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.
Study Type
OBSERVATIONAL
Enrollment
250
Pregnant mothers must be taking Buprenorphine or Methadone
Two MRIs : * Second Trimester * Third Trimester
At 1 year of life child will receive a developmental assessment
Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers. At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Alterations in fetal brain volume
Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls
Time frame: Between 20 weeks gestation and delivery
Differences in placenta signal
Comparing differences in placenta signal using MRI between the POE group and controls
Time frame: Between 20 weeks gestation and delivery
Placental epigenetic changes related to POE
Compare placental DNA methylation in POE group and control group
Time frame: Between 20 weeks gestation and delivery
Placental dysfunction biomarkers related to POE
Compare concentrations of blood proteins in POE group vs controls
Time frame: Between 20 weeks gestation and delivery
Neonatal Opioid Withdrawal Syndrome (NOWS) severity
Measuring NOWs severity in the POE group using eat sleep console scores
Time frame: After birth through one year of life
Length of Hospital Stay
Measuring NOWs severity in the POE group using length of hospital stay
Time frame: After birth through one year of life
Ages and Stages Questionnaire Scores during infancy
Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track.
Time frame: After birth through one year of life
Neurocognitive and behavioral development assessment (Bayley-4) at one year of age
Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children.
Time frame: After birth through one year of life
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