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.

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.

The Doctor Stamp and COVID-19: A Perspective.

Sources from literature and art continue to offer perspectives on episodes of collective sense of loss and despair from unavoidable tragedies. The Doctor Stamp, based on the famous painting by British artist Sir Luke Fildes (1844-1927), was issued in 1947 by the US Postal Service to commemorate the first centennial of the founding of the American Medical Association. At the time of issue, the US was in the middle of the mid-century polio epidemic. The author obtained two First Day Covers of The Doctor Stamp, one of which was addressed to Dr. George Minot, who shared the 1934 Nobel Prize in Physiology or Medicine for developing the treatment for pernicious anemia. The conjunction of these events-an anniversary, an incurable virus epidemic, and a doctor who found a treatment for a devastating condition of unknown etiology-offer those suffering from a sense of loss and despair due to COVID-19 some hopeful anticipation of better days to come.

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.

Perinatal aspects on the covid-19 pandemic: a practical resource for perinatal-neonatal specialists.

BACKGROUND: Little is known about the perinatal aspects of COVID-19. OBJECTIVE: To summarize available evidence and provide perinatologists/neonatologists with tools for managing their patients. METHODS: Analysis of available literature on COVID-19 using Medline and Google scholar. RESULTS: From scant data: vertical transmission from maternal infection during the third trimester probably does not occur or likely it occurs very rarely. Consequences of COVID-19 infection among women during early pregnancy remain unknown. We cannot conclude if pregnancy is a risk factor for more severe disease in women with COVID-19. Little is known about disease severity in neonates, and from very few samples, the presence of SARS-CoV-2 has not been documented in human milk. Links to websites of organizations with updated COVID-19 information are provided. Infographics summarize an approach to the pregnant woman or neonate with suspected or confirmed COVID-19. CONCLUSIONS: As the pandemic continues, more data will be available that could lead to changes in current knowledge and recommendations.

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.

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.

From Galen to Gross and beyond: a brief history of the enigmatic patent ductus arteriosus.

Anatomists since antiquity and pathologists since at least the 17th century had identified the ductus arteriosus (DA) in cadavers and postmortem examinations, respectively. However, healthcare providers for more than a century have struggled to understand the significance of a patent ductus arteriosus (PDA) in patients, debated whether to treat it or not and if so, when and how. Accepted answers depended upon the authoritative position of the person(s) offering recommendations, the cumulative contemporary medical knowledge, and the changing patient population characteristics. The treatment choices were most often based on one's understanding of the balance between the risks and benefits of the chosen treatment. In the current era, with the increasing popularity of transcatheter occlusion of the PDA with relative ease even in extremely premature infants whose survival rates have improved dramatically, a basic question has reemerged-what are the benefits to treating the PDA in any preterm infant. In this brief review, I am providing a chronicle of the evolution of knowledge about the DA, the varying nature of the challenges a patent ductus posed for the caregivers, and the roots of the continued debate concerning the management of the enigmatic PDA.

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.

Working Together to Address Women's Health in Research and Drug Development: Summary of the 2017 Women's Health Congress Preconference Symposium.

Historically, women have been underrepresented in clinical research, requiring physicians to extrapolate medical recommendations for women from clinical research done in cohorts consisting predominantly of male participants. While government-funded clinical research has achieved gender parity in phase-3 clinical trials across many biomedical disciplines, improvements are still needed in several facets of women's health research, such as the inclusion of women in early-phase clinical trials, the inclusion of pregnant women and women with physical and intellectual disabilities, the consideration of sex as a biological variable in preclinical research, and the analysis and reporting of sex and gender differences across the full biomedical research continuum. The National Institutes of Health (NIH) Office of Research on Women's Health and the Office of Women's Health of the U.S. Food and Drug Administration (FDA) cosponsored a preconference symposium at the 25th Annual Women's Health Congress, held in Arlington, VA in April, 2017, to highlight gains made and remaining needs regarding the representation of women in clinical research, to introduce innovative procedures and technologies, and to outline revised policy for future studies. Six speakers presented information on a range of subjects related to the representation of women in clinical research and federal initiatives to advance precision medicine. Topics included the following: the return on investment from the NIH-funded Women's Health Initiative; progress in including women in clinical trials for FDA-approved drugs and products; the importance of clinical trials in pregnant women; FDA initiatives to report drug safety during pregnancy; the NIH-funded All of Us Research Program; and efforts to enhance FDA transparency and communications, including the introduction of Drug Trials Snapshots. This article summarizes the major points of the presentations and the discussions that followed.

Anhydramnios in the Setting of Renal Malformations: The National Institutes of Health Workshop Summary.

Anhydramnios in the setting of severe malformations of the fetal kidney and urinary tract is associated with a high incidence of stillbirths and life-threatening complications, including severe pulmonary hypoplasia, umbilical cord compression, and perinatal asphyxia. To prevent such adverse outcomes, some centers in the United States and elsewhere are offering amniotic fluid restoration for women diagnosed with anhydramnios in the setting of fetal renal malformations. The procedures include infusions of amniotic fluid substitutes (normal saline), percutaneously or through an amnioport-an implanted system for serial or continuous infusion of normal saline to maintain the desired amniotic fluid volume. The procedures are intended to prevent pulmonary hypoplasia and allow the pregnancy to progress closer to term gestation, enabling postnatal renal management, including long-term dialysis and renal transplantation. However, these procedures have not been recommended as standard of care by the professional societies because there are many knowledge gaps, including few data on short-term and long-term renal outcomes. The available diagnostic methods do not provide reliable prognostic information, and the current maternal and fetal interventions have not been standardized. To address these unresolved issues and to propose a research agenda, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Diabetes and Digestive and Kidney Diseases invited a panel of experts to a workshop in August 2016. This report provides a summary of that meeting.

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.