ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study (NCT04149509)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (7 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: Not specified to 1 Month
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Children's National Medical Center — Washington D.C., District of Columbia
- RTI International — Durham, North Carolina
- Cincinnati Children's Medical Center — Cincinnati, Ohio
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio
- Univeristy of Pennsylvania — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neonatal Opioid Withdrawal Syndrome
- MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome — Hershey, Pennsylvania
- Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome — Birmingham, Alabama
- Neurostimulation to Improve NOWS Outcomes — Charleston, South Carolina
- Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) — Birmingham, Alabama
Explore by condition: All Neonatal Opioid Withdrawal Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.