Neurobehavioral Profiles in Opioid-Exposed and Unexposed Neonates.

Objective: To describe distinctive profiles of neurobehavior in opioid-exposed and unexposed neonates.

Study Design: The Outcomes of Babies with Opioid Exposure (OBOE) study is a multisite, prospective, observational study in neonates born at term with opioid exposure and unexposed controls. As part of the OBOE study protocol, certified examiners administered the NeoNatal Neurobehavioral Scales, 2 edition (NNNS-II) before 6 weeks postnatal age.

Supplementing Consent for a Prospective Longitudinal Cohort Study of Infants With Antenatal Opioid Exposure: Development and Assessment of a Digital Tool.

Background: The Outcomes of Babies With Opioid Exposure (OBOE) study is an observational cohort study examining the impact of antenatal opioid exposure on outcomes from birth to 2 years of age. COVID-19 social distancing measures presented challenges to research coordinators discussing the study at length with potential participants during the birth hospitalization, which impacted recruitment, particularly among caregivers of unexposed (control) infants. In response, the OBOE study developed a digital tool (consenter video) to supplement the informed consent process, make it more engaging, and foster greater identification with the research procedures among potential participants.

The Relationship Between Hispanic Ethnicity and Outcomes for Infants Born Extremely Preterm.

Objective: To characterize the association between maternal ethnicity and infant survival to discharge without major morbidity.

Study Design: This is secondary analysis of a prospective cohort of infants born <27 weeks of gestation at National Institute of Child Health and Human Development Neonatal Research Network centers from 2006 through 2020. The primary outcome was survival to discharge without major morbidity (sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia grade 3, intracranial hemorrhage grade ≥3, periventricular leukomalacia, and advanced retinopathy of prematurity).

Lessons Learned in Virtual Launch of an Antenatal Opioid Exposure Study During the COVID-19 Pandemic.

Background: The COVID-19 pandemic prompted researchers to develop new ways to design and launch studies and recruit and retain participants. Pregnant women and infants are considered vulnerable populations in research, and families affected by substance use are particularly difficult to recruit and retain. Recruitment for studies involving medical technologies such as MRI can also be difficult due to misconceptions and fear of the technologies.

Design and implementation of a multicenter protocol to obtain impulse oscillometry data in preterm children.

Importance: Objective measures of lung function are critical for assessing respiratory outcomes of prematurity. Among extremely low gestational age neonates (ELGANs) (< 29 weeks gestational age), high rates of neurodevelopmental impairment may interfere with lung function testing. Impulse oscillometry (IOS) is a noninvasive test of respiratory system mechanics not requiring forced expiration.

Integration of Peer Navigators Into Longitudinal Research.

Objective: To assess consent rates and reasons for refusing consent after the introduction of peer navigators into the Outcomes of Babies With Opioid Exposure (OBOE) Study.

Design: Secondary analysis of data from the OBOE Study, a multisite observational study.

Setting: Medical centers in Alabama, Ohio, and Pennsylvania (N = 4).

The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study.

Background: Bronchopulmonary dysplasia (BPD) affects up to half of extremely preterm infants, and is associated with adverse long-term respiratory, neurodevelopmental, and educational sequelae and costly health service and family economic outcomes. The NICHD Neonatal Research Network Hydrocortisone for Bronchopulmonary Dysplasia (BPD) Trial evaluated the efficacy and safety of hydrocortisone treatment to prevent BPD in high-risk infants. The trial enrolled 800 very preterm infants with respiratory failure and followed the participants until 2 years corrected age to assess safety of the trial intervention.

Risk Assessment of Cognitive Impairment at 2 Years of Age in Infants Born Extremely Preterm Using the INTERGROWTH-21st Growth Standards.

Objective: To assess the risk of cognitive impairment among infants born extremely preterm using the INTERGROWTH-21st standards.

Study Design: We analyzed anthropometric data at birth and 36 weeks postmenstrual age (PMA) from infants born extremely preterm (24-26 weeks of gestation) admitted to US neonatal units between 2008 and 2018. To determine INTERGROWTH-21st z-score values that indicate an increased risk of cognitive impairment at 2 years of age (Bayley cognitive score <85), we employed classification and regression trees and redefined growth failure (weight, length, and head circumference z-scores at 36 weeks PMA) and growth faltering (weight, length, and head circumference z-score declines from birth to 36 weeks PMA).

Adapting a health facility HIV stigma-reduction participatory training intervention to address drug use stigma in HIV care and treatment clinics in Dar es Salaam, Tanzania.

Background: HIV prevalence among people who use drugs (PWUD) in Tanzania is 4-7 times higher than in the general population, underscoring an urgent need to increase HIV testing and treatment among PWUD. Drug use stigma within HIV clinics is a barrier to HIV treatment for PWUD, yet few interventions to address HIV-clinic drug use stigma exist. Guided by the ADAPT-ITT model, we adapted the participatory training curriculum of the evidence-based Health Policy Plus Total Facility Approach to HIV stigma reduction, to address drug use stigma in HIV care and treatment clinics (CTCs).

