Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-01 @ 5:58 PM
Study NCT ID:
NCT04609358
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Algorithm for Enteral Nutrition Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-25', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2020-10-25', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malnutrition recovery', 'timeFrame': '1 year', 'description': 'Malnutrition was assessed as recovering from malnutrition'}], 'secondaryOutcomes': [{'measure': 'Feeding intolerance', 'timeFrame': '1 year', 'description': 'According to the criteria established by the American Academy of Pediatrics in 2003, the following symptoms are diagnosed as feeding intolerance: severe abdominal distension or discoloration; Signs of intestinal perforation; Obvious blood stool; Gastric retention ≥ 25% of the total amount after 2 to 3 feeding intervals; Bile reflux or vomiting; Severe apnea or bradycardia; Severe cardiopulmonary insufficiency; Apnea: Cessation of breathing for ≥20 seconds, or cessation of breathing accompanied by a decrease in SpO2.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition Disorder, Child']}, 'referencesModule': {'references': [{'pmid': '34765467', 'type': 'DERIVED', 'citation': 'Chen X, Zhang M, Song Y, Luo Y, Wang L, Xu Z, Bao N. Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial. Transl Pediatr. 2021 Oct;10(10):2439-2448. doi: 10.21037/tp-21-360.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease', 'detailedDescription': 'In many developing countries, pediatric cardiac programs are not fully established, and nutrition support algorithm is lack. Therefore, this study aimed to evaluate the the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease. The usual standard practice for feeding often interrupted by retention in the gut and then choose the parenteral nutrition support especially in the patients with unstable hemodynamic status. Actually tiny and continuous feeding would improve the gut function and reach the adequate energy supply.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nweight-for-age of z-score \\<-2; or length-for-age of z score \\<-2; or weight-for-length of z score \\<-2\n\nExclusion Criteria:\n\nAny patient with congenital genetic metabolic diseases'}, 'identificationModule': {'nctId': 'NCT04609358', 'briefTitle': 'Efficacy and Safety of the Algorithm for Enteral Nutrition Support', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support Compared With Traditional Practice in Children With Congenital Heart Disease: Randomized Clinical Trial, Simple Blind.', 'orgStudyIdInfo': {'id': 'SCMCIRB-K2015003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': "The patients' nutrition were supported according the the algorithm of the enteral nutrition.", 'interventionNames': ['Other: intervention group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "The patients' nutrition were supported according the prescription of the physicians and dietician in our hospital."}], 'interventions': [{'name': 'intervention group', 'type': 'OTHER', 'description': "When patients' hemodynamics was stable, start 1-2ml/kg/hr post-op 6-12 hours and increased 1-2ml/kg/hr each day if tolerating to reach the target energy supply When patients' hemodynamics wasn't stable, start post-op 6-12 hours 0.5-1ml/kg/hr and increased 0.5-1ml/kg/hr each day if tolerating to reach the target energy supply.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhuoming Xu, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Shanghai Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of CICU', 'investigatorFullName': 'Xu Zhuoming', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}