Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 8:36 AM
Study NCT ID:
NCT01464866
Status:
COMPLETED
Last Update Posted:
2012-09-06
First Post:
2011-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nutritional Supplementation on Pediatric Burn Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005521', 'term': 'Food Service, Hospital'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D005522', 'term': 'Food Services'}, {'id': 'D019649', 'term': 'Food Industry'}, {'id': 'D007221', 'term': 'Industry'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D006748', 'term': 'Hospital Departments'}, {'id': 'D006739', 'term': 'Hospital Administration'}, {'id': 'D058016', 'term': 'Health Facility Administration'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D004045', 'term': 'Dietary Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2011-11-01', 'studyFirstSubmitQcDate': '2011-11-02', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prealbumin', 'timeFrame': 'Change between Baseline and Day 14'}], 'secondaryOutcomes': [{'measure': 'Preablumin', 'timeFrame': 'Change between Baseline and Day 7'}, {'measure': 'C Reactive Protein (CRP)', 'timeFrame': 'Between baseline and Day 7'}, {'measure': 'C Reactive Protein', 'timeFrame': 'Between baseline and Day 14'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 1-10 years of age\n2. Hospital admission within 24 hours post-burn\n3. At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher\n4. Capable of exclusive oral feeding within 3 days of hospitalization\n5. Expected to be hospitalized at least 14 days\n\nExclusion Criteria:\n\n1. History diabetes or stress-induced hyperglycemia\n2. Artificial ventilation\n3. Requires parenteral or enteral feeding\n4. IV albumin\n5. Drug that affects metabolism\n6. Receiving Dialysis\n7. Acutely impacted or constipated\n8. Consumes non-study nutritional supplement\n9. Allergy or intolerance to any study product ingredient\n10. Participating in non-Abbott approved concomitant trial'}, 'identificationModule': {'nctId': 'NCT01464866', 'briefTitle': 'Effect of Nutritional Supplementation on Pediatric Burn Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Effect of Nutritional Supplementation on Pediatric Burn Patients', 'orgStudyIdInfo': {'id': 'BK56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hospital Feed', 'description': 'Standard hospital food', 'interventionNames': ['Other: Hospital food']}, {'type': 'EXPERIMENTAL', 'label': 'Hospital Feed plus nutritional supplement', 'description': 'Standard hospital food plus nutritional supplement', 'interventionNames': ['Other: Nutritional Supplement']}], 'interventions': [{'name': 'Nutritional Supplement', 'type': 'OTHER', 'description': 'Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.', 'armGroupLabels': ['Hospital Feed plus nutritional supplement']}, {'name': 'Hospital food', 'type': 'OTHER', 'description': 'Typical hospital food given daily at meals', 'armGroupLabels': ['Hospital Feed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '426039', 'city': 'Izhevsk', 'country': 'Russia', 'facility': 'First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'zip': '420138', 'city': "Kazan'", 'country': 'Russia', 'facility': "Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic", 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '650033', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'City Clinical Hospital #2', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '123317', 'city': 'Moscow', 'country': 'Russia', 'facility': "Children's City Hospital #9", 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603155', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '344091', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'City Hospital #20', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '198205', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': "Children's City Hospital #1", 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410005', 'city': 'Saratov', 'country': 'Russia', 'facility': 'City Clinical Hospital #7', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '620134', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Children City Clinical Hospital #9', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Jennifer Williams, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}