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Completed

NCT Number: NCT02812095

Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

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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Key information

Conditions

Enterostomy

Age range

Up to 35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Refeeding

Procedure

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

Other names: extracorporeal stool transport

Primary outcomes

  1. The change of citrulline level during the study period

    Time frame: 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 outcomes

  1. The pathologic findings after refeeding procedure

    Time frame: up to 8 weeks of corrected age

    villus height, crypt depth, mucosal thickening of pathologic specimens at the time of stoma closure operation

  2. the number of days on parenteral nutrition

    Time frame: up to 8 weeks of corrected age

    the day of discontinuation of intravenous protein supplements

  3. The weight gain

    Time frame: up to 6 months of corrected age

    differences in the admission weight Z-scores and end of study weight Z-scores

  4. Adverse events during refeeding procedure

    Time frame: up to 8 weeks of corrected age

    bowel prolapse, enteral hemorrhage, abdominal distension, infection related stoma

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jun 24, 2016
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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