A randomized multicenter open-label controlled trial to show that mucous fistula refeeding reduces the time from enterostomy closure to full enteral feeds (MUCous FIstula REfeeding (*MUC-FIRE*) trial)

• Conditions: Enterostomy; mucous fistula refeeding

• Registration Number: NL-OMON56093
• Lead Sponsor: niversity of Leipzig, Department of Pediatric Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1. Only infants younger than 366 days of age with status post ileostomy or
jejunostomy creation (double loop enterostomies and split enterostomies (with
mucous fistula)) will be included in the study to create a homogenous cohort of
patients with similar diseases (e.g. necrotizing enterocolitis [NEC], focal
intestinal perforation [FIP]). Also, infants of this age group are unique in
several respects such as the response to parenteral nutrition and its hepatic
toxicity resulting into neonatal cholestasis. The ostomy localization is
restricted to the jejunum and ileum. Therefore, the cohort of
patients shows a similar bowel length for fluid-, vitamin- and electrolyte
resorption.
2. All patients with meconium ileus are included into the study. If later
(required) diagnostics verify cystic fibrosis, the diagnostics as well as the
diagnosis need to be documented in the eCRF and in further analysis subgroups
will be established.
3. Signed written informed consent obtained by parents/legal guardians and
willingness
of parents/legal guardians to comply with treatment and follow-up procedures of
their
child.

Exclusion Criteria

1. The resection of the ileocecal valve is an exclusion criterion because of
its association
with extensive bowel resection and therefore prolonged parenteral nutrition
[10].
2. Colostomy.
3. Patients with small bowel atresia are excluded because of prenatally
underdeveloped
bowel distal to the atresia.
4. Multiple ostomies (more than just an enterostomy and a mucous fistula).
5. Patients with chromosomal abnormalities (if known at the time of
randomization) are
excluded because of potential malabsorption and malnutrition due to an
underlying
syndrome.
6. Hirschsprung disease secondary exclusion.
7. Participation in another drug-intervention study.
8. Intestinal perforation due to congenital heart defects with impaired
hemodynamics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified