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Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)

RecruitingNA

Sponsor: University of Leipzig

Conditions: Enterostomy

Interventions: mucous fistula refeeding

Countries: Austria, Germany, Netherlands

The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.

Eligibility overview

Sex: ALL

Age: — to 12 Months

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Infants \< 366 days,
2. Ileostomy / Jejunostomy,
3. double loop enterostomies and split enterostomies (with mucous fistula)
4. 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. resection of ileocecal valve,
2. colostomy,
3. small bowel atresia,
4. multiple ostomies (more than just an enterostomy and a mucous fistula),
5. chromosomal abnormalities (if known at the time of randomization),
6. Hirschsprung's disease,
7. participation in another drug-intervention study
8. Intestinal perforation due to a hemodynamic heart defect

Locations (17)

Graz, Austria
Vienna, Austria
Tübingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Hanover, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Witten, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Augsburg, Germany
Hamburg, Germany
Marburg, Germany
München, Germany
Amsterdam, Netherlands
Rotterdam, Netherlands