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.

项目摘要 怀孕期间的阿片类药物使用普遍存在，并与怀孕个人的不良后果有关 和发育中的孩子。产前阿片类药物暴露与广泛的负胎儿和儿童有关 结局包括减少胎儿生长，早产，减少出生体重，先天性缺陷，增加 新生儿医疗保健以及后来行为的风险增加（例如焦虑，注意力不集中），认知（例如记忆 缺陷，语言获取延迟）和代谢问题。尽管使用阿片类药物链接到不利 孕产妇，胎儿和儿童结果，这些产生的机制以及潜在的后果 儿童健康与发育产前阿片类药物暴露（例如，大脑和行为）仍然很大程度上仍然存在 未探索。缺乏病因学知识导致了停滞的治疗，预防和缓解措施 努力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理解 产前物质暴露的潜在后果。它将丰富用于母体使用物 在怀孕期间（即约25％的样本将使用阿片类药物，大麻，酒精和/或烟草在期间使用 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 了解在怀孕期间与阿片类药物使用相关的不良后果如何出现。虽然 HBCD将是美国早期大脑和儿童发育结果的最大长期研究，核心 协议不包括递送生物测量的收集。这种行政补充回应 转到NIDA/ORWH的管理补充特殊利益通知：Heal Initiative：BiosPecimen 怀孕的收集（非DA-23-005）提议利用健康的大脑和儿童发展 （HBCD）通过扩展核心HBCD协议的生物测量集合以包括输送样品 （胎盘，脐带组织，脐带血）。将从HBCD的代表性样本中收集输送样品 研究参与者多达14个站点（以及HBCD网站的2,000多名参与者提交申请 响应这种NOSI）。这将为更大的资源提供前所未有的资源创造机会 科学界全面评估介导联系的病理生理机制 在怀孕期间的阿片类药物和多物质使用以及不良的新生儿，婴儿和/或孕产妇健康之间 结果又为创新的预防策略提供了信息。