HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium

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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.