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A Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy

NCT02415049 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2016-05-13

No results posted yet for this 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.

Conditions

  • Postoperative Feeding Following Pyloromyotomy

Interventions

OTHER

Incremental Feeds

This arm of patients will be fed in the traditional standard of care manner following pyloromyotomy. They start with 15ml of pedialyte and advance by 15ml increments of formula or breastmilk to a goal of 100ml/kg/day

OTHER

Ad lib feeds

This arm of patients will be fed ad lib following pyloromyotomy. They will be allowed to eat as frequently as they desire based on infant cues to a goal of 12.5ml/kg/feed

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02415049 on ClinicalTrials.gov