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.

Autor:	Großhennig A; Institute of Biostatistics, Hannover Medical School, Germany., Wiesner S; Institute of Biostatistics, Hannover Medical School, Germany., Hellfritsch J; Department of Pediatric Surgery, University of Leipzig, Germany., Thome U; Department of Neonatology, University of Leipzig, Germany., Knüpfer M; Department of Neonatology, University of Leipzig, Germany., Peter C; Department of Pediatric Pulmonology, Allergology, Diabetology, Rheumatology and Neonatology, Hannover Medical School, Germany., Metzelder M; Department of Pediatric and Adolescent Surgery, Medical University of Vienna, Austria., Binder C; Department of Pediatric and Adolescent Medicine, Medical University of Vienna, Austria., Wanz U; Division of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria., Flucher C; Department of Paediatric and Adolescent Surgery, Medical University of Graz, Graz, Austria., Brands BO; Departments of Pediatric Surgery and Neonatology, Munich Municipal Hospital, Germany., Mollweide A; Departments of Pediatric Surgery and Neonatology, Munich Municipal Hospital, Germany., Ludwikowski B; Department of Pediatric Surgery, Children's and Youth Hospital 'Auf der Bult' Hannover, Germany., Koluch A; Department of Pediatric Surgery, Children's and Youth Hospital 'Auf der Bult' Hannover, Germany., Scherer S; Department of Pediatric Surgery, University Children's Hospital Tuebingen, Germany., Gille C; Department of Neonatology, University Children's Hospital Tuebingen, Germany., Theilen TM; Department of Pediatric Surgery and Urology, University Hospital Frankfurt, Germany., Rochwalsky U; Department of Neonatology, University Hospital Frankfurt, Germany., Karpinski C; Department of Pediatric Surgery, University Hospital Dresden, Germany., Schulze A; Department of Pediatric Surgery, University Hospital Dresden, Germany., Schuster T; Department of Pediatric Surgery, University Medical Center Augsburg, Germany., Weber F; Department of Pediatric Surgery, University Medical Center Augsburg, Germany., Seitz G; Department of Pediatric Surgery, University Children's Hospital, Marburg, Germany., Gesche J; Department of Pediatric Surgery, University Children's Hospital, Marburg, Germany., Nissen M; Department of Pediatric Surgery of the Ruhr University Bochum, Marien Hospital Witten, Witten, Germany., Jäger M; Department of Neonatology, Marien Hospital Witten, Witten, Germany., Koch A; Institute of Biostatistics, Hannover Medical School, Germany., Ure B; Department of Pediatric Surgery, Hannover Medical School, Germany., Madadi-Sanjani O; Department of Pediatric Surgery, Hannover Medical School, Germany., Lacher M; Department of Pediatric Surgery, University of Leipzig, Germany.
Jazyk:	angličtina
Zdroj:	Contemporary clinical trials communications [Contemp Clin Trials Commun] 2023 Feb 20; Vol. 32, pp. 101096. Date of Electronic Publication: 2023 Feb 20 (Print Publication: 2023).
DOI:	10.1016/j.conctc.2023.101096
Abstrakt:	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 MUC ous FI stula RE feeding (" 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). Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2023 The Authors.)
Databáze:	MEDLINE
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