Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT02812095
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2016-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C575678', 'term': 'RIFL protein, mouse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of citrulline level during the study period', 'timeFrame': 'up to 6 months of corrected age', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'The pathologic findings after refeeding procedure', 'timeFrame': 'up to 8 weeks of corrected age', 'description': 'villus height, crypt depth, mucosal thickening of pathologic specimens at the time of stoma closure operation'}, {'measure': 'the number of days on parenteral nutrition', 'timeFrame': 'up to 8 weeks of corrected age', 'description': 'the day of discontinuation of intravenous protein supplements'}, {'measure': 'The weight gain', 'timeFrame': 'up to 6 months of corrected age', 'description': 'differences in the admission weight Z-scores and end of study weight Z-scores'}, {'measure': 'Adverse events during refeeding procedure', 'timeFrame': 'up to 8 weeks of corrected age', 'description': 'bowel prolapse, enteral hemorrhage, abdominal distension, infection related stoma'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Enterostomy']}, 'referencesModule': {'references': [{'pmid': '36991415', 'type': 'DERIVED', 'citation': 'Lee ES, Kim EK, Shin SH, Jung YH, Song IG, Kim YJ, Kim HY, Choi YH, Moon KC, Kim B. Efficacy and safety of mucous fistula refeeding in preterm infants: an exploratory randomized controlled trial. BMC Pediatr. 2023 Mar 29;23(1):137. doi: 10.1186/s12887-023-03950-1.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy\n\nExclusion Criteria:\n\n* Congenital gastrointestinal malformation\n* Blind pouch (after laparotomy)\n* Refeeding procedure related infection\n* Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)'}, 'identificationModule': {'nctId': 'NCT02812095', 'briefTitle': 'Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy', 'orgStudyIdInfo': {'id': '1407-193-601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The refeeding group', 'description': 'Refeeding is initiated when 120mL/kg/day of enteral feed reaches or stoma loss exceeds more than 40ml/kg/day after operation.', 'interventionNames': ['Procedure: Refeeding']}, {'type': 'NO_INTERVENTION', 'label': 'The control group'}], 'interventions': [{'name': 'Refeeding', 'type': 'PROCEDURE', 'otherNames': ['extracorporeal stool transport'], 'description': 'when amount of feeding reach to 120mL/kg a day,', 'armGroupLabels': ['The refeeding group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ee-Kyung Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}