Principles and Practices of Returning Individual Research Results to Participants in Large Studies of Pregnancy and Childhood.

Investigators conducting human subject research have typically conveyed only clinically actionable results back to individual participants. Shifting scientific culture around viewing participants as partners in research, however, is prompting investigators to consider returning as much data or results as the participant would like, even if they are not clearly actionable. Expanding return of individual results may add value for individual participants and their communities, refine future research questions and methods, build trust, and enhance retention of participants. Yet, gaps remain in understanding the implications of these changes for groups of 'vulnerable' participants, including pregnant and pediatric participants. We present the findings of a National Institutes of Health workshop on returning individual research results, particularly as applicable to pregnant and pediatric participants. Research participants who were panelists at the workshop agreed that they desire to receive their results. Workshop findings and current literature indicate that participants have differing preferences for what results they receive. One way to address the limits of current practice is to develop flexible digital platforms that convey individual results along with researchers' availability to answer questions, and to provide as much information as possible about actionable steps to control environmental exposures associated with disease risk.

Opportunities for the federal government to advance necrotizing enterocolitis research.

BACKGROUND: Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality in the neonatal ICU with minimal progress in the research. METHODS: Federal webpages were queried to look for funding opportunity announcements (FOAs) and to develop lists of funded projects on NEC to identify gaps in NEC-related research topics. RESULTS: Over the past 30 years, the National Institutes of Health (NIH) issued two FOAs to stimulate research on NEC with $4.1 million set aside for the first year of respective funding. We identified 23 recently funded studies of which 18 were research projects, 4 training grants, and 1 conference grant support. Only one grant focused on parent and family engagement in the NICU. CONCLUSION: There are significant research gaps that can be addressed with adequate funding from the federal government on the prevention and treatment of NEC.

Neighbourhood-level deprivation indices and postpartum women's health: results from the Community Child Health Network (CCHN) multi-site study.

BACKGROUND: Area-level socioeconomic characteristics have been shown to be related to health status and mortality however, little is known about the association between residential community characteristics in relation to postpartum women's health. METHODS: Data from the longitudinal, multi-site Community Child Health Network (CCHN) study were used. Postpartum women (n = 2510), aged 18-40 were recruited from 2008 to 2012 within a month of delivery. Socioeconomic data was used to create deprivation indices. Census data were analysed using principal components analysis (PCA) and logistic regression to assess the association between deprivation indices (DIs) and various health indicators. RESULTS: PCA resulted in two unique DIs that accounted for 67.5% of the total variance of the combined all-site area deprivation. The first DI was comprised of variables representing a high percentage of Hispanic or Latina, foreign-born individuals, dense households (more than one person per room of residence), with less than a high-school education, and who spent more than 30% of their income on housing costs. The second DI was comprised of a high percentage of African-Americans, single mothers, and high levels of unemployment. In a multivariate logistic regression model, using the quartiles of each DI, women who reside in the geographic area of Q4-Q2 of the second DI, were almost twice as likely to have more than three adverse health conditions compared to those who resided in the least deprived areas. (Q2vs.Q1:OR = 2.09,P = 0.001,Q3vs.Q1:OR = 1.89,P = 0.006,Q4vs.Q1:OR = 1.95,P = 0.004 respectively). CONCLUSIONS: Our results support the utility of examining deprivation indices as predictors of maternal postpartum health.

Cardiovascular and Metabolic Risk in Women in the First Year Postpartum: Allostatic Load as a Function of Race, Ethnicity, and Poverty Status.

OBJECTIVE: Allostatic load (AL) represents multisystem physiological "wear-and-tear" reflecting emerging chronic disease risk. We assessed AL during the first year postpartum in a diverse community sample with known health disparities. STUDY DESIGN: The Eunice Kennedy Shriver National Institute for Child Health and Human Development Community Child Health Network enrolled 2,448 predominantly low-income African-American, Latina, and White women immediately after delivery of liveborn infants at ≥20 weeks' gestation, following them over time with interviews, clinical measures, and biomarkers. AL at 6 and 12 months postpartum was measured by body mass index, waist:hip ratio, blood pressure, pulse, hemoglobin A1c, high-sensitive C-reactive protein, total cholesterol and high-density lipoprotein, and diurnal cortisol slope. RESULTS: Adverse AL health-risk profiles were significantly more prevalent among African-American women compared with non-Hispanic Whites, with Latinas intermediate. Breastfeeding was protective, particularly for White women. Complications of pregnancy were associated with higher AL, and disparities persisted or worsened through the first year postpartum. CONCLUSION: Adverse AL profiles occurred in a substantial proportion of postpartum women, and disparities did not improve from birth to 1 year. Breastfeeding was protective for the mother.

Adults born preterm: a review of general health and system-specific outcomes.

