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.

项目总结 怀孕期间阿片类药物的使用很普遍，并与怀孕个体的不良后果有关 和发育中的孩子。产前阿片类药物暴露与广泛的阴性胎儿和儿童相关 结局包括胎儿发育减慢、早产、出生体重降低、先天性缺陷、增加 新生儿保健，以及以后行为(如焦虑、注意力不集中)、认知(如记忆)的高风险 缺陷、语言习得延迟)和新陈代谢问题。尽管阿片类药物的使用与不良反应有关 孕产妇、胎儿和儿童的结局、产生这些后果的机制和潜在的后果 产前阿片类药物暴露对儿童健康和发育(如大脑和行为)的影响在很大程度上仍然存在 未被开发的。这种病因学知识的缺乏导致了治疗、预防和缓解的停滞。 努力使个人和家庭容易受到不良后果的影响。 健康大脑和儿童发展(HBCD)研究是一项25个地点的纵向前瞻性研究 美国早期儿童发展将评估广泛的生物学(例如，神经成像、遗传学、 表观遗传学)、行为(例如认知和情绪调节)、经验(例如创伤)、社会(例如， 在约7,500名具有全国代表性的孕妇中调查了健康(例如，精神病理学)因素 以及他们的孩子从怀孕到童年中期。HBCD研究的一个主要目标是增加对 产前接触物质的潜在后果。它将被丰富用于母体物质使用 在怀孕期间(即，约25%的样本在怀孕期间使用阿片类药物、大麻、酒精和/或烟草 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的 了解与怀孕期间使用阿片类药物相关的不良后果是如何产生的。虽然 HBCD将是美国最大的关于早期大脑和儿童发展结果的长期研究，核心是 议定书不包括收集投放的生物检疫剂。作为回应，本行政副刊 致NIDA/ORWH关于特别利益的行政补编通知：治愈倡议：生物质学 孕期收集(Not-DA-23-005)建议利用大脑和儿童的健康发展 (HBCD)扩大核心HBCD议定书的生物检疫标本收集，将交付标本包括在内 (胎盘、脐带组织、脐带血)。送货样本将从HBCD的代表性样本中收集 多达14个站点的研究参与者(以及提交申请的HBCD站点的超过2,000名参与者 以响应该nosi)。这将为更大的 科学界全面评估调节这种联系的病理生理机制 孕期阿片类药物和多种物质的使用与新生儿、婴儿和/或产妇健康不良之间的关系 结果，并反过来为创新的预防战略提供参考。