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Search / Trial NCT03469609

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

Launched by UNIVERSITY OF LEIPZIG · Mar 16, 2018

Trial Information

Current as of May 01, 2025

Recruiting

Keywords

Infants Necrotizing Enterocolitis (Nec) Focal Intestinal Perforation (Fip) Enterostomy Creation Bowel Reanastomosis Enteral Feeding Caloric Intake Parenteral Nutrition Complication Rate Reduction Of Hospital Expenses Length Of Hospital Stay Refeeding

ClinConnect Summary

The MUC-FIRE trial is studying a new way to help babies and young children with a type of surgical opening in their intestines, called an enterostomy. This trial is looking at whether feeding a small amount of food through a related opening, known as a mucous fistula, can help these children start eating normally faster after their surgery to close the enterostomy. This method is compared to the standard care currently provided.

To participate in this study, eligible children include infants under one year old who have had specific types of intestinal surgeries, such as ileostomy or jejunostomy. Parents or legal guardians must be willing to provide consent and follow the treatment plan. If your child is accepted into the trial, they will receive close monitoring and support during the feeding process. This study aims to improve the recovery experience for families by potentially shortening the time it takes for their child to return to a regular diet after surgery.

Gender

ALL

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

About University Of Leipzig

The University of Leipzig is a renowned academic institution in Germany, recognized for its commitment to advancing medical research and education. With a strong emphasis on interdisciplinary collaboration, the university fosters innovative clinical trials that aim to enhance patient care and contribute to the understanding of various health conditions. Its research initiatives are supported by state-of-the-art facilities and a diverse team of experts, positioning the University of Leipzig as a leader in the field of clinical research and a vital contributor to the global medical community.

Locations

Wien, , Austria

Rotterdam, , Netherlands

Leipzig, Sachsen, Germany

Tübingen, Baden Württemberg, Germany

Graz, , Austria

München, Bayern, Germany

Frankfurt, Hessen, Germany

Hannover, Niedersachsen, Germany

Hannover, Niedersachsen, Germany

Mainz, Rheinland Pfalz, Germany

Dresden, Sachsen, Germany

Augsburg, , Germany

Hamburg, , Germany

Marburg, , Germany

Amsterdam, , Netherlands

Witten, Nordrhein Westfalen, Germany

Patients applied

0 patients applied

Trial Officials

Omid Madadi-Sanjani, Dr. med.

Principal Investigator

Hannover Medical School, Department of Pediatric Surgery

Martin Lacher, Prof. Dr.

Principal Investigator

University of Leipzig, Department of Pediatric Surgery

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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