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

NCT04149509 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-01-29

No results posted yet for this study

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

Conditions

  • Neonatal Opioid Withdrawal Syndrome

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

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

    lead NETWORK

Principal Investigators

  • Carla Bann, PhD · RTI International

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149509 on ClinicalTrials.gov