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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2024

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.

Interventions

  • Other: mucous fistula refeeding
    • Transfer of infants’ own stool

Arms, Groups and Cohorts

  • Experimental: Perioperative mucous fistula refeeding
    • Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure
  • No Intervention: No mucous fistula refeeding
    • No perioperative mucous fistula refeeding

Clinical Trial Outcome Measures

Primary Measures

  • Time to full enteral feeds (hours)
    • Time Frame: week 4 to week 12 daily
    • 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 Measures

  • Time to first bowel movement
    • Time Frame: Week 4 to week 12 daily
    • 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
    • Time Frame: Week 1 to week 12 daily; follow-up (month 3, 6, 12)
    • Measurement of body weight
  • Z-Score (standard deviation score)
    • Time Frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
    • Measurement of weight [weight for age, World Health Organization (WHO)]
  • Number of days of postoperative total parenteral nutrition (TPN)
    • Time Frame: Week 2 to week 12 daily, follow-up (month 3, 6, 12)
    • 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
    • Time Frame: Week 1 to week 12 daily, follow-up (month 3)
    • Measurement of conjugated Bilirubin (µmol/l)
  • Assessment of adverse events (AEs)
    • Time Frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
    • 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)
    • Time Frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
    • 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)
    • Time Frame: week 4 to week 12
    • Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure
  • Central venous line (CVL)
    • Time Frame: Week 1 to week 12
    • duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)
  • hospitalisation
    • Time Frame: week 1 to week 12
    • Length of hospital stay (days)
  • jump in caliber
    • Time Frame: week 5
    • Estimated ratio of the diameter of the two bowel loops which are anastomosed.
  • Sodium resorption
    • Time Frame: Week 1 to week 12 daily, follow-up (month 3)
    • Sodium in Urine (mmol/l)
  • Status of liver enzymes
    • Time Frame: Week 1 to week 12 daily, follow-up (month 3)
    • Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)
  • Laboratory parameters
    • Time Frame: Week 1 to week 12 daily, follow-up (month 3)
    • Haemoglobin (g/dl)
  • Time to full volume intake per day (in hours)
    • Time Frame: week 4 to week 12 daily
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 12 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Leipzig
  • Collaborator
    • German Research Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Martin Lacher, Prof. Dr. med. – University of Leipzig
  • Overall Official(s)
    • 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
  • Overall Contact(s)
    • Martin Lacher, Prof. Dr., +49-341-97, muc-fire-leipzig@medizin.uni-leipzig.de

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.