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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Enterostomy
• Intervention / Treatment: Other: mucous fistula refeeding

Detailed Description

Enterostomies in children may be created for different reasons. During the presence of an enterostomy the regular stool transfer is interrupted as the distal part of the bowel (the part following the enterostomy) does not participate in the circulation of stool. Therefore it does not contribute to the resorption of enteral contents. As a consequence these children need additional parenteral nutrition. Due to the negative side-effects of parenteral nutrition all patients should return to enteral nutrition as soon as possible. Consequently, many pediatric surgical centers worldwide routinely perform mucous fistula refeeding (MFR) into the former unused bowel after enterostomy creation because case reports and retrospective analyses show low complication rates and faster postoperative weight gain. Several providers, however, shy away from this approach because to date there is still no high quality evidence for the benefit of this Treatment.The aim of this study is to assess the effects of mucous fistula refeeding in a randomized, prospective trial. We hypothesize that MFR between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to the group without refilling. Moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Lacher, Prof. Dr.; Phone Number: 26400 +49-341-97; Email: muc-fire-leipzig@medizin.uni-leipzig.de
• Study Contact Backup: Name: Omid Madadi-Sanjani, Dr. med.; Phone Number: 20192676 +49-176; Email: Madadi-Sanjani.Omid@mh-hannover.de

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Universitätsklinik für Kinder- und Jugendchirurgie
    • Contact: Holger Till, Univ. Prof.
  • Wien, Austria, 1090
    • Recruiting
    • Universitätsklinik für Kinder- und Jugendheilkunde
    • Contact: Christoph Binder, Dr.
• Germany
  • Augsburg, Germany, 86156
    • Recruiting
    • University Hospital Augsburg, Clinic for Pediatric Surgery
    • Contact: Tobias Schuster, Dr. med.
  • Hamburg, Germany, 20246
    • Withdrawn
    • Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]
  • Marburg, Germany, 35043
    • Recruiting
    • University Hospital Marburg, Clinic for Pediatric Surgery
    • Contact: Guido Seitz, Prof. Dr.
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • Universitätsklinik für Kinder- und Jugendmedizin Tübingen
      • Contact: Christian Poets, Prof. Dr.
  • Bayern
    • München, Bayern, Germany, 80804
      • Recruiting
      • Städtisches Klinikum München GmbH/ Klinikum Schwabing
      • Contact: Stuart Hosie, Prof. Dr.
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Terminated
      • Zentrum der Chirurgie, Klinik für Kinderchirurgie
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30173
      • Recruiting
      • Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
      • Contact: Barbara Ludwikowski, PD Dr.
    • Hannover, Niedersachsen, Germany, 30625
      • Recruiting
      • Hannover Medical School, Clinic for Pediatric Surgery
      • Contact: Omid Madadi-Sanjani, Dr.; Email: madadi-sanjani.omid@mh-hannover.de
  • Nordrhein-Westfalen
    • Witten, Nordrhein-Westfalen, Germany, 58452
      • Recruiting
      • Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
      • Contact: Jochen Hubertus, Prof. Dr.
      • Contact: Maximilian Jaeger, Dr.
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Withdrawn
      • Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
  • Sachsen
    • Dresden, Sachsen, Germany, 01304
      • Terminated
      • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
    • Leipzig, Sachsen, Germany, 04103
      • Recruiting
      • University of Leipzig
      • Contact: Martin Lacher, Prof. Dr.; Email: muc-fire-leipzig@medizin.uni-leipzig.de
• Netherlands
  • Amsterdam, Netherlands, 1000 GG
    • Recruiting
    • Amsterdam University Medical Centers
    • Contact: Ernest van Heurn, Prof. Dr.
  • Rotterdam, Netherlands, 3015 CE
    • Recruiting
    • Erasmus University Medical Center Rotterdam
    • Contact: R. M. H Wijnen, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perioperative mucous fistula refeeding; Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure	Other: mucous fistula refeeding; Transfer of infants' own stool
No Intervention: No mucous fistula refeeding; No perioperative mucous fistula refeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to full enteral feeds (hours)	Time to full feeds (hours), defined as time to actual enteral intake of the age-dependent caloric requirements per day (defined as 90 or 120kcal/kg/24h) for at least 24 hours and a concomitant reduction of parenteral fluids to <20ml/kg/24h.; The nutrition aim is 120 kcal/kg/24h for premature infants with a birth weight < 1000g or premature infants with a birth weight ≥ 1000g and mother's gestation week at birth before 37+0.; The nutrition aim is 90 kcal/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.	week 4 to week 12 daily

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first bowel movement	Cleaning and changing of infants diapers will be performed according to a fixed schedule in order to uniformly document the time to first bowel movement	Week 4 to week 12 daily
Thriving	Measurement of body weight	Week 1 to week 12 daily; follow-up (month 3, 6, 12)
Z-Score (standard deviation score)	Measurement of weight [weight for age, World Health Organization (WHO)]	Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Number of days of postoperative total parenteral nutrition (TPN)	Calculation of days of postoperative TPN starts on the day of operation and ends on the day of full enteral nutrition	Week 2 to week 12 daily, follow-up (month 3, 6, 12)
Laboratory parameter indicating cholestasis	Measurement of conjugated Bilirubin (µmol/l)	Week 1 to week 12 daily, follow-up (month 3)
Assessment of adverse events (AEs)	Adverse events will be collected by the investigator either based on the information provided spontaneously by the parents of patient or evaluated by non-suggestive questions.	Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Assessment of serious adverse events (SAEs)	Adverse events will be collected by the investigator either based on the information provided spontaneously by the parents of patient or evaluated by non-suggestive questions.	Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Postoperative weight gain (g/d)	Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure	week 4 to week 12
Central venous line (CVL)	duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)	Week 1 to week 12
hospitalisation	Length of hospital stay (days)	week 1 to week 12
jump in caliber	Estimated ratio of the diameter of the two bowel loops which are anastomosed.	week 5
Sodium resorption	Sodium in Urine (mmol/l)	Week 1 to week 12 daily, follow-up (month 3)
Status of liver enzymes	Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)	Week 1 to week 12 daily, follow-up (month 3)
Laboratory parameters	Haemoglobin (g/dl)	Week 1 to week 12 daily, follow-up (month 3)
Time to full volume intake per day (in hours)	Time to full age-dependent volume intake per day (defined as 150ml/kg/24h for premature infants and 120ml/kg/24h for mature born infants as well as corrected mature infants) (in hours).; The volume aim is 150 ml/kg/24h for premature infants with a birth weight < 1000g or premature infants with a birth weight ≥ 1000g and mother's gestation week at birth before 37+0.; The volume aim is 120 ml/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.	week 4 to week 12 daily

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: German Research Foundation; Hannover Medical School
• Investigators: Principal Investigator: Omid Madadi-Sanjani, Dr. med., Hannover Medical School, Department of Pediatric Surgery; Principal Investigator: Martin Lacher, Prof. Dr., University of Leipzig, Department of Pediatric Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: infants; enteral feeding; length of hospital stay; refeeding; necrotizing enterocolitis (NEC); focal intestinal perforation (FIP); enterostomy creation; bowel reanastomosis; caloric intake; parenteral nutrition; complication rate; reduction of hospital expenses
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula
• Other Study ID Numbers: MUC-FIRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No