In this review of 126 publications, we report that an overwhelming majority of adults born at preterm gestations remain healthy and well. However, a small, but a significant fraction of them remain at higher risk for neurological, personality and behavioural abnormalities, cardio-pulmonary functional limitations, systemic hypertension and metabolic syndrome compared to their term-born counterparts. The magnitude of increased risk differed across organ systems and varied across reports. The risks were proportional to the degree of prematurity at birth and seemed to occur more frequently among preterm infants born in the final two decades of the 20th century and later. These findings have considerable public health and clinical practice relevance. CONCLUSION: Preterm birth needs to be considered a chronic condition, with a slight increase in the risk for long-term morbidities among adults born preterm. Therefore, obtaining a history of gestational age and weight at birth should be a routine part of care for patients of all age groups.

The Preconception Stress and Resiliency Pathways Model: a multi-level framework on maternal, paternal, and child health disparities derived by community-based participatory research.

Emerging evidence supports the theoretical and clinical importance of the preconception period in influencing pregnancy outcomes and child health. Collectively, this evidence affirms the need for a novel, integrative theoretical framework to design future investigations, integrate new findings, and identify promising, evidence-informed interventions to improve intergenerational health and reduce disparities. This article presents a transdisciplinary framework developed by the NIH Community Child Health Network (CCHN) through community-based participatory research processes. CCHN developed a Preconception Stress and Resiliency Pathways (PSRP) model by building local and multi-site community-academic participatory partnerships that established guidelines for research planning and decision-making; reviewed relevant findings diverse disciplinary and community perspectives; and identified the major themes of stress and resilience within the context of families and communities. The PSRP model focuses on inter-relating the multiple, complex, and dynamic biosocial influences theoretically linked to family health disparities. The PSRP model borrowed from and then added original constructs relating to developmental origins of lifelong health, epigenetics, and neighborhood and community influences on pregnancy outcome and family functioning (cf. MCHJ 2014). Novel elements include centrality of the preconception/inter-conception period, role of fathers and the parental relationship, maternal allostatic load (a composite biomarker index of cumulative wear-and-tear of stress), resilience resources of parents, and local neighborhood and community level influences (e.g., employment, housing, education, health care, and stability of basic necessities). CCHN's integrative framework embraces new ways of thinking about how to improve outcomes for future generations, by starting before conception, by including all family members, and by engaging the community vigorously at multiple levels to promote resiliency, reduce chronic and acute stressors, and expand individualized health care that integrates promotive and prevention strategies. If widely adopted, the PSRP model may help realize the goal of sustaining engagement of communities, health and social services providers, and scientists to overcome the siloes, inefficiencies, and lack of innovation in efforts to reduce family health disparities. Model limitations include tremendous breadth and difficulty measuring all elements with precision and sensitivity.

Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists.

This is an executive summary of a workshop on the management and counseling issues of women anticipated to deliver at a periviable gestation (broadly defined as 20 0/7 through 25 6/7 weeks of gestation) and the treatment options for the newborn infant. Upon review of the available literature, the workshop panel noted that the rates of neonatal survival and neurodevelopmental disabilities among the survivors vary greatly across the periviable gestations and are significantly influenced by the obstetric and neonatal management practices (eg, antenatal steroid, tocolytic agents, and antibiotic administration; cesarean birth; and local protocols for perinatal care, neonatal resuscitation, and intensive care support). These are, in turn, influenced by the variations in local and regional definitions of limits of viability. Because of the complexities in making difficult management decisions, obstetric and neonatal teams should confer prior to meeting with the family, when feasible. Family counseling should be coordinated with the goal of creating mutual trust, respect, and understanding and should incorporate evidence-based counseling methods. Since clinical circumstances can change rapidly with increasing gestational age, counseling should include discussion of the benefits and risks of various maternal and neonatal interventions at the time of counseling. There should be a plan for follow-up counseling as clinical circumstances evolve. The panel proposed a research agenda and recommended developing educational curricula on the care and counseling of families facing the birth of a periviable infant.

Timing of umbilical cord clamping after birth for optimizing placental transfusion.

PURPOSE OF REVIEW: A brief delay in clamping the umbilical cord after birth offers health benefits to the newborn, with no adverse effects to the mother or her infant. Yet, in most obstetric practice, the cord is clamped soon after birth. A summary of the current evidence on delayed cord clamping and some reasons for the disconnect between the evidence and practice are discussed here, along with the recommendations from professional organizations and societies about this practice. RECENT FINDINGS: In term infants, umbilical cord clamping between 30 and 180 s after birth results in higher concentrations of hemoglobin and hematocrit during the neonatal period, and increased serum ferritin levels and a lower incidence of iron-deficiency anemia at 4-6 months of age. These are important benefits for children in low and middle income countries where iron-deficiency anemia is highly prevalent. In preterm infants, delayed cord clamping for at least 30 s increases the concentrations of hemoglobin and hematocrit, improves mean systemic blood pressure, urine output, and cardiac function, and decreases the need for vasopressors and blood transfusions during the neonatal period. It also decreases the prevalence of necrotizing enterocolitis, sepsis, and intraventricular hemorrhage (all grades). Milking of the unclamped umbilical cord toward the infant soon after birth also has similar beneficial effects. In some studies, more infants in the delayed cord clamping groups required phototherapy for jaundice. SUMMARY: Many professional organizations, societies, and experts recommend at least a 30-s delay before clamping the umbilical cord, especially after preterm births. The value of this practice for term births in resource-rich settings has not been evaluated.

