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ACTIVE NOT RECRUITING
NCT04149509

ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study

Sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

Any - 1 Month

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2020-08-19

Completion Date

2026-12

Last Updated

2025-01-29

Healthy Volunteers

Yes

Locations (6)

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