Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Not Applicable

Completed

• Conditions: Enterostomy
• Interventions: Procedure: Refeeding

• Registration Number: NCT02812095
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the efficacy and safety of the practice of refeeding in preterm infants with enterostomy. Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other laboratory findings will be collected. Serial citrulline levels during refeeding procedure and pathologic specimens of bowel (at the time of stoma closure) will be collected for evaluating bowel adaptation.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-24
• Primary Completion: 2019-12-11
• Study Completion: 2020-04-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy

Exclusion Criteria

• Congenital gastrointestinal malformation
• Blind pouch (after laparotomy)
• Refeeding procedure related infection
• Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
The refeeding group	Refeeding	Refeeding is initiated when 120mL/kg/day of enteral feed reaches or stoma loss exceeds more than 40ml/kg/day after operation.

Primary Outcome Measures

Name	Time	Method
The change of citrulline level during the study period	up to 6 months of corrected age	4 time points: at the time of full enteral feeding (\>120 cc/kg/day), 4 weeks later after full enteral feeding, at the time of stoma closure operation, 12 weeks later after closure operation

Secondary Outcome Measures

Name	Time	Method
The pathologic findings after refeeding procedure	up to 8 weeks of corrected age	villus height, crypt depth, mucosal thickening of pathologic specimens at the time of stoma closure operation
the number of days on parenteral nutrition	up to 8 weeks of corrected age	the day of discontinuation of intravenous protein supplements
The weight gain	up to 6 months of corrected age	differences in the admission weight Z-scores and end of study weight Z-scores
Adverse events during refeeding procedure	up to 8 weeks of corrected age	bowel prolapse, enteral hemorrhage, abdominal distension, infection related stoma

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of