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: 10748467
• 负责人: Sara Bonamo DeMauro
• 金额: $ 27.6万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 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/10748467
• 关键词: Administrative Supplement; Alcohols; Anxiety; Behavior; Behavioral; Biological; Biology; Birth; Black, Indigenous, People of Color; Brain; Cannabis; Caregivers; Child; Child Development; Child Health; Childhood; Cognition; Cognitive; Collaborations; Collection; Communities; Complex; Congenital Abnormality; Data Collection; Detection; Development; Education; Ensure; Environment; 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; Joints; 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; Pediatric Hospitals; Pennsylvania; Persons; Philadelphia; Placenta; Policies; Predisposition; Pregnancy; Pregnant Women; Premature Birth; Prenatal care; Prevention; Prevention strategy; Process; Proteins; Protocols documentation; Psychopathology; Research Personnel; Resources; Risk; Sampling; Signaling Protein; Site; Specimen; Tissue Banks; Tissues; Tobacco; Trauma; Umbilical Cord Blood; Umbilical cord structure; United States; Universities; University Hospitals; adverse outcome; alcohol consumption during pregnancy; cohort; 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; obstetric services; opioid use; opioid use disorder; opioid use in pregnancy; polysubstance use; pregnant; prenatal; protocol development; racism; response; social; sociodemographics; study population; substance use; success; toxicant

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.

项目总结/摘要 妊娠期间使用阿片类药物很普遍，并与孕妇和孕妇的不良结局有关。 个人和发展中的孩子。产前阿片类药物暴露与大范围的阴性胎儿相关。 和儿童结果，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 (e.g.,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 不良孕产妇，胎儿和儿童的结果，通过这些机制产生和潜在的 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， 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），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。研究人群将 在怀孕期间为母体物质使用而富集（即，约25%的样本使用过阿片类药物， 怀孕期间吸食大麻、酒精和/或烟草，并且总样本的12%将使用阿片类药物）和 提供了一个独特的机会，让我们了解与之相关的不良后果是如何产生的。 怀孕期间使用阿片类药物的情况有所增加。虽然六溴环十二烷将是对早期大脑和儿童的最大的长期研究， 在美国，核心方案不包括交付生物标本的采集。 本行政补充文件是对NIDA/ORWH特别行政补充通知的回应 兴趣：HEAL倡议：妊娠期生物标本采集（NOT-DA-23-005）建议利用 健康大脑和儿童发育（六溴环十二烷）研究，扩大核心生物样本收集 六溴环十二烷方案包括分娩标本（胎盘、脐带组织和脐带血）。递送 将从多达14个研究中心的六溴环十二烷研究参与者代表性样本中采集样本（以及 六溴环十二烷各生产基地的2，000多名参与者提交了对该国家行动倡议的申请）。这将提供 这是一个前所未有的资源产生机会，使更大的科学界能够全面 评估介导阿片类药物和多种物质使用之间联系的病理生理机制 怀孕期间和不良新生儿，婴儿，儿童和/或孕产妇健康结果，并反过来，通知 创新的预防战略。