Social Determinants of Health and Redirection of Care for Infants Born Extremely Preterm.

Importance: Redirection of care refers to withdrawal, withholding, or limiting escalation of treatment. Whether maternal social determinants of health are associated with redirection of care discussions merits understanding.

Objective: To examine associations between maternal social determinants of health and redirection of care discussions for infants born extremely preterm.

Psychometric Assessment of the Rett Syndrome Caregiver Assessment of Symptom Severity (RCASS).

Rett syndrome is a severe neurodevelopmental disorder that affects about 1 in 10,000 females. Clinical trials of disease modifying therapies are on the rise, but there are few psychometrically sound caregiver-reported outcome measures available to assess treatment benefit. We report on a new caregiver-reported outcome measure, the Rett Caregiver Assessment of Symptom Severity (RCASS).

Psychological distress among postpartum women who took opioids during pregnancy: the role of perceived stigma in healthcare settings.

This study examined the relationship between perceived stigma in healthcare settings during pregnancy and psychological distress and well-being in the postpartum period among individuals who took opioids while pregnant. Analyses included 134 birth mothers of opioid-exposed infants. At 0-1 months postpartum, perceived stigma and psychological distress were measured using the Prenatal Opioid use Perceived Stigma scale and measures from the Patient-Reported Outcome Measurement Information System (PROMIS).

Can the date of last menstrual period be trusted in the first trimester? Comparisons of gestational age measures from a prospective cohort study in six low-income to middle-income countries.

Objectives: We examined gestational age (GA) estimates for live and still births, and prematurity rates based on last menstrual period (LMP) compared with ultrasonography (USG) among pregnant women at seven sites in six low-resource countries.

Design: Prospective cohort study SETTING AND PARTICIPANTS: This study included data from the Global Network's population-based Maternal and Newborn Health Registry which follows pregnant women in six low-income and middle-income countries (Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan and Zambia). Participants in this analysis were 42 803 women, including their 43 230 babies, who registered for the study in their first trimester based on GA estimated either by LMP or USG and had a live or stillbirth with an estimated GA of 20-42 weeks.

The PURPOSe cause of death study in stillbirths and neonatal deaths in India and Pakistan: A review.

The PURPOSe study was a prospective, observational study conducted in India and Pakistan to determine the cause of death for stillbirths and preterm neonatal deaths, using clinical data together with minimally invasive tissue sampling (MITS) and the histologic and polymerase chain reaction (PCR) evaluation of fetal/neonatal tissues and the placenta. After evaluating all available data, an independent panel chose a maternal, a placental and a fetal/neonatal cause of death. Here, we summarise the major results.

Trends over time in the knowledge, attitude and practices of pregnant women related to COVID-19: A cross-sectional survey from seven low- and middle-income countries.

Objective: To understand trends in the knowledge, attitudes and practices (KAP) of pregnant women related to COVID-19 in seven low- and middle-income countries.

Design: Multi-country population-based prospective observational study.

Setting: Study sites in Bangladesh, the Demographic Republic of Congo (DRC), Guatemala, India (two sites), Kenya, Pakistan and Zambia.

Use of term reference infants in assessing the developmental outcome of extremely preterm infants: lessons learned in a multicenter study.

Objective: Extremely preterm (EP) impairment rates are likely underestimated using the Bayley III norm-based thresholds scores and may be better assessed relative to concurrent healthy term reference (TR) infants born in the same hospital.

Study Design: Blinded, certified examiners in the Neonatal Research Network (NRN) evaluated EP survivors and a sample of healthy TR infants recruited near the 2-year assessment age.

Results: We assessed 1452 EP infants and 183 TR infants.

Pregnancy outcomes in preterm multiple gestations: Results from a prospective study in India and Pakistan (PURPOSe).

Objective: To evaluate perinatal outcomes in preterm multiple compared with singleton pregnancies in India and Pakistan.

Design: Prospective, observational study.

Settings: Study hospitals in India and Pakistan.

Neonatal mortality among preterm infants admitted to neonatal intensive care units in India and Pakistan: A prospective study.

Objective: To explore potential reasons for differences in preterm neonatal mortality in neonatal intensive care units (NICUs) in India and Pakistan.

Design: A prospective observational study, the Project to Understand and Research Stillbirth and Preterms in Southeast Asia (PURPOSe) was conducted July 2018 to February 2020.

Setting: Three hospitals in Davangere, India, and a large public hospital in Karachi, Pakistan.

Integrated Early Childhood Development in Cambodia: Protocol of a Cluster Stepped-Wedge Trial.

Objectives: Limited evidence is available on mechanisms linking integrated, multisector interventions with early childhood development. The Integrated Early Childhood Development program aims to improve children's development by promoting targeted caregiving behaviors beginning prenatally through age 5 years, in partnership with the Royal Government of Cambodia.

Methods: This cluster stepped-wedge trial is being conducted in Cambodia among 3 cohorts, encompassing 339 villages and 1790 caregivers who are pregnant or caring for a child aged <5 years.