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

Primary Purpose

Enterostomy

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
mucous fistula refeeding
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enterostomy focused on measuring 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

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinik für Kinder- und JugendchirurgieRecruiting
  • Universitätsklinik für Kinder- und JugendheilkundeRecruiting
  • Universitätsklinik für Kinder- und Jugendmedizin TübingenRecruiting
  • Städtisches Klinikum München GmbH/ Klinikum SchwabingRecruiting
  • Zentrum der Chirurgie, Klinik für Kinderchirurgie
  • Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und KinderurologieRecruiting
  • Hannover Medical School, Clinic for Pediatric SurgeryRecruiting
  • Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric SurgeryRecruiting
  • Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
  • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
  • University of LeipzigRecruiting
  • University Hospital Augsburg, Clinic for Pediatric SurgeryRecruiting
  • Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]
  • University Hospital Marburg, Clinic for Pediatric SurgeryRecruiting
  • Amsterdam University Medical Centers
  • Erasmus University Medical Center RotterdamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Perioperative mucous fistula refeeding

No mucous fistula refeeding

Arm Description

Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure

No perioperative mucous fistula refeeding

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Thriving
Measurement of body weight
Z-Score (standard deviation score)
Measurement of weight [weight for age, World Health Organization (WHO)]
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
Laboratory parameter indicating cholestasis
Measurement of conjugated Bilirubin (µmol/l)
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.
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.
Postoperative weight gain (g/d)
Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure
Central venous line (CVL)
duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)
hospitalisation
Length of hospital stay (days)
jump in caliber
Estimated ratio of the diameter of the two bowel loops which are anastomosed.
Sodium resorption
Sodium in Urine (mmol/l)
Status of liver enzymes
Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)
Laboratory parameters
Haemoglobin (g/dl)
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.

Full Information

First Posted
February 28, 2018
Last Updated
July 6, 2023
Sponsor
University of Leipzig
Collaborators
German Research Foundation, Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03469609
Brief Title
Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
Acronym
MUC-FIRE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
German Research Foundation, Hannover Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterostomy
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, open-label, randomized, parallel group, controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perioperative mucous fistula refeeding
Arm Type
Experimental
Arm Description
Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure
Arm Title
No mucous fistula refeeding
Arm Type
No Intervention
Arm Description
No perioperative mucous fistula refeeding
Intervention Type
Other
Intervention Name(s)
mucous fistula refeeding
Intervention Description
Transfer of infants' own stool
Primary Outcome Measure Information:
Title
Time to full enteral feeds (hours)
Description
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.
Time Frame
week 4 to week 12 daily
Secondary Outcome Measure Information:
Title
Time to first bowel movement
Description
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
Time Frame
Week 4 to week 12 daily
Title
Thriving
Description
Measurement of body weight
Time Frame
Week 1 to week 12 daily; follow-up (month 3, 6, 12)
Title
Z-Score (standard deviation score)
Description
Measurement of weight [weight for age, World Health Organization (WHO)]
Time Frame
Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Title
Number of days of postoperative total parenteral nutrition (TPN)
Description
Calculation of days of postoperative TPN starts on the day of operation and ends on the day of full enteral nutrition
Time Frame
Week 2 to week 12 daily, follow-up (month 3, 6, 12)
Title
Laboratory parameter indicating cholestasis
Description
Measurement of conjugated Bilirubin (µmol/l)
Time Frame
Week 1 to week 12 daily, follow-up (month 3)
Title
Assessment of adverse events (AEs)
Description
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.
Time Frame
Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Title
Assessment of serious adverse events (SAEs)
Description
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.
Time Frame
Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Title
Postoperative weight gain (g/d)
Description
Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure
Time Frame
week 4 to week 12
Title
Central venous line (CVL)
Description
duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)
Time Frame
Week 1 to week 12
Title
hospitalisation
Description
Length of hospital stay (days)
Time Frame
week 1 to week 12
Title
jump in caliber
Description
Estimated ratio of the diameter of the two bowel loops which are anastomosed.
Time Frame
week 5
Title
Sodium resorption
Description
Sodium in Urine (mmol/l)
Time Frame
Week 1 to week 12 daily, follow-up (month 3)
Title
Status of liver enzymes
Description
Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)
Time Frame
Week 1 to week 12 daily, follow-up (month 3)
Title
Laboratory parameters
Description
Haemoglobin (g/dl)
Time Frame
Week 1 to week 12 daily, follow-up (month 3)
Title
Time to full volume intake per day (in hours)
Description
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.
Time Frame
week 4 to week 12 daily

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants < 366 days, Ileostomy / Jejunostomy, double loop enterostomies and split enterostomies (with mucous fistula) 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: resection of ileocecal valve, colostomy, small bowel atresia, multiple ostomies (more than just an enterostomy and a mucous fistula), chromosomal abnormalities (if known at the time of randomization), Hirschsprung's disease, participation in another drug-intervention study Intestinal perforation due to a hemodynamic heart defect
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Lacher, Prof. Dr.
Phone
+49-341-97
Ext
26400
Email
muc-fire-leipzig@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Omid Madadi-Sanjani, Dr. med.
Phone
+49-176
Ext
20192676
Email
Madadi-Sanjani.Omid@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omid Madadi-Sanjani, Dr. med.
Organizational Affiliation
Hannover Medical School, Department of Pediatric Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Lacher, Prof. Dr.
Organizational Affiliation
University of Leipzig, Department of Pediatric Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinik für Kinder- und Jugendchirurgie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Till, Univ. Prof.
Facility Name
Universitätsklinik für Kinder- und Jugendheilkunde
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Binder, Dr.
Facility Name
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Poets, Prof. Dr.
Facility Name
Städtisches Klinikum München GmbH/ Klinikum Schwabing
City
München
State/Province
Bayern
ZIP/Postal Code
80804
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Hosie, Prof. Dr.
Facility Name
Zentrum der Chirurgie, Klinik für Kinderchirurgie
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Terminated
Facility Name
Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30173
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Ludwikowski, PD Dr.
Facility Name
Hannover Medical School, Clinic for Pediatric Surgery
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omid Madadi-Sanjani, Dr.
Email
madadi-sanjani.omid@mh-hannover.de
Facility Name
Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58452
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jochen Hubertus, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Maximilian Jaeger, Dr.
Facility Name
Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01304
Country
Germany
Individual Site Status
Terminated
Facility Name
University of Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Lacher, Prof. Dr.
Email
muc-fire-leipzig@medizin.uni-leipzig.de
Facility Name
University Hospital Augsburg, Clinic for Pediatric Surgery
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Schuster, Dr. med.
Facility Name
Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Withdrawn
Facility Name
University Hospital Marburg, Clinic for Pediatric Surgery
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido Seitz, Prof. Dr.
Facility Name
Amsterdam University Medical Centers
City
Amsterdam
ZIP/Postal Code
1000 GG
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernest van Heurn, Prof. Dr.
Facility Name
Erasmus University Medical Center Rotterdam
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. M. H Wijnen, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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