Achieving healthy people 2030 breastfeeding targets in the United States: challenges and opportunities.

OBJECTIVES: To estimate the national and states-specific gaps in breastfeeding rates in the United States for achieving the Healthy People 2030 (HP2030) targets, which are: 42.4% of infants to exclusively breastfeed through 6th months, and 54.1% of infants to breastfeed through 12th month of age. STUDY DESIGN: The differences between the HP2030 breastfeeding targets and the respective state-specific baseline rates in the 2022 National Immunization Survey report for infants born in 2019 were computed. RESULTS: The gaps in breastfeeding rates for achieving either of the two HP2030 targets varied greatly. Relative to their 2019 baseline estimates, 7 U.S. states need to increase breastfeeding rates between 100% and 207%, 27 states between 50% and 99%, 9 states and 2 territories between 20% and 49% and the remaining 7, between 0% and 19%. CONCLUSIONS: Thirty-four of 50 (68%) states face huge gaps in achieving the HP2030 breastfeeding targets.

Neonatal mortality by attempted route of delivery in early preterm birth.

OBJECTIVE: We sought to study neonatal outcomes in early preterm births by delivery route. STUDY DESIGN: Delivery precursors were analyzed in 4352 singleton deliveries, 24 0/7 to 31 6/7 weeks' gestation. In a subset (n = 2906) eligible for a trial of labor, neonatal mortality in attempted vaginal delivery (VD) was compared to planned cesarean delivery stratified by presentation. RESULTS: Delivery precursors were classified as maternal or fetal conditions (45.7%), preterm premature rupture of membranes (37.7%), and preterm labor (16.6%). For vertex presentation, 79% attempted VD and 84% were successful. There was no difference in neonatal mortality. For breech presentation, at 24 0/7 to 27 6/7 weeks' gestation, 31.7% attempted VD and 27.6% were successful; neonatal mortality was increased (25.2% vs 13.2%, P = .003). At 28 0/7 to 31 6/7 weeks' gestation, 30.5% attempted VD and 17.2% were successful; neonatal mortality was increased (6.0% vs 1.5%, P = .016). CONCLUSION: Attempted VD for vertex presentation has a high success rate with no difference in neonatal mortality unlike breech presentation.

Patient safety in the context of neonatal intensive care: research and educational opportunities.

Case reports and observational studies continue to report adverse events from medical errors. However, despite considerable attention to patient safety in the popular media, this topic is not a regular component of medical education, and much research needs to be carried out to understand the causes, consequences, and prevention of healthcare-related adverse events during neonatal intensive care. To address the knowledge gaps and to formulate a research and educational agenda in neonatology, the Eunice Kennedy Shriver National Institute of Child Health and Human Development invited a panel of experts to a workshop in August 2010. Patient safety issues discussed were the reasons for errors, including systems design, working conditions, and worker fatigue; a need to develop a "culture" of patient safety; the role of electronic medical records, information technology, and simulators in reducing errors; error disclosure practices; medicolegal concerns; and educational needs. Specific neonatology-related topics discussed were errors during resuscitation, mechanical ventilation, and performance of invasive procedures; medication errors including those associated with milk feedings; diagnostic errors; and misidentification of patients. This article provides an executive summary of the workshop.

Naming Mount Barcroft.

Background: The University of California White Mountain Research Center is located on Mount Barcroft, a 13,040-ft (3975-m) peak on the California White Mountain range. This report describes how the peak got its name honoring Sir Joseph Barcroft of Great Britain. Materials and Methods: Several publicly available webpages were the sources for this study. Results: On October 16, 1951, the United States Board on Geographic Names approved "Mount Barcroft" as the name for a peak on the California White Mountain range enabling the building of a facility dedicated to high-altitude research. The process of naming, however, was far from smooth. Objections came from the members of the Sierra Club, editors of a local newspaper, and a few citizens of California delaying the approval process. At least six other names had been proposed, three of which were from a Native American Indian language. Those who opposed the name "Mount Barcroft" argued that Barcroft never visited the United States, let alone the White Mountain region, and there was a paucity of Native American Indian names for geographic features in the United States. Conclusions: Despite oppositions and controversies, however, a much-deserved scientist was duly honored by an agency of the United States federal government.

Safe and effective devices and instruments for use in the neonatal intensive care units: NICHD Workshop summary.

The neonatal intensive care unit (NICU) depends heavily on advanced biomedical devices for monitoring, diagnosis, and treatment. Developing safe and effective devices for use in the NICU requires collaborative research and testing efforts between the bioengineering and biomedical disciplines. However, no mechanism exists to match the needs of the clinical community and the efforts of the bioengineering community. To address this issue, in February 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) invited a team of experts from diverse fields of biomedicine and bioengineering to participate in a workshop. The team reviewed and summarized bioinstrumentation needs and proposed a research agenda to develop safe and effective devices and instruments. The discussants addressed topics in cardiopulmonary, cerebrovascular, metabolic, and infectious conditions of the neonate. The authors provide a summary of the workshop discussions in this paper.