Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Enterostomy Clinical Trial

Official title:

Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812095
• Other study ID #: 1407-193-601
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: April 16, 2020

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 16, 2020
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 35 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Enterostomy

Intervention

Procedure:
• Refeeding
when amount of feeding reach to 120mL/kg a day,

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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