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.

项目概要/摘要 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 个人和发育中的儿童。产前阿片类药物暴露与多种胎儿阴性相关 以及儿童结局，包括胎儿生长迟缓、早产、出生体重较低、先天缺陷、 新生儿保健增加，以及后期行为（例如焦虑、注意力不集中）、认知的风险增加 （例如记忆缺陷、语言习得延迟）和代谢问题。尽管阿片类药物的使用存在关联 不良的孕产妇、胎儿和儿童结局、产生这些结局的机制以及潜在的风险 产前阿片类药物暴露对儿童健康和发育（例如大脑和行为）的影响仍然存在 很大程度上尚未探索。病因学知识的缺乏导致了治疗、预防和治疗的停滞。 缓解努力使个人和家庭容易受到不利后果的影响。 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加 了解产前接触物质的潜在后果。研究人群将是 丰富了孕期母体物质使用情况（即约 25% 的样本使用了阿片类药物， 怀孕期间使用大麻、酒精和/或烟草，总样本中的 12% 使用过阿片类药物）和 提供了一个独特的机会让我们了解与 怀孕期间使用阿片类药物会出现。尽管六溴环十二烷将是针对早期大脑和儿童的最大规模的长期研究 就美国的发展成果而言，核心协议不包括交付生物样本的收集。 本行政补充是为了响应 NIDA/ORWH 的特别行政补充通知 兴趣：HEAL Initiative：妊娠期生物样本采集 (NOT-DA-23-005) 建议利用 通过扩大核心生物样本收集进行健康大脑和儿童发育 (HBCD) 研究 六溴环十二烷方案包括分娩标本（胎盘、脐带组织和脐带血）。送货 样品将从多达 14 个地点（以及 HBCD 网站上超过 2,000 名参与者提交了申请以响应此 NOSI）。这将提供 为广大科学界提供前所未有的资源生成机会 评估介导阿片类药物和多物质使用之间联系的病理生理机制 怀孕期间以及不良的新生儿、婴儿、儿童和/或孕产妇健康结果，进而告知 创新的预防策略。