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Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02812095
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : April 4, 2019
Information provided by (Responsible Party):
Ee-Kyung Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Enterostomy Procedure: Refeeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
Study Start Date : August 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: 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.
Procedure: Refeeding
when amount of feeding reach to 120mL/kg a day,
Other Name: extracorporeal stool transport

No Intervention: The control group

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02812095

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Contact: Seung Han Shin, M.D. 0220727230 ext 82
Contact: Ee-Kyung Kim, M.D., PhD. 0220723628 ext 82

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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Seung Han Shin, MD    +82220727230   
Contact: Ee-Kyung Kim, MD, Ph D    +82220723628   
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Ee-Kyung Kim, Professor, Seoul National University Hospital Identifier: NCT02812095    
Other Study ID Numbers: 1407-193-601
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes