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NCT04419857 · ClinicalTrials.gov registry record · NA
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
A NA study of Neonatal Abstinence Syndrome, sponsored by Yale University.
- Active
- Registry status
- NA
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT04419857: Active NA study of Neonatal Abstinence Syndrome, sponsored by Yale University.
NCT04419857 is a NA study of Neonatal Abstinence Syndrome that is active but no longer recruiting, run by Yale University. The registered enrollment target is 39 participants, below the 64-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04419857, a NA study of Neonatal Abstinence Syndrome, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
Primary Outcome
this will be measured by twice daily weights while in the hospital and once daily weights at home for two weeks after birth compared with birth weight
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT High-calorie formula
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-12-04 |
| Est. Completion | 2026-05 |
| Phase | NA |
What the registry record for NCT04419857 still lists
NCT04419857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 64-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 1 intervention - of which High-calorie formula is the first listed.
NCT04419857 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04419857 about?
NCT04419857 is a clinical study titled "A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants". A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
What is the current status of trial NCT04419857?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 39 participants. The study started on 2020-12-04. Estimated completion is 2026-05.
What conditions does trial NCT04419857 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT04419857?
The interventions under investigation include: High-calorie formula (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04419857?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04419857 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neonatal Abstinence Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04419857's enrollment target sits among peer trials
39 15th of 17 higher than 3 of 17 other Neonatal Abstinence Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neonatal Abstinence Syndrome 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
-
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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