Who is sponsoring NCT02415049?

NCT02415049 is sponsored by Indiana University.

What drugs are being tested in NCT02415049?

Interventions in NCT02415049: Incremental Feeds, Ad lib feeds.

What condition does NCT02415049 study?

NCT02415049 studies Postoperative Feeding Following Pyloromyotomy.

Is NCT02415049 still recruiting?

NCT02415049 is currently completed. Last updated 12 May 2016.

Last reviewed 2016-05-12 · How we verify

NCT02415049

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Prospective Randomized Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy

Completed NA Last updated 12 May 2016

What this trial tests

NA trial testing Incremental Feeds in Postoperative Feeding Following Pyloromyotomy in 163 participants. Completed in 1 September 2015.

Timeline

1 January 2014

Primary endpoint
1 September 2015

1 September 2015

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	163
Start date	1 January 2014
Primary completion	1 September 2015
Estimated completion	1 September 2015
Sites	1 location across United States

Drugs / interventions tested

Incremental Feeds
Ad lib feeds

Conditions studied

Postoperative Feeding Following Pyloromyotomy — all drugs for Postoperative Feeding Following Pyloromyotomy →

Sponsor

Indiana University

Who can join

Adults 2 Weeks to 10 Weeks, any sex, with Postoperative Feeding Following Pyloromyotomy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Time to goal feeds
Time frame: 24-48 hours
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)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02415049 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 12 May 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02415049.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing