RTI International, Research Triangle Park, NC, USA.
Emory University, Atlanta, GA, USA.
Pediatr Res. 2023 May;93(6):1772-1779. doi: 10.1038/s41390-022-02279-2. Epub 2022 Aug 30.
While the health, social, and economic impacts of opioid addiction on adults and their communities are well known, the impact of maternal opioid use on the fetus exposed in utero is less well understood.
This paper presents the protocol of the ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study, a multi-site prospective longitudinal cohort study of infants with antenatal opioid exposure and unexposed controls. Study objectives are to determine the impact of antenatal opioid exposure on brain development and neurodevelopmental outcomes over the first 2 years of life and explore whether family, home, and community factors modify developmental trajectories during this critical time period.
Primary outcomes related to brain development include cortical volumes, deep cerebral gray matter volumes, resting-state functional connectivity measures, and structural connectivity measures using diffusion tensor imaging. Primary neurodevelopmental outcomes include visual abnormalities, cognitive, language, and motor skills measured using the Bayley Scales of Infant Development and social-emotional and behavioral problems and competence measured by the Brief Infant-Toddler Social and Emotional Assessment.
The OBOE study has been designed to overcome challenges of previous studies and will help further understanding of the effects of antenatal opioid exposure on early infant development.
This study will integrate MRI findings and comprehensive neurodevelopmental assessments to provide early insights into the functional topography of the brain in this high-risk population and assess MRI as a potential biomarker. Rather than conducting neuroimaging at a single time point, the study will include serial MRI assessments from birth to 2 years, allowing for the examination of trajectories throughout this period of rapid brain development. While previous studies often have had limited information on exposures, this study will use umbilical cord assays to accurately measure amounts of opioids and other substances from 20 weeks of gestation to birth.
虽然阿片类药物成瘾对成年人及其社区的健康、社会和经济影响众所周知，但母体阿片类药物使用对宫内暴露胎儿的影响了解较少。
本文介绍了 ACT NOW 胎儿暴露于阿片类药物（OBOE）研究的方案，这是一项多地点前瞻性纵向队列研究，研究对象为产前阿片类药物暴露的婴儿和未暴露的对照婴儿。研究目的是确定产前阿片类药物暴露对出生后 2 年内大脑发育和神经发育结果的影响，并探讨家庭、家庭和社区因素是否在此关键时期改变了发育轨迹。
与大脑发育相关的主要结果包括皮质体积、深部脑灰质体积、静息态功能连接测量值以及使用弥散张量成像的结构连接测量值。主要神经发育结果包括使用贝利婴幼儿发展量表测量的视觉异常、认知、语言和运动技能，以及使用简要婴儿-幼儿社会情感评估测量的社会情感和行为问题及能力。
OBOE 研究旨在克服先前研究的挑战，并将有助于进一步了解产前阿片类药物暴露对早期婴儿发育的影响。
该研究将整合 MRI 发现和全面的神经发育评估，为高危人群大脑的功能拓扑结构提供早期见解，并评估 MRI 是否为潜在的生物标志物。该研究将包括从出生到 2 岁的连续 MRI 评估，而不是在单个时间点进行神经影像学检查，从而可以检查整个快速大脑发育期间的轨迹，而以前的研究通常对暴露的信息有限，该研究将使用脐带检测来准确测量从 20 周妊娠到出生期间阿片类药物和其他物质的含量。
