Funded Projects

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The University of Florida study site will recruit a diverse group of mother-infant pairs from urban and rural communities in North Central Florida.

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.

The HEALthy Brain and Child Development National Consortium (HBCD-NC) Administrative Core (HCAC) will coordinate efforts across all sites in the HBCD-NC consortium to ensure that the consortium meets its primary objective to establish a normative model of developmental trajectories over the first 10 years of life. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HCAC will oversee study design and monitor the progress of each site’s ability to carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. This administrative core is located at the University of California, San Diego.

A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. Five institutions (Duke University, Arkansas Children’s Research Institute, Cincinnati Children’s Hospital, University of Illinois at Urbana–Champaign, and University of North Carolina at Chapel Hill) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study.

Prevalence rates of opioids misuse in Los Angeles County (LA) are particularly high among individuals of childbearing age and in already-vulnerable populations including African American females. These data highlight a pressing need for a systematic study of the effects of prenatal drug exposures (PDE) in the unique sociodemographic LA County area. In this project, researchers aim to establish the feasibility for the large-scale Phase II HEALthy BCD study in the Los Angeles area with three specific aims: (1) build a broad interdisciplinary team of investigators capable of a multi-faceted study of brain and behavioral development in both typically developing and at-risk infants/children; (2) establish a set of highly executable recruitment and retention strategies for both drug-free and drug-exposed infants/children; and (3)establish comprehensive study protocols that will help address the three key research objectives of the Phase II study.

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive and well curated research dataset to the scientific community at large. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The Children’s Hospital of Los Angeles study site will enroll participants from across the Greater Los Angeles region, where the prevalence of legal and illegal non-opioid drug use is high, enabling researchers to recruit from diverse, high-risk populations.

The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids.

The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids.

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will take place at the University of Minnesota and will provide access to a largely rural population.

Rates of neonatal abstinence syndrome have reached a staggering 6.5 per 1,000 births nationwide, creating an urgent need to identify how in-utero exposure to opioids and associated risk factors influence the developing brain. A multidisciplinary team will address these challenges in Oregon, a state particularly hard hit by the opioid epidemic. Through linking sites, the impact of the Phase I project is enhanced and will provide critical information to support a national-level effort for Phase II of the HEALthy Brain and Child Development Study. Aim 1 will develop, implement, and evaluate innovative recruitment and retention strategies for high-risk populations. Aim 2 will address anticipated challenges of the planned Phase II study by implementing and evaluating a multi-site, standardized research protocol including multimodal MRI of placenta, fetus, neonate, and 24-month-old brain; biospecimen collection; and assessment of substance use and other key domains. Aim 3 will evaluate data acquisition, processing, and statistical considerations to maximize data quality, usability, and integration across sites.

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.

Rates of neonatal abstinence syndrome have reached a staggering 6.5 per 1,000 births nationwide, creating an urgent need to identify how in-utero exposure to opioids and associated risk factors influence the developing brain. A multidisciplinary team will address these challenges in Oregon, a state particularly hard hit by the opioid epidemic. Through linking sites, the impact of the Phase I project is enhanced and will provide critical information to support a national-level effort for Phase II of the HEALthy Brain and Child Development Study. Aim 1 will develop, implement, and evaluate innovative recruitment and retention strategies for high-risk populations. Aim 2 will address anticipated challenges of the planned Phase II study by implementing and evaluating a multi-site, standardized research protocol including multimodal MRI of placenta, fetus, neonate, and 24-month-old brain; biospecimen collection; and assessment of substance use and other key domains. Aim 3 will evaluate data acquisition, processing, and statistical considerations to maximize data quality, usability, and integration across sites.

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will take place at Oregon Health and Science University, giving researchers access to people in a region with very high rates of opioid misuse.