PROJECT SUMMARY/ABSTRACT While the health, social, and economic impacts of opioid addiction on adults are well known, the impact of maternal opioid use on the fetus exposed in utero is less well understood. The Outcomes of Babies with Opioid Exposure (OBOE) Study is an ongoing longitudinal cohort study to prospectively examine the medical, neurodevelopmental, and behavioral outcomes of children who were exposed to opioids in utero as compared with unexposed controls. The objectives of the OBOE Study are to, over the first 2 years of life, (1) determine the impact of antenatal opioid exposure on brain structure and connectivity; (2) define medical, developmental, and behavioral outcomes 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. In response to RFA-HD-24-015, RTI will continue to achieve the following specific aims as the data coordinating center (DCC) for this renewal grant: (1) collaborate with study investigators in developing OBOE protocols and budgets; (2) support OBOE protocol design, training, and implementation; (3) provide data management for the consortium, including programming data management systems and preparing reports for the SSMB, SC, OBOE subcommittees, clinical centers, and NICHD/NIH; (4) provide the neuroimaging expertise for the consortium to help ensure standardization of neuroimaging data acquisition, monitor image acquisition, promote sharing among sites, review and assess images, and provide subject matter expertise for study result analyses; (5) conduct statistical analyses of study data for interim monitoring, final results, and secondary data analyses, and collaborate with study investigators to publish results of OBOE studies in a timely and accurate manner; (6) manage capitation funds, disbursing payments to clinical centers based on enrolled patients and other study milestone triggers, specified in the study protocols and budgets; and (7) provide the logistical support necessary to run an effective and productive consortium. The DCC and four OBOE Clinical Centers have a long history of successful collaboration on completed and ongoing neonatal follow-up studies, including MRI studies and those focused on neonatal opioid withdrawal syndrome. RTI’s approach as the DCC has many innovations such as (1) using an RTI- developed avatar-based Consenter video app to assist with the informed consent process; (2) combining RTI’s extensive data science and statistical expertise with the cutting-edge neuroimaging innovations of Children’s National Medical Center, we will complete one of the first studies on brain structure and connectivity in opioid-exposed infants; (3) integrating analysis of both MRI findings and comprehensive neurodevelopmental assessments; (4) analyzing serial MRI assessments to examine longitudinal trajectories through age 2, and (5) advancing emerging research on social determinants of health and their role in child development.

PROJECT NARRATIVE Limited data are available on the effects of in utero opioid exposure beyond the newborn period. The Outcomes of Babies with Opioid Exposure (OBOE) Study will examine longitudinal advanced MRI imaging and developmental and behavioral outcomes of infants exposed to opioids in utero and unexposed infants from birth to 2 years of age. As the Data Coordinating Center, RTI International will maximize the productivity of the OBOE Study by ensuring rigorous and consistent standards for study design, implementation, data collection, quality assurance, monitoring, and statistical analysis and by providing logistical support for day-to-day functioning and for meetings and conference calls, fostering effective communication, facilitating collaboration, coordinating external services, developing and maintaining a Consortium website, and managing Clinical Center capitation through the implementation of an efficient and accurate payment system.