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NCT02178189 · ClinicalTrials.gov registry record · Phase 2
RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants
A Phase 2 study of Neonatal Abstinence Syndrome, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT02178189: Completed Phase 2 study of Neonatal Abstinence Syndrome, sponsored by University of Pittsburgh.
NCT02178189 is a Phase 2 study of Neonatal Abstinence Syndrome that has completed, run by University of Pittsburgh. The registered enrollment target is 85 participants, above the 62-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (37% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02178189, a Phase 2 study of Neonatal Abstinence Syndrome, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study Summary
Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes for these high-risk infants. We will conduct a preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and estimates of whether high-calorie formula results in more normal patterns of weight loss and gain, less severe NAS symptoms and shorter hospital stays.
Primary Outcome
Weight loss and gain patterns will include days to return to birth weight, days to weight nadir (lowest point) and maximum percent weight loss.
Conditions Studied
Interventions
- OTHER High Calorie Infant formula
- OTHER Standard Calorie Infant Formula
Study Locations (1)
Pennsylvania
- Magee-Womens Hospital of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT02178189 record still lists
NCT02178189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 62-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (37% higher).
The record links to 1 condition, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 2 interventions - of which High Calorie Infant formula is the first listed.
NCT02178189 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02178189 about?
NCT02178189 is a clinical study titled "RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants". Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes for these high-risk infants. We will conduct a preliminary randomized cl...
What is the current status of trial NCT02178189?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2010-04. Estimated completion is 2013-12.
What conditions does trial NCT02178189 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT02178189?
The interventions under investigation include: High Calorie Infant formula (OTHER), Standard Calorie Infant Formula (OTHER).
Who is sponsoring clinical trial NCT02178189?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02178189 being conducted?
This trial has 1 study location across Pennsylvania. 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 NCT02178189's enrollment target sits among peer trials
85 4th of 17 higher than 14 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
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