Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 1:45 PM
Study NCT ID:
NCT02475759
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2015-03-10', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'daily feeding characteristics', 'timeFrame': 'admission', 'description': 'daily feeding characteristics'}, {'measure': 'anthropometric and laboratory measure', 'timeFrame': 'admission', 'description': 'anthropometric and laboratory measure'}], 'secondaryOutcomes': [{'measure': 'length of ICU stay', 'timeFrame': '3weeks', 'description': 'length of ICU stay'}, {'measure': 'duration of mechanical ventilation and extubation timing', 'timeFrame': '3 weeks', 'description': 'total days of mechanical ventilation'}, {'measure': 'postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal', 'timeFrame': 'admission', 'description': 'same as above'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.', 'detailedDescription': 'Nutritional Prehabilitation Program and Cardiac Surgery in Pediatrics. A randomized controlled trial to compare the outcome of malnourished congenital heart surgery patients who randomly received nutritional rehabilitation program 2 weeks and 1 week before surgical intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'The study included all infants with CHD, admitted to the cardiothoracic unit for either palliative or corrective surgery, and suffering from nutritional deficiencies with moderate or severe malnutrition .\n\nInfants received long-term nutritional prehabiliatation. Those with congenital or acquired anomaly of the gastrointestinal tract; multiple congenital anomalies; chromosomal, metabolic,or endocrine diseases; any systemic illness; or fever or infection within 1 wk before the study entry were excluded'}, 'identificationModule': {'nctId': 'NCT02475759', 'briefTitle': 'Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ASU 015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'two weeks prehabilitation group', 'description': 'Nutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children', 'interventionNames': ['Dietary Supplement: Nutritional perioperative prehabilitation program for two weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'one week prehabilitation group', 'description': 'Nutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children', 'interventionNames': ['Dietary Supplement: Nutritional perioperative prehabilitation program for one week']}], 'interventions': [{'name': 'Nutritional perioperative prehabilitation program for two weeks', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutritional perioperative prehabilitation program'], 'description': 'nutritional intervention received two weeks before surgical intervention', 'armGroupLabels': ['two weeks prehabilitation group']}, {'name': 'Nutritional perioperative prehabilitation program for one week', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutritional perioperative prehabilitation program'], 'description': 'nutritional intervention received one weeks before surgical intervention', 'armGroupLabels': ['one week prehabilitation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11517', 'city': 'Cairo', 'country': 'Egypt', 'facility': '38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Rania Ali El-Farrash', 'investigatorAffiliation': 'Ain Shams University'}}}}