ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
Running, not enrolling
Conditions studied: Neonatal Opioid Withdrawal Syndrome
In brief
The objective of this longitudinal cohort study is to quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and neurobehavioral outcomes, and explore how specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects
Key facts
- Study ID
- NCT04149509
- Run by
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
- People needed
- 300
- Starts
- 2020-08-19
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-01-29
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Exposed infants: Born ≥37 weeks gestation with second or third trimester opioid exposure
- Control infants: Born ≥37 weeks gestation with no antenatal drug exposure
You may not qualify if…
- Infants with known chromosomal or congenital anomalies potentially affecting the central nervous system
- Apgar score at 5 minutes of <5
- Any requirement for positive pressure ventilation in the NICU
- Inability to return for outpatient MRI and/or follow-up
- IUGR <3rd percentile
- Heavy alcohol use during pregnancy (8+ drinks per week).
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- RTI International — Durham, North Carolina, United States
- Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
- Univeristy of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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