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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: Active study of Neonatal Opioid Withdrawal Syndrome, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Volumetric analysis will be done with the white matter volume obtained from each of the MRI images collected from birth until 22-24 months of age. The differences between the exposed and non-exposed groups will be calculated.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-08-19 |
| Est. Completion | 2026-12 |
What the registry record for NCT04149509 still lists
NCT04149509 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 192-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target (56% higher).
The record links to 1 condition, with Neonatal Opioid Withdrawal Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT04149509 lists 6 locations in 5 states (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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