Cincinnati Outcomes of Babies with Opioid Exposure (OBOE)

摘要 怀孕期间使用阿片类药物是一种全国流行病。产前阿片类药物暴露发生在胎儿大脑快速发育的时期 发展，并可能导致重要的长期结构和功能性神经问题，在暴露 孩子然而，产前阿片类药物暴露的儿童也经常暴露于母亲的心理健康 问题，不良的养育和不利的家庭环境。关键是要确定以下因素的相对影响： 多种不利的暴露对儿童的结果，并确定潜在的可改变的因素。 阿片类药物暴露婴儿结局（OBOE）研究的目的是描述 产前阿片类药物暴露的多方面影响，并确定不良后遗症的可改变风险因素 以优化神经发育、行为和家庭结果。具体目标是：（1）确定 产前阿片类药物暴露对生命头2年大脑结构和连接的影响，（2） 定义暴露于以下物质的婴儿在出生后头2年的医疗、发育和行为结果： 阿片类药物，以及（3）探讨是否以及如何家庭环境，母亲的心理健康，和养育 在生命的头2年改变大脑连接和神经发育的轨迹。 我们假设产前阿片类药物改变了神经连接和神经解剖体积， 暴露，这些变化的幅度与发育和行为结果相关。 此外，家庭和环境因素与产前阿片类药物暴露相互作用，影响轨迹 在生命的头两年里的连接，发展和行为。为了验证这一假设，我们的研究小组 将在一个多中心研究中招募200名阿片类药物暴露的婴儿和75名健康的适当匹配的对照组， 纵向队列研究我们将通过MRI评估脑容量以及结构和功能连接， 2周、6个月和24个月，以及12个月和24个月时的行为和发育。家庭 将在12个月时使用标准化工具对环境进行评估。 我们的联盟由RTI的数据协调中心和四个临床站点组成，所有这些站点都具有 在多中心纵向儿科研究合作方面具有丰富的经验。研究团队成员 在纵向新生儿随访、流行病学、临床试验、健康差异方面具有重要的专业知识， 神经影像学和新生儿阿片类药物戒断综合征（NOWS）。辛辛那提儿童医院的临床研究中心 带来了与NOWS相关的基本研究专业知识，高风险患者纵向随访的经验， 人群，包括阿片类药物暴露的婴儿，神经影像学的创新经验， OBOE联盟在新生儿临床研究中的招募和保留记录，确保 这项重要研究的成功。

ABSTRACT Opioid use during pregnancy is a national epidemic. Prenatal opioid exposure occurs at a time of rapid fetal brain development, and may cause important long-term structural and functional neurologic problems in the exposed child. However, children with prenatal opioid exposure are also often exposed to maternal mental health problems, poor parenting, and adverse home environments. It is critical to determine the relative impacts of multiple adverse exposures on childhood outcomes and identify potentially modifiable factors. The goal of the Outcomes of Babies with Opioid Exposure (OBOE) study is to characterize the multidimensional impact of prenatal opioid exposure and to identify modifiable risk factors for adverse sequelae in order to optimize neurodevelopmental, behavioral, and family outcomes. Specific aims are: (1) To determine the impact of prenatal opioid exposure on brain structure and connectivity over the first 2 years of life, (2) To define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids, and (3) To 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 correlate with developmental and behavioral outcomes. Further, family and environmental factors interact with prenatal opioid exposure to influence the trajectories of connectivity, development, and behavior over the first 2 years of life. To test this hypothesis, our consortium will enroll 200 opioid exposed infants and 75 healthy appropriately matched controls in a multicenter longitudinal cohort study. We will assess brain volumes and structural and functional connectivity by MRI at 2 weeks, 6 months, and 24 months and behavior and development at 12 and 24 months. The home environment will be assessed with a standardized tool at 12 months. Our consortium consists of a Data Coordinating Center at RTI and four Clinical Sites, all of whom have extensive experience collaborating in multicenter longitudinal pediatric research. Study team members have significant expertise in longitudinal neonatal follow-up, epidemiology, clinical trials, health disparities, neuroimaging, and neonatal opioid withdrawal syndrome (NOWS). The Clinical Site at Cincinnati Children’s brings essential research expertise related to NOWS, experience with longitudinal follow-up of high-risk populations including opioid-exposed infants, innovative experience in neuroimaging, and an exceptional track record of recruitment and retention in neonatal clinical research to the OBOE consortium, ensuring success of this important study.