PROJECT SUMMARY/ABSTRACT
Opioid use during pregnancy is widespread and associated with adverse outcomes for the pregnant individual
and the developing child. Prenatal opioid exposure is associated with a wide range of negative fetal and child
outcomes including reduced fetal growth, premature birth, lower birth weight, congenital defects, increased
neonatal healthcare, and heightened risk for later behavioral (e.g., anxiety, inattention), cognitive (e.g., memory
deficits, delayed language acquisition), and metabolic problems. Despite opioid use being linked to adverse
maternal, fetal, and child outcomes, the mechanisms through which these arise and the potential consequences
of prenatal opioid exposure for child health and development (e.g., brain and behavior) remain largely
unexplored. This lack of etiologic knowledge has contributed to stagnant treatment, prevention, and mitigation
efforts leaving individuals and families susceptible to reverberating adverse outcomes.
The HEALthy Brain and Child Development (HBCD) Study is a 25-site longitudinal prospective study of
early child development in the US that will assess a broad spectrum of biological (e.g., neuroimaging, genetics,
epigenetics), behavioral (e.g., cognition and emotional regulation), experiential (e.g., trauma), social (e.g.,
racism), and health (e.g., psychopathology) factors among ~7,500 nationally-representative pregnant women
and their children from pregnancy to mid-childhood. A major goal of the HBCD study is to increase understanding
of the potential consequences of prenatal substance exposures. It will be enriched for maternal substance use
during pregnancy (i.e., ~25% of the sample will be using opioids, cannabis, alcohol, and/or tobacco during
pregnancy and 12% of the total sample will be using opioids) and offers a unique opportunity to inform our
understanding of how the adverse consequences associated with opioid use during pregnancy arise. Although
HBCD will be the largest long-term study of early brain and child development outcomes in the US, the core
protocol does not include the collection of delivery biospecimens. This Administrative Supplement in response
to the NIDA/ORWH Administrative Supplement Notice of Special Interests: HEAL Initiative: Biospecimen
Collection in Pregnancy (NOT-DA-23-005) proposes to leverage the HEALthy Brain and Child Development
(HBCD) by expanding the biospecimen collection of the Core HBCD Protocol to include delivery specimens
(placenta, cord tissue, cord blood). Delivery samples will be collected from a representative sample of HBCD
Study participants across up to 14 sites (and over 2,000 participants across HBCD sites submitting applications
in response to this NOSI). This will provide an unprecedented resource generating opportunity for a larger
scientific community to comprehensively evaluate pathophysiological mechanisms that mediate the connection
between opioid and polysubstance use during pregnancy and adverse neonatal, infant, and/or maternal health
outcomes and, in turn, inform innovative preventive strategies.