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: 10414223
• 负责人: CARLA M BANN
• 金额: $ 175万
• 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/10414223
• 关键词: 2 year old; Address; Administrative Supplement; Birth; Brain; Cellular Phone; Child Rearing; Development; Enrollment; Exposure to; Family; Funding; Goals; Helping to End Addiction Long-term; Home environment; Image; Infant; Life; Living Arrangement; Logistics; Longitudinal Studies; Longitudinal cohort study; MRI Scans; Magnetic Resonance Imaging; Medical; Mental Health; Opioid; Outcome; Performance; Process; Research Personnel; Sample Size; Services; Structure; Target Populations; Time; Transportation; antenatal; behavioral outcome; birth control; food insecurity; neurodevelopment; opioid exposure; sleep difficulty

PROJECT SUMMARY/ABSTRACT The ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study is a longitudinal cohort study examining neurodevelopmental and behavioral outcomes from birth to 2 years of age among infants with antenatal opioid exposure compared to controls. The objectives of the ACT NOW 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. In the process of implementing this groundbreaking study, the investigators have identified significant logistical challenges to study participation faced by families in the target population, including high levels of food insecurity, substantial mobility in living arrangements, and difficulty with affording transportation, childcare, and cell phone service. In addition, greater than expected sleeping difficulties have been encountered among infants, which impacts the performance of the unsedated MRI scans included in the study. This administrative supplement will provide support to address these challenges, enabling successful completion of the OBOE study with the targeted sample size. Specifically, the goals of this administrative supplement to the ACT NOW OBOE study are to (1) address logistical challenges to study enrollment and participation; and (2) increase study coordinator and MRI scan time to allow for successful completion of MRI scans of infants throughout the first 2 years of life.

项目摘要/摘要 ACT Now对婴儿阿片类药物暴露的结果(双簧管)研究是一项纵向队列研究 检查婴儿从出生到2岁的神经发育和行为结果 产前阿片类药物暴露与对照组的比较。ACT NOW双簧管研究的目标是(1) 确定产前阿片类药物暴露对前两年大脑结构和连接性的影响 生命年限；(2)定义生命的头两年的医疗、发育和行为结果 婴儿接触阿片类药物；以及(3)探索家庭环境、母亲心理是否以及如何 健康状况和养育方式改变了前两个阶段的大脑连通性和神经发育轨迹 生命中的岁月。在实施这项开创性研究的过程中，调查人员发现 研究目标人群中家庭的参与度面临的重大后勤挑战，包括 粮食不安全程度、生活安排的流动性大以及难以负担 交通、育儿和手机服务。此外，睡眠困难也比预期的要大 在婴儿中遇到过，这影响了包括在 这项研究。本行政副刊将为应对这些挑战提供支持，使 顺利完成目标样本量的双簧管研究。具体地说，这一目标是 ACT NOW双簧管研究的行政补充是：(1)解决需要研究的后勤挑战 登记和参与；以及(2)增加研究协调员和MRI扫描时间，以确保成功 完成婴儿出生后头两年的核磁共振扫描。