Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Conditions
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Enterostomy

Intervention / Treatment
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* Procedure: Refeeding


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The refeeding group<br>Refeeding is initiated when 120mL/kg/day of enteral feed reaches or stoma loss exceeds more than 40ml/kg/day after operation. | Procedure: Refeeding<br>* when amount of feeding reach to 120mL/kg a day,<br>* Other names: extracorporeal stool transport;|
| No Intervention: The control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of citrulline level during the study period | 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 | up to 6 months of corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pathologic findings after refeeding procedure | villus height, crypt depth, mucosal thickening of pathologic specimens at the time of stoma closure operation | up to 8 weeks of corrected age | 
| the number of days on parenteral nutrition | the day of discontinuation of intravenous protein supplements | up to 8 weeks of corrected age | 
| The weight gain | differences in the admission weight Z-scores and end of study weight Z-scores | up to 6 months of corrected age | 
| Adverse events during refeeding procedure | bowel prolapse, enteral hemorrhage, abdominal distension, infection related stoma | up to 8 weeks of corrected age |