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性的流行病。产前阿片类药物暴露发生在快速胎儿时期 大脑发育，并可能导致重要的长期结构和功能的神经问题 暴露的孩子。然而，产前接触阿片类药物的儿童也经常暴露于母亲的心理 健康问题，糟糕的父母教养，以及不利的家庭环境。关键是要确定相对的 多次不良暴露对儿童结局的影响，并确定潜在的可改变因素。 有阿片类药物暴露的婴儿结局研究的目标是描述 产前阿片类药物暴露的多维影响和确定不良后遗症的可改变的危险因素 以优化神经发育、行为和家庭结果。具体目标是：(1)确定 出生前两年接触阿片类药物对大脑结构和连接的影响，(2)至 确定婴儿在出生后头两年内的医学、发育和行为结果 阿片类药物，以及(3)探索家庭环境、母亲心理健康和育儿方式是否以及如何 修改出生后头两年的大脑连通性和神经发育轨迹。 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。 这些变化的大小与发育和行为有关 结果。此外，家庭和环境因素与产前阿片类药物接触相互作用，影响 在生命的头两年，连接、发展和行为的轨迹。为了检验这一假设， 我们的联合体将招募200名接触阿片类药物的婴儿和75名健康的适当匹配的对照组 多中心纵向队列研究。我们将评估大脑体积、结构和功能 2周、6个月和24个月时的MRI连接性以及12和24个月时的行为和发育 月份。12个月后，将使用标准化工具对家庭环境进行评估。 我们的联盟由RTI的一个数据协调中心和四个临床站点组成，这些站点都有 在多中心纵向儿科研究方面有丰富的合作经验。学习团队成员 在新生儿纵向随访、流行病学、临床试验、健康方面拥有丰富的专业知识 差异、神经成像和NOWS。位于CHOP/Penn的临床网站提供了以下方面的基本专业知识 对高危人群的纵向跟踪，因果推断等先进的统计方法， 婴儿和学步儿童的系列神经成像，以及招募和保留儿童的特殊记录 将新生儿临床研究交给双子座联盟，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 NOWS. The Clinical Site at CHOP/PENN brings essential expertise in longitudinal follow-up of high-risk populations, advanced statistical methods such as causal inference, serial neuroimaging in infants and toddlers, and exceptional track records of recruitment and retention in neonatal clinical research to the OBOE consortium, ensuring success of this important study.