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NCT04149509 · ClinicalTrials.gov registry record

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

A clinical trial of Neonatal Opioid Withdrawal Syndrome, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.

Active
Registry status
300
Enrollment target
6
Study locations

NCT04149509 is a study of Neonatal Opioid Withdrawal Syndrome that is active but no longer recruiting, run by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program. The registered enrollment target is 300 participants, above the 192-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target (56% higher). The trial reports 6 study locations across 5 states.

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The verdict

NCT04149509, a study of Neonatal Opioid Withdrawal Syndrome, is active but no longer recruiting, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.

ACTIVE NOT RECRUITING
Registry status
300 participants
Enrollment target
6
Study locations

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 Studied

Neonatal Opioid Withdrawal Syndrome

Study Locations (6)

Ohio

  • Cincinnati Children's Medical Center - Cincinnati
  • Case Western Reserve University, Rainbow Babies and Children's Hospital - Cleveland

Alabama

  • University of Alabama at Birmingham - Birmingham

District of Columbia

  • Children's National Medical Center - Washington D.C.

North Carolina

  • RTI International - Durham

Pennsylvania

  • Univeristy of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2020-08-19
Est. Completion 2026-12

Sponsor

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

3 total trials

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What the Registry Record Tells You About NCT04149509

The ClinicalTrials.gov registry entry for NCT04149509 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 192-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target (56% higher). The listed sponsor is Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neonatal Opioid Withdrawal Syndrome appearing as the primary indexed condition, and to 0 interventions.

NCT04149509 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Ohio, Alabama, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT04149509 about?

NCT04149509 is a clinical study titled "ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study". 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 a...

What is the current status of trial NCT04149509?

This trial is currently active not recruiting. The enrollment target is 300 participants. The study started on 2020-08-19. Estimated completion is 2026-12.

What conditions does trial NCT04149509 study?

This clinical trial studies the following conditions: Neonatal Opioid Withdrawal Syndrome.

Who is sponsoring clinical trial NCT04149509?

This trial is sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04149509 being conducted?

This trial has 6 study locations across Alabama, District of Columbia, North Carolina, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.