HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens

项目摘要/摘要 怀孕期间阿片类药物的使用很普遍，并与两个孕妇的不良后果有关 个人和发育中的儿童。产前阿片类药物暴露与广泛的阴性胎儿相关 以及儿童结局，包括胎儿发育迟缓、早产、出生体重降低、先天缺陷、 增加新生儿保健，增加后来行为(如焦虑、注意力不集中)、认知 (例如，记忆缺陷、语言习得延迟)和新陈代谢问题。尽管阿片类药物的使用与 对母亲、胎儿和儿童的不良结局，产生这些后果的机制和潜在的 产前阿片类药物暴露对儿童健康和发育(如大脑和行为)的影响仍然存在 很大程度上是未被开发的。这种病因学知识的缺乏导致了治疗、预防和治疗的停滞 缓解努力使个人和家庭容易受到不良后果的影响。 健康大脑和儿童发展(HBCD)研究是一项25个地点的纵向前瞻性研究 美国早期儿童发展将评估广泛的生物学(例如，神经成像、遗传学、 表观遗传学)、行为(例如认知和情绪调节)、经验(例如创伤)、社会(例如， 在约7,500名具有全国代表性的孕妇中调查了健康(例如，精神病理学)因素 以及他们的孩子从怀孕到童年中期。HBCD研究的一个主要目标是增加 了解产前接触物质的潜在后果。研究人群将是 孕妇在怀孕期间使用丰富的物质(即，约25%的样本将使用阿片类药物， 怀孕期间使用大麻、酒精和/或烟草，总样本的12%将使用阿片类药物)和 提供了一个独特的机会，让我们了解与 怀孕期间会出现阿片类药物的使用。尽管HBCD将是对早期大脑和儿童的最大规模的长期研究 根据美国的发展成果，核心议定书不包括收集递送生物杀虫剂。 本行政副刊是为回应NIDA/ORWH的特别行政副刊通知 兴趣：Hear倡议：孕期生物素收集(Not-DA-23-005)建议利用 通过扩大核心生物样品集进行健康脑和儿童发育(HBCD)研究 HBCD方案包括分娩标本(胎盘、脐带组织和脐带血)。送货 样本将从HBCD研究参与者的代表性样本中收集，涉及多达14个地点(和 HBCD网站上的2,000多名参与者提交了对这一NOSI的申请)。这将提供 为更大的科学界提供前所未有的资源创造机会，以全面 评估调节阿片类药物和多物质使用之间联系的病理生理机制 在怀孕期间和不利的新生儿、婴儿、儿童和/或产妇的健康结果，反过来，通知 创新预防战略。

PROJECT SUMMARY/ABSTRACT Opioid use during pregnancy is widespread and associated with adverse outcomes for both 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. The study population will be enriched for maternal substance use during pregnancy (i.e., ~25% of the sample will have used opioids, cannabis, alcohol, and/or tobacco during pregnancy and 12% of the total sample will have used 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) Study by expanding the biospecimen collection of the Core HBCD Protocol to include delivery specimens (placenta, umbilical cord tissue, and 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 the larger scientific community to comprehensively evaluate pathophysiological mechanisms that mediate the connection between opioid and polysubstance use during pregnancy and adverse neonatal, infant, child, and/or maternal health outcomes and, in turn, inform innovative preventive strategies.