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NCT04057820 · ClinicalTrials.gov registry record · NA
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
A NA study, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.
- Completed
- Registry status
- NA
- Development phase
- 1,305
- Enrollment target
NCT04057820: Completed NA study, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.
NCT04057820 is a NA study that has completed, run by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program. The registered enrollment target is 1,305 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04057820, a NA study, has completed, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,305 participants
- Enrollment target
Study Summary
The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.
Primary Outcome
The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density.
Interventions
- OTHER Finnegan Neonatal Abstinence Scoring Tool
- OTHER Eat, Sleep, Console (ESC) care tool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,305 participants |
| Start Date | 2020-09-08 |
| Est. Completion | 2024-09-24 |
| Phase | NA |
What the finished NCT04057820 record still lists
NCT04057820 is an interventional study that assigns participants to a tested intervention. Its 1,305 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Finnegan Neonatal Abstinence Scoring Tool is the first listed.
NCT04057820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04057820 about?
NCT04057820 is a clinical study titled "Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach". The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.
What is the current status of trial NCT04057820?
This trial is currently completed. It is a NA study. The enrollment target is 1,305 participants. The study started on 2020-09-08. Estimated completion is 2024-09-24.
What interventions are being tested in trial NCT04057820?
The interventions under investigation include: Finnegan Neonatal Abstinence Scoring Tool (OTHER), Eat, Sleep, Console (ESC) care tool (OTHER).
Who is sponsoring clinical trial NCT04057820?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04057820's enrollment target sits among peer trials
1,305 76th of 2000 higher than 1,925 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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