A Prospective Randomized Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 163
- Locations
- 2
- Primary Endpoint
- Time to goal feeds
Study Overview
Brief 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.
Detailed Description
A. SUMMARY AND SPECIFIC AIMS B. RESEARCH DESIGN AND METHODS C. REFERENCES
SUMMARY AND SPECIFIC AIMS
Infantile hypertrophic pyloric stenosis is a condition well known to pediatric surgeons, and has been deemed "the most common cause for surgery in the first 6 months of life". This condition affects a large group of children annually with an incidence of 1.8 per 1000 births. Postoperative length of hospital stay is a financial concern and remains a potential target for reduction in hospital costs. Ultimately, these costs are directly affected by the ability to effectively advance postoperative enteral nutrition. Some experts calculated this savings to be $392.00 per patient while others estimate an impressive $1,290 saved per patient.
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.
The investigators therefore hypothesize that 1) infants provided with an ad lib diet following pyloromotomy will progress more rapidly to full volume feeds than infants provided an incremental advancement in diet, and 2) Preoperative blood chemistry abnormalities will predict increased emesis postoperatively.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 2 Weeks to 10 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects to be included in the study include infants who have a diagnosis of pyloric stenosis who will undergo pyloromyotomy.
Exclusion Criteria
- •Patients with severe underlying medical conditions including but not limited to hypothermia, sepsis, glycemic instability, or need for care in the intensive care unit/neonatal intensive care unit will not be included in the study.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Parent satisfaction measured by satisfaction scale(24 hours to 1 week)
Investigators
Troy Markel
Assistant Professor of Surgery
Indiana University