Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

NCT02812095 | Completed DMC

• 1 other identifier: 1407-193-601
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Enterostomy

Outcome Measures

Primary Outcomes (1)

• The change of citrulline level during the study period

  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 Outcomes (4)

• The pathologic findings after refeeding procedure

  up to 8 weeks of corrected age

• the number of days on parenteral nutrition

  up to 8 weeks of corrected age

• The weight gain

  up to 6 months of corrected age

• Adverse events during refeeding procedure

  up to 8 weeks of corrected age

Study Arms (2)

The refeeding group

EXPERIMENTAL

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

Procedure: Refeeding

The control group

NO INTERVENTION

Interventions

Refeeding PROCEDURE

when amount of feeding reach to 120mL/kg a day,

Also known as: extracorporeal stool transport

The refeeding group

Eligibility Criteria

• Age: Up to 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Lee ES, Kim EK, Shin SH, Jung YH, Song IG, Kim YJ, Kim HY, Choi YH, Moon KC, Kim B. Efficacy and safety of mucous fistula refeeding in preterm infants: an exploratory randomized controlled trial. BMC Pediatr. 2023 Mar 29;23(1):137. doi: 10.1186/s12887-023-03950-1.

  PMID: 36991415 DERIVED

MeSH Terms

Interventions

RIFL protein, mouse

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 24, 2016
• Study Start: August 1, 2014
• Primary Completion: December 11, 2019
• Study Completion: April 16, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)