Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

March 16, 2021 updated by: Ee-Kyung Kim, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The control group
Experimental: The refeeding group
Refeeding is initiated when 120mL/kg/day of enteral feed reaches or stoma loss exceeds more than 40ml/kg/day after operation.
when amount of feeding reach to 120mL/kg a day,
Other Names:
  • extracorporeal stool transport

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of citrulline level during the study period
Time Frame: 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
up to 6 months of corrected age

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 11, 2019

Study Completion (Actual)

April 16, 2020

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1407-193-601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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