonesian hospitals, finding that participants consistently reported multifaceted barriers to early exclusive breast-feeding. Future research should examine whether system-level interventions such the Baby-Friendly Hospital Initiative might improve rates of exclusive breast-feeding by improving breast-feeding education, reducing manufacturer influence, modifying existing infrastructure and providing tools needed for protocols and counselling.

Milk supply concern is the most common reason for breastfeeding discontinuation and maternal anxiety is also associated with reduced breastfeeding duration. Newborn excess weight loss (EWL) could trigger milk supply concern and anxiety and might be amenable to modification. Our objective was to determine the relationship between EWL and the development of milk supply concern and anxiety and the effect of such development on breastfeeding duration. We conducted a cohort analysis using data previously obtained from a randomised controlled trial comparing two post-hospital discharge follow-up strategies. For 1107 well, singleton infants born at ≥34 weeks, we extracted data on all inpatient infant weights. EWL was defined as the loss of ≥10% of birthweight. We surveyed mothers to obtain data on state anxiety and milk supply concern at birth and at 2 weeks. Our final outcome was breastfeeding at 6 months. Seventy (6.3%) infants developed EWL during the birth hospitalisation. At 2 weeks, milk supply concern and positive anxiety screen were more common (42% and 18%, respectively) among mothers whose infants had had EWL than among mothers whose infants had not had EWL (20% and 6%, respectively) (P

BACKGROUND: The majority of newborns are exclusively breastfed during the birth hospitalization, and weight loss is nearly universal for these neonates. The amount of weight lost varies substantially among newborns with higher amounts of weight loss increasing risk for morbidity. No hour-by-hour newborn weight loss nomogram exists to assist in early identification of those on a trajectory for adverse outcomes. METHODS: For 161 471 term, singleton neonates born at ≥36 weeks’ gestation at Northern California Kaiser Permanente hospitals in 2009–2013, data were extracted from the birth hospitalization regarding delivery mode, race/ethnicity, feeding type, and weights from electronic records. Quantile regression was used to create nomograms stratified by delivery mode that estimated percentiles of weight loss as a function of time among exclusively breastfed neonates. Weights measured subsequent to any nonbreastmilk feeding were excluded. RESULTS: Among this sample, 108 907 newborns had weights recorded while exclusively breastfeeding with 83 433 delivered vaginally and 25 474 delivered by cesarean. Differential weight loss by delivery mode was evident 6 hours after delivery and persisted over time. Almost 5% of vaginally delivered newborns and >10% of those delivered by cesarean had lost ≥10% of their birth weight 48 hours after delivery. By 72 hours, >25% of newborns delivered by cesarean had lost ≥10% of their birth weight. CONCLUSIONS: These newborn weight loss nomograms demonstrate percentiles for weight loss by delivery mode for those who are exclusively breastfed. The nomograms can be used for early identification of neonates on a trajectory for greater weight loss and related morbidities.

We read with interest the quality report by Feldman-Winter et al1 in which they described their efforts to increase breastfeeding initiation and exclusive breastfeeding rates by helping hospitals achieve Baby-Friendly Hospital Initiative (BFHI) designation. Not only did they track and improve BFHI, they also tracked and improved rates of overall and exclusive breastfeeding. We applaud … E-mail: matthew.garber{at}jax.ufl.edu

Maternal postpartum depression (PPD) has an impact on mothers and infants. The American Academy of Pediatrics recommends screening for PPD at well-child visits during the first 6 months. We conducted a secondary data analysis of depression screening data collected each month during months 1 to 12 postpartum for 152 mothers with an infant participating in a randomized controlled trial. We used descriptive statistics to describe the incidence and the cumulative incidence of a positive PPD screen during months 1 to 12 postpartum. The results indicate that the initial positive screen for PPD can occur any time during the first 12 months postpartum and 15% had their first positive screen between months 6 and 12. Additionally, positive PPD screens are consistently high throughout the first year postpartum with the highest rate of positive screens at 12 months postpartum (23%). Our data suggest that PPD screening through 12 months may be most beneficial for families.

Objective To determine whether using 10 mL formula after each breastfeeding before copious maternal milk production affects breastfeeding duration, readmission, and intestinal microbiota through 1 month of age. Study design In this randomized controlled trial, we enrolled 164 exclusively breastfeeding newborns, 24-72 hours old, whose weight loss was ≥75th percentile for age, and whose mothers had not yet begun mature milk production. Enrolled newborns were assigned randomly to either supplement breastfeeding with early limited formula (ELF), 10 mL of formula after each breastfeeding stopped at the onset of copious maternal milk production (intervention), or to continue exclusive breastfeeding (control). Outcomes assessed through 1 month included breastfeeding duration, readmission, and intestinal microbiota. Results At 1 week of age, 95.8% of infants receiving ELF and 93.5% of control infants were still breastfeeding (P > .5); readmission occurred for 4 (4.8%) control infants and none of the infants receiving ELF (P = .06). At 1 month of age, 86.5% of infants receiving ELF and 89.7% of control infants were still breastfeeding (P > .5); 54.6% of infants receiving ELF and 65.8% of controls were breastfeeding without formula (P = .18). ELF did not lead to decreased abundance of Lactobacillus or Bifidobacterium and was not associated with expansion of Clostridium. Conclusion In this population of healthy newborns with weight loss ≥75th percentile, ELF did not interfere with breastfeeding at 1 month, breastfeeding without formula at 1 month, or intestinal microbiota. ELF may be an important therapeutic option for newborns with the potential to reduce readmission rates. Trial Registration Clinicaltrials.gov : NCT02313181.

BACKGROUND AND OBJECTIVES: The extent to which clinicians use currently available guidelines for early-onset sepsis (EOS) screening has not been described. The Better Outcomes through Research for Newborns network represents 97 nurseries in 34 states across the United States. The objective of this study was to describe EOS risk management strategies across a national sample of newborn nurseries. METHODS: A Web-based survey was sent to each Better Outcomes through Research for Newborns network nursery site representative. Nineteen questions addressed specific practices for assessing and managing well-appearing term newborns identified at risk for EOS. RESULTS: Responses were received from 81 (83%) of 97 nurseries located in 33 states. Obstetric diagnosis of chorioamnionitis was the most common factor used to identify risk for EOS (79 of 81). Among well-appearing term infants with concern for maternal chorioamnionitis, 51 of 79 sites used American Academy of Pediatrics or Centers for Disease Control and Prevention guidelines to inform clinical care; 11 used a published sepsis risk calculator; and 2 used clinical observation alone. Complete blood cell count (94.8%) and C-reactive protein (36.4%) were the most common laboratory tests obtained and influenced duration of empirical antibiotics at 13% of the sites. Some degree of mother–infant separation was required for EOS evaluation at 95% of centers, and separation for the entire duration of antibiotic therapy was required in 40% of the sites. CONCLUSIONS: Substantial variation exists in newborn EOS risk assessment, affecting the definition of risk, the level of medical intervention, and ultimately mother–infant separation. Identification of the optimal approach to EOS risk assessment and standardized implementation of such an approach could affect care of a large proportion of newborns.