Enterostomy
Conditions
Brief summary
Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the efficacy and safety of the practice of refeeding in preterm infants with enterostomy. Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other laboratory findings will be collected. Serial citrulline levels during refeeding procedure and pathologic specimens of bowel (at the time of stoma closure) will be collected for evaluating bowel adaptation.
Interventions
PROCEDURERefeeding
when amount of feeding reach to 120mL/kg a day,
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 35 Weeks
Healthy volunteers
No
Inclusion criteria
* Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy
Exclusion criteria
* Congenital gastrointestinal malformation * Blind pouch (after laparotomy) * Refeeding procedure related infection * Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of citrulline level during the study period | up to 6 months of corrected age | 4 time points: at the time of full enteral feeding (\>120 cc/kg/day), 4 weeks later after full enteral feeding, at the time of stoma closure operation, 12 weeks later after closure operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The pathologic findings after refeeding procedure | up to 8 weeks of corrected age | villus height, crypt depth, mucosal thickening of pathologic specimens at the time of stoma closure operation |
| the number of days on parenteral nutrition | up to 8 weeks of corrected age | the day of discontinuation of intravenous protein supplements |
| The weight gain | up to 6 months of corrected age | differences in the admission weight Z-scores and end of study weight Z-scores |
| Adverse events during refeeding procedure | up to 8 weeks of corrected age | bowel prolapse, enteral hemorrhage, abdominal distension, infection related stoma |
Countries
South Korea
Outcome results
None listed