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Neonatal hyperbilirubinemia is one of the leading causes of neonatal readmission-especially severe hyperbilirubinemia and its complications-and it influences disease burden as well as neonatal and maternal health. Smartphones have been shown to have satisfactory accuracy in screening neonatal bilirubin levels, but the impact of this technology on neonatal health care service and maternal health outcomes is still unknown. The aim of this study was to evaluate the impact of a smartphone-based out-of-hospital neonatal jaundice screening program on neonatal readmission rates for jaundice and related maternal anxiety. This was a 2-arm, unblinded, randomized controlled trial with 30 days of intervention and follow-up periods. From August 2019 to August 2020, healthy mother-infant dyads were recruited on-site from 3 public hospitals in Hainan, China. Intervention group mothers used the smartphone app to routinely monitor neonatal jaundice at home under the web-based guidance of pediatricians. Control group participants received routine care. The primary study outcome was the neonatal readmission rate due to jaundice within 30 days of the first hospital discharge. The secondary outcome was the maternal anxiety score associated with neonatal jaundice. The data were collected through a self-assessed questionnaire. All participants were included in the analysis (intention-to-treat). In this study, 1424 mother-infant dyads were recruited, comprising 1424 mothers and 1424 newborns. The median age of the mothers was 29 (IQR 26-32) years, and there were 714 (50.1%) male neonates. These mother-infant dyads were randomly assigned to the intervention group and the control group, with 712 dyads in each group; only 1187 of these dyads completed the follow-up. We found that the adjusted 30-day neonatal readmission rate due to jaundice reduced by 10.5% (71/605, 11.7% vs 141/582, 24.2%; 95% CI 5%-15.9%; odds ratio 0.4, 95% CI 0.3-0.5; P<.001) and the relevant maternal anxiety mean score decreased by 3.6 (95% CI -4.4 to -2.8; β=-3.6, 95% CI -4.5 to -2.8; P<.001) in the intervention group compared to those in the routine care group. Our study shows that the smartphone-based out-of-hospital screening method for neonatal hyperbilirubinemia decreased the neonatal readmission rate within 30 days from the first discharge and improved maternal mental health to some degree, thus demonstrating the usefulness of this screening app for follow-up in pediatric care. China Clinical Trial Registration Center, ChiCTR2100049567; http://www.chictr.org.cn/showproj.aspx?proj=64245.

\"Juniper French was born four months early, at 23 weeks gestation. She weighed 1 pound, 4 ounces, and her twiggy body was the length of a Barbie doll. Her head was smaller than a tennis ball, her skin was nearly translucent, and through her chest you could see her flickering heart. Babies like Juniper, born at the edge of viability, trigger the question: Which is the greater act of love--to save her, or to let her go? Kelley and Thomas French chose to fight for Juniper's life, and this is their incredible tale. In one exquisite memoir, the authors explore the border between what is possible and what is right. They marvel at the science that conceived and sustained their daughter and the love that made the difference. They probe the bond between a mother and a baby, between a husband and a wife. They trace the journey of their family from its fragile beginning to the miraculous survival of their now thriving daughter.\" -- Dust jacket.

Purpose Newborn genomic sequencing (nGS) has great potential to improve pediatric care. Parental interest and concerns about genomics are relatively unexplored. Understanding why parents decline research consent for nGS may reveal implementation barriers. Methods We evaluated parental interest in a randomized trial of nGS in well-baby and intensive care unit nursery settings. Interested families attended an informational enrollment session (ES) with a genetic counselor prior to consenting. Reason(s) for declining participation and sociodemographic associations were analyzed. Results Of 3860 eligible approached families, 10% attended ES, 67% of whom enrolled. Of 1760 families queried for decline reasons, 58% were uninterested in research. Among 499 families considering research, principal reasons for decline prior to ES included burdensome study logistics (48%), feeling overwhelmed postpartum (17%), and lack of interest/discomfort with genetic testing (17%). Decliners after ES more often cited concerns about privacy/insurability (41%) and uncertain/unfavorable results (23%). Conclusion Low interest in research and study logistics were major initial barriers to postpartum enrollment and are likely generic to many postpartum research efforts. Concerns over privacy and result implications were most commonly cited in decliners after ES. Understanding parental concerns around research nGS may inform future integration of nGS into newborn screening, predictive testing, and pediatric diagnostics.

Neonatal intensive care has been one of the most morally controversial areas of medicine during the past thirty years. This study examines the interconnected development of four key aspects of neonatal intensive care: medical advances, ethical analysis, legal scrutiny, and econometric evaluation. The authors assert that a dramatic shift in societal attitudes toward newborns and their medical care was a stimulus for and then a result of developments in the medical care of newborns. They divide their analysis into three eras of neonatal intensive care. The first, characterized by the rapid advance of medical technology from the late 1960s to the Baby Doe case of 1982, established neonatal care as a legitimate specialty of medical care, separate from the rest of pediatrics and medicine. During this era, legal scholars and moral philosophers debated the relative importance of parental autonomy, clinical prognosis, and children's rights. The second era, beginning with the Baby Doe case (a legal battle that spurred legislation mandating that infants with debilitating birth defects be treated unless the attending physician deems efforts to prolong life \"futile\"), stimulated efforts to establish a consistent federal standard on neonatal care decisions and raised important moral questions concerning the meaning of \"futility\" and of \"inhumane\" treatment. In the third era, a consistent set of decision-making criteria and policies was established. These policies were the result of the synergy and harmonization of newly agreed upon ethical principles and newly discovered epidemiological characteristics of neonatal care. Tracing the field's recent history, notable advances, and considerable challenges yet to be faced, the authors present neonatal bioethics as a paradigm of complex conversation among physicians, philosophers, policy makers, judges, and legislators which has led to responsible societal oversight of a controversial medical innovation.

