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.

项目摘要/摘要 怀孕期间的阿片类药物使用普遍存在，并与怀孕的不良结局有关 个人和发育中的孩子。产前阿片类药物暴露与广泛的负胎儿有关 以及儿童结局，包括胎儿生长减少，早产，降低出生体重，先天性缺陷， 新生儿医疗保健增加，并增加了以后行为的风险（例如焦虑，注意力不集中），认知 （例如，记忆缺陷，延迟语言获取）和代谢问题。尽管使用阿片类药物链接 为了不利的母亲，胎儿和儿童的结果，这些产生的机制和潜力 产前阿片类药物暴露对儿童健康和发育的后果（例如，大脑和行为）仍然存在 在很大程度上没有探索。缺乏病因学知识导致了停滞的治疗，预防和 缓解工作使个人和家庭容易回避不良后果。 健康的大脑和儿童发育（HBCD）研究是一项25个地点的纵向前瞻性研究 美国的早期儿童发育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（例如认知和情感调节），经验性（例如创伤），社会（例如， 种族主义）和健康（例如，心理病理学）因素，约有7,500名全国代表性的孕妇 以及他们的孩子从怀孕到儿童中期。 HBCD研究的主要目标是增加 了解产前物质暴露的潜在后果。研究人群将是 在怀孕期间富含产妇使用物质（即约25％的样本将使用阿片类药物， 怀孕期间大麻，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来告知我们对与不利后果如何相关的理解 怀孕期间使用阿片类药物。尽管HBCD将是早期大脑和儿童的最大长期研究 在美国的发展结果，核心方案不包括递送生物测量的收集。 此行政补充，以响应NIDA/ORWH的管理补充通知 兴趣：Heal Initiative：怀孕的生物体质收集（NOT-DA-23-005）提议利用 健康的大脑和儿童发育（HBCD）研究通过扩大核心的生物循环收集 HBCD方案包括输送样品（胎盘，脐带组织和脐带血）。送货 将从多达14个地点的HBCD研究参与者的代表性样本中收集样本（和 HBCD网站上有超过2,000名参与者根据该NOSI提交申请）。这将提供 较大的科学界是一个前所未有的资源生成的机会 评估介导阿片类药物与多核酸固定使用之间联系的病理生理机制 在怀孕期间和不良新生儿，婴儿，儿童和/或孕产妇的健康状况，进而告知 创新的预防策略。