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Clinical Trial Summary

The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are: - Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment. - To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment. In this study participants will: - Receive two placental-fetal MRIs, one during second trimester and one in third trimester. - Answer surveys relating to their medical and social history. - Have blood drawn during pregnancy and delivery. - Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06415994
Study type Observational
Source Indiana University
Contact
Status Enrolling by invitation
Phase
Start date February 13, 2024
Completion date December 1, 2029

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