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

ConditionEnterostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorUniversity of Leipzig

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

resection of ileocecal valve,

colostomy,

small bowel atresia,

multiple ostomies (more than just an enterostomy and a mucous fistula),

Trial design

Design model

Parallel

Treatments tested in this trial

  • mucous fistula refeeding

    Other intervention

    Transfer of infants' own stool

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Perioperative mucous fistula refeedingExperimental treatment 1 intervention
Group B: No mucous fistula refeedingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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. 1. 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. 2. 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 outcomes

1

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

Time frame
Week 4 to week 12 daily
2

Thriving

Measurement of body weight

Time frame
Week 1 to week 12 daily; follow-up (month 3, 6, 12)
3

Z-Score (standard deviation score)

Measurement of weight \[weight for age, World Health Organization (WHO)\]

Time frame
Week 1 to week 12 daily, follow-up (month 3, 6, 12)
4

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

Time frame
Week 2 to week 12 daily, follow-up (month 3, 6, 12)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leipzig

Lead sponsor

German Research Foundation

Collaborator

Hannover Medical School

Collaborator