- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02812095
Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
March 16, 2021 updated by: Ee-Kyung Kim, Seoul National University Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: The control group
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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.
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when amount of feeding reach to 120mL/kg a day,
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of citrulline level during the study period
Time Frame: up to 6 months of corrected age
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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
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up to 6 months of corrected age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pathologic findings after refeeding procedure
Time Frame: up to 8 weeks of corrected age
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villus height, crypt depth, mucosal thickening of pathologic specimens at the time of stoma closure operation
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up to 8 weeks of corrected age
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the number of days on parenteral nutrition
Time Frame: up to 8 weeks of corrected age
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the day of discontinuation of intravenous protein supplements
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up to 8 weeks of corrected age
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The weight gain
Time Frame: up to 6 months of corrected age
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differences in the admission weight Z-scores and end of study weight Z-scores
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up to 6 months of corrected age
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Adverse events during refeeding procedure
Time Frame: up to 8 weeks of corrected age
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bowel prolapse, enteral hemorrhage, abdominal distension, infection related stoma
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up to 8 weeks of corrected age
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
December 11, 2019
Study Completion (Actual)
April 16, 2020
Study Registration Dates
First Submitted
June 6, 2016
First Submitted That Met QC Criteria
June 21, 2016
First Posted (Estimate)
June 24, 2016
Study Record Updates
Last Update Posted (Actual)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1407-193-601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Enterostomy
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Hospices Civils de LyonCompleted
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BBraun Medical SASCompleted
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Rennes University HospitalMaastricht University Medical CenterCompletedDouble EnterostomyFrance, Netherlands
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BBraun Medical SASUnknown
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Rigshospitalet, DenmarkHerlev HospitalCompletedIleostomy - Stoma | Colostomy | Enterostomy
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BBraun Medical SASRecruitingEnterostomy | Stoma Ileostomy | Stoma ColostomySpain
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Hospices Civils de LyonUnknownIntestinal Failure With a Temporary High-output Double EnterostomyFrance
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University of LeipzigGerman Research Foundation; Hannover Medical SchoolRecruitingEnterostomyAustria, Germany, Netherlands
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Chang Gung Memorial HospitalCompletedQuality of Life | Enterostomy | Self-care | Multimedia Learning EducationTaiwan
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Universidade do PortoUniversidade Nova de Lisboa; CINTESIS - Center for Health Technology and Services... and other collaboratorsUnknownNewborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal PerforationPortugal
Clinical Trials on Refeeding
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Yonsei UniversityRecruiting
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University of California, San FranciscoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
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University Hospital, Strasbourg, FranceUnknownPost-operative Vomiting Incidence | Pediatric Day Case SurgeryFrance
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Dayanand Medical College and HospitalCompletedAcute Gastroesophageal Variceal BleedingIndia
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Hospital Regional de Alta Especialidad del BajioCompleted
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University of LeipzigGerman Research Foundation; Hannover Medical SchoolRecruitingEnterostomyAustria, Germany, Netherlands
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University of California, San FranciscoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsEnrolling by invitationAtypical Anorexia NervosaUnited States
-
Samsun UniversityRecruiting
-
Children's Mercy Hospital Kansas CityCompleted
-
Pennington Biomedical Research CenterTulane UniversityNot yet recruitingObesity | Underweight