HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium

HEAL 计划：产前阿片类药物暴露纵向研究联盟

• 批准号: 9901874
• 负责人: CARLA M BANN
• 金额: $ 1101.84万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9901874
• 关键词: 2 year old; Achievement; Adult; Affect; Alabama; Amygdaloid structure; Behavior; Behavioral; Biological; Biological Assay; Brain; Caregivers; Cerebrum; Child; Child Rearing; Clinical Trials; Cognitive; Collaborations; Communities; Data; Data Coordinating Center; Development; Diffusion Magnetic Resonance Imaging; Dose; Emotional; Enrollment; Ensure; Environment; Environmental Risk Factor; Epidemic; Epidemiology; Equipment and supply inventories; Evaluation; Exposure to; Family; Fetus; Follow-Up Studies; Funding; Future; Goals; Head circumference; Health; Home environment; Image; Infant; Informed Consent; International; Intervention Trial; Language; Life; Literature; Longitudinal Studies; Longitudinal cohort study; Magnetic Resonance Imaging; Measures; Mediating; Medical; Medical center; Mental Depression; Mental Health; Motor; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatal Abstinence Syndrome; Newborn Infant; Opiate Addiction; Opioid; Outcome; Participant; Pediatric Hospitals; Pediatric Research; Pennsylvania; Performance; Pregnancy; Problem behavior; Process; Psychotropic Drugs; Recording of previous events; Research Support; Rest; Risk Factors; Schools; Severities; Social Impacts; Stress; Structure; Symptoms; Tablets; Testing; Time; Toddler; Umbilical cord structure; United States; Universities; Vulnerable Populations; antenatal; base; behavioral outcome; birth control; brain volume; clinical research site; connectome; design; economic impact; experience; fetal; fetal opioid exposure; follow-up; gray matter; health disparity; high risk; high risk population; imaging modality; improved outcome; in utero; indexing; infant outcome; innovation; maternal opioid use; maternal stress; member; modifiable risk; multimodality; neurobehavioral; neurodevelopment; neuroimaging; opioid exposure; opioid misuse; opioid use; opioid withdrawal; postnatal; prenatal exposure; prospective; relating to nervous system; response; social; white matter

PROJECT SUMMARY/ABSTRACT While the health, social, and economic impacts of opioid addiction on adults and their communities are well known, the impact of maternal opioid use and misuse on the fetus exposed in utero is less well understood. The Outcomes of Babies with Opioid Exposure (OBOE) Study is a longitudinal cohort study to prospectively examine the medical, neuroanatomical, neurodevelopmental, behavioral, and social/family/home outcomes of children who were exposed to opioids in utero as compared with matched controls. The objectives of the OBOE Study are to (1) determine the impact of antenatal opioid exposure on brain structure and connectivity over the first 2 years of life; (2) define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids; and (3) explore whether and how the home environment, maternal mental health, and parenting modify trajectories of brain connectivity and neurodevelopment over the first 2 years of life. We hypothesize that neural connectivity and neuroanatomical volumes are altered by prenatal opioid exposure and that the magnitude of these alterations correlates with developmental and behavioral outcomes. Further, maternal and environmental factors interact with prenatal opioid exposure to influence the trajectories of connectivity, development, and behavior over the first 2 years of life. The OBOE Study Consortium includes four Clinical Sites (Case Western University, Children's Hospital of Pennsylvania, Cincinnati Children's Hospital Medical Center, and the University of Alabama at Birmingham) and an independent Data Coordinating Center (DCC) at RTI International, comprising an Administrative Core and a Research Support Core. The Consortium also includes a neuroimaging core at the Children's National Medical Center, which has an extensive track record of studying brain development in healthy and high-risk fetuses, newborns, and infants using advanced, serial, multimodal MR imaging methods. The DCC and Clinical Sites have a long history of successful collaborations on past and ongoing multisite neonatal follow-up studies, including the NICHD-funded Neonatal Research Network. The proposed study has many innovations including (1) optimizing efficiencies by leveraging ongoing collaborations; (2) integrating both MRI and neurodevelopmental data to obtain a multidimensional evaluation of outcomes; (3) conducting serial MRI assessments to examine trajectories of brain development within the first 2 years of life; (4) using umbilical cord assays to accurately measure amounts of opioid and other substance exposure, which will allow us to examine dose-response effects; and (5) using an innovative tablet application developed by the DCC that will assist with the informed consent process to facilitate participant understanding among this high-risk population.

项目总结/摘要 虽然阿片类药物成瘾对成年人及其社区的健康，社会和经济影响很好， 虽然已知母体使用和滥用阿片类药物对子宫内暴露的胎儿的影响，但人们对这一影响的了解较少。 阿片类药物暴露婴儿结局（OBOE）研究是一项前瞻性纵向队列研究， 检查医学、神经解剖学、神经发育、行为和社会/家庭/家庭结果 与对照组相比，子宫内暴露于阿片类药物的儿童。的目标 OBOE研究旨在（1）确定产前阿片类药物暴露对大脑结构的影响， 在生命的前2年的连接;（2）定义医疗，发展和行为结果 在前2年的生活中暴露于阿片类药物的婴儿;和（3）探讨是否以及如何家庭 环境、母亲的心理健康和养育方式改变了大脑连接的轨迹， 在生命的前两年，神经发育。我们假设神经连接和 神经解剖学体积被产前阿片类药物暴露改变， 改变与发育和行为结果相关。此外，产妇和环境 因素与产前阿片类药物暴露相互作用，影响连接，发展和 在生命的前两年的行为。OBOE研究联盟包括四个临床研究中心（病例 西部大学、宾夕法尼亚儿童医院、辛辛那提儿童医院医疗中心，以及 位于伯明翰的亚拉巴马大学）和位于RTI的独立数据协调中心（DCC 国际，包括一个行政核心和一个研究支助核心。该财团还 包括儿童国家医疗中心的神经成像核心，该中心有着广泛的跟踪记录 研究健康和高危胎儿，新生儿和婴儿的大脑发育， 系列、多模式MR成像方法。DCC和临床研究中心有着悠久的成功历史， 过去和正在进行的多中心新生儿随访研究的合作，包括NICHD资助的 新生儿研究网络。本研究具有以下创新性：（1）优化效率 通过利用正在进行的合作;（2）整合MRI和神经发育数据， 结果的多维评价;（3）进行系列MRI评估，以检查 在生命的头2年内的大脑发育;（4）使用脐带测定准确测量 阿片类药物和其他物质的暴露量，这将使我们能够检查剂量反应效应;以及 (5)使用DCC开发的创新平板电脑应用程序，该应用程序将有助于知情同意 这一过程有助于参与者了解这一高风险人群。