TY  - JOUR
A1  - Großhennig, Anika
A1  - Wiesner, Sören
A1  - Hellfritsch, Juliane
A1  - Thome, Ulrich
A1  - Knüpfer, Matthias
A1  - Peter, Corinna
A1  - Metzelder, Martin
A1  - Binder, Christoph
A1  - Wanz, Ulrike
A1  - Flucher, Christina
A1  - Brands, Björn O.
A1  - Mollweide, Andreas
A1  - Ludwikowski, Barbara
A1  - Koluch, Anna
A1  - Scherer, Simon
A1  - Gille, Christian
A1  - Theilen, Till-Martin
A1  - Rochwalsky, Ulrich
A1  - Karpinski, Christian
A1  - Schulze, Annekatrin
A1  - Schuster, Tobias
A1  - Weber, Florian
A1  - Seitz, Guido
A1  - Gesche, Jens
A1  - Nissen, Matthias
A1  - Jäger, Maximilian
A1  - Koch, Armin
A1  - Ure, Benno
A1  - Madadi-Sanjani, Omid
A1  - Lacher, Martin
T1  - MUC-FIRE: study protocol for a randomized multicenter open-label controlled trial to show that MUCous FIstula REfeeding reduces the time from enterostomy closure to full enteral feeds
T2  - Contemporary Clinical Trials Communications
N2  - Background

After enterostomy creation, the distal bowel to the ostomy is excluded from the physiologic passage of stool, nutrient uptake, and growth of this intestinal section. Those infants frequently require long-term parenteral nutrition, continued after enterostomy reversal due to the notable diameter discrepancy of the proximal and distal bowel. Previous studies have shown that mucous fistula refeeding (MFR) results in faster weight gain in infants. The aim of the randomized multicenter open-label controlled MUCous FIstula REfeeding (“MUC-FIRE”) trial is to demonstrate that MFR between enterostomy creation and reversal reduces the time to full enteral feeds after enterostomy closure compared to controls, resulting in shorter hospital stay and less adverse effects of parenteral nutrition.

Methods/Design: A total of 120 infants will be included in the MUC-FIRE trial. Following enterostomy creation, infants will be randomized to either an intervention or a non-intervention group.

In the intervention group, perioperative MFR between enterostomy creation and reversal will be performed. The control group receives standard care without MFR.

The primary efficacy endpoint of the study is the time to full enteral feeds. Secondary endpoints include first postoperative bowel movement after stoma reversal, postoperative weight gain, and days of postoperative parenteral nutrition. In addition adverse events will be analyzed.
Discussion

The MUC-FIRE trial will be the first prospective randomized trial to investigate the benefits and disadvantages of MFR in infants. The results of the trial are expected to provide an evidence-based foundation for guidelines in pediatric surgical centers worldwide.
Trial registration

The trial has been registered at clinicaltrials.gov (number: NCT03469609, date of registration: March 19, 2018; last update: January 20, 2023, https://clinicaltrials.gov/ct2/show/NCT03469609?term=NCT03469609&draw=2&rank=1).
KW  - Pharmacology
KW  - General Medicine
Y1  - 2023
UR  - https://opus.bibliothek.uni-augsburg.de/opus4/frontdoor/index/index/docId/102312
UR  - https://nbn-resolving.org/urn:nbn:de:bvb:384-opus4-1023121
SN  - 2451-8654
VL  - 32
SP  - 101096
PB  - Elsevier BV
CY  - Amsterdam
ER  -