6/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Vanderbilt

6/6 六溴环十二烷产前经历和纵向发展 (PRELUDE) 联盟范德比尔特

• 批准号: 10748148
• 负责人: Laurie E Cutting
• 金额: $ 31.74万
• 依托单位: VANDERBILT UNIVERSITY
• 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/10748148
• 关键词: Administrative Supplement; Alcohols; Anxiety; Behavior; Behavioral; Biological; Biology; Brain; Cannabis; Caregivers; Child; Child Development; Child Health; Childhood; Cognition; Cognitive; Collaborations; Collection; Communities; Complex; Congenital Abnormality; Data Collection; Detection; Development; Education; Epigenetic Process; Etiology; Evaluation; Exposure to; Family; Fetal Growth; Fetal Reduction; Fetus; Funding; Future; Generations; Genetic; Goals; Health; Healthcare; Heavy Metals; Helping to End Addiction Long-term; Immune; Individual; Infant Health; Infrastructure; Knowledge; Language Delays; Language Development; Link; Longitudinal Studies; Low Birth Weight Infant; Maternal Health; Mediating; Memory impairment; Metabolic; 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 Support; Resources; Risk; Sampling; Signaling Protein; Site; Specimen; Tissue Banks; Tissues; Tobacco; Trauma; Umbilical Cord Blood; Umbilical cord structure; United States; United States National Institutes of Health; adverse outcome; alcohol consumption during pregnancy; emotion regulation; fetal; fetal opioid exposure; fetal substance exposure; in utero; inattention; innovation; interest; longitudinal, prospective study; mRNA Expression; maternal opioid use; neonatal health; neurodevelopment; neuroimaging; nutrition; opioid use; opioid use disorder; opioid use in pregnancy; patients who use opioids; polysubstance use; pregnant; prenatal; prenatal experience; protocol development; racism; response; social; substance use; success; toxicant

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.

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 和发育中的孩子。产前阿片类药物暴露与广泛的阴性胎儿和儿童相关 结果包括胎儿生长减慢、早产、出生体重降低、先天性缺陷、 新生儿保健，以及后期行为的风险增加（例如，焦虑，注意力不集中），认知（例如，存储器 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，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。 健康大脑和儿童发育（HBCD）研究是一项25个研究中心的纵向前瞻性研究， 在美国的儿童发展，将评估广泛的生物（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），经验的（例如，创伤），社会（例如， 种族主义）和健康（例如，精神病理学）因素在约7，500名全国代表性孕妇中进行了研究 和他们的孩子从怀孕到童年中期。六溴环十二烷研究的一个主要目标是增加 了解产前物质暴露的潜在后果。它将丰富产妇 怀孕期间使用的物质（即，约25%的样本将使用阿片类药物、大麻、酒精和/或 怀孕期间吸烟和总样本的12%将使用阿片类药物），并提供了一个独特的机会， 告知我们对妊娠期间使用阿片类药物相关不良后果的理解 起来。虽然六溴环十二烷将是世界上最大的早期大脑和儿童发育结果长期研究， 在美国，核心方案不包括交付生物标本的采集。本行政补充文件 回应NIDA/ORWH行政补充特别利益通知：HEAL倡议： 妊娠期生物标本采集（NOT-DA-23-005）建议利用健康的大脑和儿童 通过扩大六溴环十二烷核心议定书的生物标本收集以包括交付， 样本（胎盘、脐带组织、脐带血）。将从代表性样品中收集交付样品 六溴环十二烷研究参与者在多达14个研究中心的人数（以及六溴环十二烷研究中心的2，000多名参与者提交了 （针对此NOSI的应用）。这将提供前所未有的资源产生机会， 一个更大的科学界，以全面评估病理生理机制，介导 妊娠期间使用阿片类药物和多种物质与新生儿、婴儿和/或 孕产妇保健成果，并反过来为创新的预防战略提供信息。