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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
mucous fistula refeeding
Other interventionTransfer of infants' own stool
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Sponsors and contacts
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University of Leipzig
Lead sponsor
German Research Foundation
Collaborator
Hannover Medical School
Collaborator