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NCT02415049 · ClinicalTrials.gov registry record · NA
A Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 163
- Enrollment target
NCT02415049: Completed NA study, sponsored by Indiana University.
NCT02415049 is a NA study that has completed, run by Indiana University. The registered enrollment target is 163 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02415049, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 163 participants
- Enrollment target
Study Summary
There are several choices to consider when determining the timing of initiation of enteral feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as the infant awakens from anesthesia. Some authors have suggested a period of withholding feedings for several hours postoperatively, while others have recommended a significantly longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises over whether a physician chooses a standardized, incremental feeding regimen versus an ad libitum feeding schedule which allows the infant to decide when and how much to eat. Neither has been studied effectively in a randomized controlled setting. A recent review of the literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be the best postoperative regimen. This however, has not been studied in a randomized, controlled trial.
Primary Outcome
We are measuring the time it takes for the child to reach goal feeds following surgery. (100ml/kg/day in incremental group, or 12.5ml/kg/feed in ad lib group)
Interventions
- OTHER Incremental Feeds
- OTHER Ad lib feeds
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT02415049 record still lists
NCT02415049 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Incremental Feeds is the first listed.
NCT02415049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02415049 about?
NCT02415049 is a clinical study titled "A Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy". There are several choices to consider when determining the timing of initiation of enteral feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as the infant awakens from anesthesia. Some authors have suggested a period of withholding feedings for several hours pos...
What is the current status of trial NCT02415049?
This trial is currently completed. It is a NA study. The enrollment target is 163 participants. The study started on 2014-01. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02415049?
The interventions under investigation include: Incremental Feeds (OTHER), Ad lib feeds (OTHER).
Who is sponsoring clinical trial NCT02415049?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02415049's enrollment target sits among peer trials
163 627th of 2000 higher than 1,374 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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