IntroductionJaundice caused by hyperbilirubinaemia is a physiological phenomenon in the neonatal period. However, severe hyperbilirubinaemia, when left untreated, may cause kernicterus, a severe condition resulting in lifelong neurological disabilities. Although commonly applied, visual inspection is ineffective in identifying severe hyperbilirubinaemia. We aim to investigate whether among babies cared for in primary care: (1) transcutaneous bilirubin (TcB) screening can help reduce severe hyperbilirubinaemia and (2) primary care-based (versus hospital-based) phototherapy can help reduce hospital admissions.Methods and analysisA factorial stepped-wedge cluster randomised controlled trial will be conducted in seven Dutch primary care birth centres (PCBC). Neonates born after 35 weeks of gestation and cared for at a participating PCBC for at least 2 days within the first week of life are eligible, provided they have not received phototherapy before. According to the stepped-wedge design, following a phase of ‘usual care’ (visual assessment and selective total serum bilirubin (TSB) quantification), either daily TcB measurement or, if indicated, phototherapy in the PCBC will be implemented (phase II). In phase III, both interventions will be evaluated in each PCBC. We aim to include 5500 neonates over 3 years.Primary outcomes are assessed at 14 days of life: (1) the proportion of neonates having experienced severe hyperbilirubinaemia (for the TcB screening intervention), defined as a TSB above the mean of the phototherapy and the exchange transfusion threshold and (2) the proportion of neonates having required hospital admission for hyperbilirubinaemia treatment (for the phototherapy intervention in primary care).Ethics and disseminationThis study has been approved by the Medical Research Ethics Committee of the Erasmus MC Rotterdam, the Netherlands (MEC-2017-473). Written parental informed consent will be obtained. Results from this study will be published in peer-reviewed journals and presented at (inter)national meetings.Trial registration numberNTR7187.

Background The greatest opportunity for lifelong impact of genomic sequencing is during the newborn period. The “BabySeq Project” is a randomized trial that explores the medical, behavioral, and economic impacts of integrating genomic sequencing into the care of healthy and sick newborns. Methods Families of newborns are enrolled from Boston Children’s Hospital and Brigham and Women’s Hospital nurseries, and half are randomized to receive genomic sequencing and a report that includes monogenic disease variants, recessive carrier variants for childhood onset or actionable disorders, and pharmacogenomic variants. All families participate in a disclosure session, which includes the return of results for those in the sequencing arm. Outcomes are collected through review of medical records and surveys of parents and health care providers and include the rationale for choice of genes and variants to report; what genomic data adds to the medical management of sick and healthy babies; and the medical, behavioral, and economic impacts of integrating genomic sequencing into the care of healthy and sick newborns. Discussion The BabySeq Project will provide empirical data about the risks, benefits and costs of newborn genomic sequencing and will inform policy decisions related to universal genomic screening of newborns. Trial registration The study is registered in ClinicalTrials.gov Identifier: NCT02422511 . Registration date: 10 April 2015.

The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death. In this multicountry, placebo-controlled, randomized trial, we assigned women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery to receive a single 2-g oral dose of azithromycin or placebo. The two primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis. During an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit. A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P<0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events. Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; A-PLUS ClinicalTrials.gov number, NCT03871491.).

Neonatal hyperbilirubinaemia is more common in Asian-descendent populations, but differences in disease severity are poorly reported. Our study aimed to compare neonatal hyperbilirubinaemia severity between European and Indian subcontinent descendent newborns. We conducted a single-centre retrospective cohort study including newborns admitted with unconjugated hyperbilirubinaemia (January 2016 to December 2021). Patients were followed during admission, comparing those with European ancestry (control group) and Indian subcontinent ancestry (India, Pakistan, Bangladesh and Nepal) (study group). The primary outcome was severe hyperbilirubinemia (TSB > 25 mg/dL, phototherapy > 6 h or need for exchange transfusion [ET]), and the secondary was TSB levels. Adjusted analysis for potential confounding factors was performed using binary logistic regression models. Of 110 newborns included, 27 (24.5%) had Indian subcontinent ancestry. Occurrence of TSB > 25 mg/dL was significantly higher in the study group (22.2% vs. 4.8%, p  = 0.006), while no differences were noted in exposure to phototherapy > 6 h and ET therapy. Logistic regression models for confounding factors adjustment showed Indian subcontinent ancestry as an independent risk factor for TSB > 25 mg/dL (OR 7.49, CI 95% [1.23–45.50]). The study group revealed also higher absolute values of TSB both at admission (22.0 mg/dL vs. 19.6 mg/dL, p  = 0.013) and at discharge (13.6 mg/dL vs. 11.4 mg/dL, p  = 0.005). Conclusion : Our findings suggest that newborns with Indian subcontinent ancestry might show a higher risk for the development of severe hyperbilirubinemia compared to European ancestry newborns. Implementing earlier treatment thresholds in this subset of patients may help prevent severe hyperbilirubinemia.  What is Known: • Indian subcontinent descendent populations have high incidence of neonatal hyperbilirubinaemia but data regarding its severity are scarce. What is New: • This article shows that, compared to European descendent newborns, Indian subcontinent descendent newborns might be at higher risk for severe hyperbilirubinaemia.