Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2020-04-16

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.

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Detailed Description

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Conditions

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Enterostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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The refeeding group

Refeeding is initiated when 120mL/kg/day of enteral feed reaches or stoma loss exceeds more than 40ml/kg/day after operation.

Group Type EXPERIMENTAL

Refeeding

Intervention Type PROCEDURE

when amount of feeding reach to 120mL/kg a day,

The control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Refeeding

when amount of feeding reach to 120mL/kg a day,

Intervention Type PROCEDURE

Other Intervention Names

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extracorporeal stool transport

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)

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No