HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens

六溴环十二烷研究生物样本行政补充：交付样本的资源生成

• 批准号: 10750480
• 负责人: HUGH P. GARAVAN
• 金额: $ 17.54万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10750480
• 关键词: Administrative Supplement; Admission activity; Alcohols; Anxiety; Behavior; Behavioral; Biological; Biology; Brain; Cannabis; Caregivers; Child; Child Development; Child Health; Childhood; Clinical Research; Cognition; Cognitive; Collection; Communities; Complex; Congenital Abnormality; Core Facility; Data Collection; Detection; Development; Discipline of obstetrics; Education; Emergency Medicine; Epigenetic Process; Equipment; Etiology; Evaluation; Exposure to; Family; Fetal Growth; Fetal Reduction; Fetus; Funding; Future; Generations; Genetic; Goals; Gynecology; Health; Healthcare; Heavy Metals; Helping to End Addiction Long-term; Hospitals; Immune; Individual; Infant Development; Infant Health; Infrastructure; Knowledge; Laboratories; Language Delays; Language Development; Link; Longitudinal Studies; Low Birth Weight Infant; Maternal Health; Mediating; Medical center; Memory impairment; Metabolic; Monitor; National Institute of Drug Abuse; Neonatal Abstinence Syndrome; Opioid; Outcome; Parents; Participant; Pathogenicity; Placenta; Policies; Predisposition; Pregnancy; Pregnant Women; Premature Birth; Prenatal care; Prevention; Prevention strategy; Process; Proteins; Protocols documentation; Psychopathology; Research; Research Assistant; Resources; Risk; Sampling; Science; Services; Signaling Protein; Site; Specimen; Tissue Banks; Tissues; Tobacco; Trauma; Umbilical Cord Blood; Umbilical cord structure; United States; Universities; Vermont; adverse outcome; alcohol consumption during pregnancy; electronic medical record system; emotion regulation; fetal; fetal opioid exposure; fetal substance exposure; in utero; inattention; innovation; interest; longitudinal, prospective study; mRNA Expression; maternal opioid use; member; neonatal health; neurodevelopment; neuroimaging; nutrition; opioid use; opioid use disorder; opioid use in pregnancy; polysubstance use; pregnant; prenatal; prenatal exposure; programs; protocol development; racism; response; social; substance use; success; toxicant

PROJECT SUMMARY 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.

项目概要 怀孕期间阿片类药物的使用很普遍，并且与孕妇的不良后果相关 和正在发育的孩子。产前阿片类药物暴露与胎儿和儿童的多种阴性结果有关 结果包括胎儿生长迟缓、早产、出生体重降低、先天缺陷、体重增加 新生儿保健以及后期行为（例如焦虑、注意力不集中）、认知（例如记忆力）的风险增加 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良反应有关 孕产妇、胎儿和儿童的结果、这些结果发生的机制以及潜在的后果 产前阿片类药物暴露对儿童健康和发育（例如大脑和行为）的影响仍然很大 未经探索。缺乏病因学知识导致治疗、预防和缓解工作停滞不前 使个人和家庭容易受到不良后果影响的努力。 健康大脑与儿童发育 (HBCD) 研究是一项 25 个中心的纵向前瞻性研究 美国的早期儿童发展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（例如认知和情绪调节）、体验（例如创伤）、社会（例如 约 7,500 名具有全国代表性的孕妇中的种族歧视）和健康（例如精神病理学）因素 以及他们从怀孕到童年中期的孩子。 HBCD 研究的一个主要目标是增进了解 产前物质暴露的潜在后果。它将丰富母体物质的使用 怀孕期间（即约 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） 怀孕和总样本的 12% 将使用阿片类药物），并提供了一个独特的机会来告知我们 了解与怀孕期间使用阿片类药物相关的不良后果是如何产生的。虽然 六溴环十二烷 (HBCD) 将成为美国最大的早期大脑和儿童发育结果长期研究，其核心 协议不包括交付生物样本的收集。本行政补充回应 NIDA/ORWH 特殊利益行政补充通知：HEAL 倡议：生物样本 妊娠期收集 (NOT-DA-23-005) 建议利用健康的大脑和儿童发育 (HBCD)，扩大核心六溴环十二烷协议的生物样本收集范围，将交付样本包括在内 （胎盘、脐带组织、脐带血）。交付样品将从六溴环十二烷的代表性样品中采集 多达 14 个地点的研究参与者（以及 HBCD 地点超过 2,000 名提交申请的参与者 回应此 NOSI）。这将为更大范围的资源生产提供前所未有的机会 科学界全面评估介导这种联系的病理生理机制 怀孕期间使用阿片类药物和多物质与新生儿、婴儿和/或孕产妇健康不良之间的关系 结果，反过来又为创新的预防策略提供信息。