Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Seoul National University

Status: Completed

Conditions: Enterostomy

Treatments: Procedure: Refeeding

Study type: Interventional

Funder types: Other

Identifiers

NCT02812095

1407-193-601

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: Under 35 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

The refeeding group

Experimental group

Description:

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

Treatment:

Procedure: Refeeding

The control group

No Intervention group