The Healthy Brain and Child Development National Consortium Administrative Core

项目总结/摘要 妊娠期间使用阿片类药物很普遍，并与妊娠个体的不良结局相关 和发育中的儿童，包括胎儿生长减少，早产，出生体重较低，先天性缺陷， 增加新生儿保健，以及增加以后行为的风险（例如，焦虑，注意力不集中），认知（例如， 记忆缺陷、语言习得延迟）和代谢问题。尽管阿片类药物的使用与 不利的孕产妇，胎儿和儿童的结果，通过这些产生的机制和潜在的 产前阿片类药物暴露对儿童健康和发育的影响（例如，大脑和行为）仍然存在 大部分未开发。缺乏病因学知识导致了治疗、预防和治疗的停滞， 缓解努力使个人和家庭容易受到负面影响。健康 脑与儿童发育（HBCD）研究是一项针对儿童早期发育的25个研究中心的纵向前瞻性研究 在美国，将评估广泛的生物学（例如，神经影像学、遗传学、表观遗传学）、行为 (e.g.,认知和情绪调节），经验的（例如，创伤），社会（例如，种族主义）和健康（例如， 在约7，500名全国代表性孕妇及其子女中， 怀孕到童年中期。六溴环十二烷研究的一个主要目标是增加对六溴环十二烷潜在 产前物质暴露的后果。它将被丰富的母亲物质使用在怀孕期间 (i.e.,约25%的样本将在怀孕期间使用阿片类药物，大麻，酒精和/或烟草），并提供 这是一个独特的机会，让我们了解与阿片类药物使用相关的不良后果是如何发生的。 在怀孕期间出现。尽管六溴环十二烷将是对早期大脑和儿童发育的最大规模的长期研究， 在美国，核心方案不包括分娩生物标本的采集。这 对NIDA/ORWH特别行政补充通知的行政补充 兴趣：HEAL倡议：妊娠期生物标本采集（NOT-DA-23-005）建议利用 六溴环十二烷研究，扩大核心六溴环十二烷议定书的生物标本采集范围，将分娩标本包括在内 （胎盘、脐带组织、脐带血）。将从六溴环十二烷研究参与者样本中采集分娩样本 在多达14个六溴环十二烷生产基地（包括2，000多名参与者）， 对这个问题的回答。这将为更大的国家提供前所未有的资源产生机会， 科学界全面评估介导这种联系的病理生理机制 妊娠期间使用阿片类药物和多种物质与新生儿、婴儿和/或孕产妇健康不良之间的关系 这将有助于取得成果，并反过来为创新的预防战略提供信息。

PROJECT SUMMARY/ABSTRACT Opioid use during pregnancy is widespread and associated with adverse outcomes for the pregnant individual and the developing child, 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 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 Interest: HEAL Initiative: Biospecimen Collection in Pregnancy (NOT-DA-23-005) proposes to leverage the HBCD Study 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 sample of HBCD Study participants across up to 14 HBCD sites (encompassing over 2,000 participants) who have submitted applications in response to this NOSI. This will provide an unprecedented resource generating opportunity for the 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.