Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT03914560
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Intakes in Burn Patients Treated as Outpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nutritional intakes', 'timeFrame': 'During the first week following injury', 'description': 'Using a standardized food questionnaire, mean daily nutritional intakes were calculated for each patient (macronutrients and micronutrients). Food questionnaire is a questionnaire created by our dietetics unit, aiming to quantify the amount of food eaten at each meal. Quantities of macronutrients and micronutrients at each meal were then calculated using tables of food content (Nubel for all nutrients, excepting vitamin E calculated according Ciqual table).'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'During the first week following injury', 'description': 'Body composition measured using bio impedance'}, {'measure': 'Handgrip strength', 'timeFrame': 'During the first week following injury', 'description': 'Strength measured an handheld dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burns', 'Nutritional Deficiency']}, 'descriptionModule': {'briefSummary': 'Nutrition is a key component of burn care. The primary goal of nutrition is to provide adequate supply in macro and micronutrients that are necessary to maintain organ function but also to wound healing, infection control and muscle preservation.\n\nStudies about nutrition and burn care are mainly focused on severe burn patients. There is a few or no data regarding nutrition in minor burns. Those patients rarely receive a multidisciplinary approach, at least in Belgium.\n\nThe present study aimed to describe the nutritional condition of less severe burn patients treated as outpatients in a Belgian burn center. The ultimate goal was to determine whether this population needs specific dietetics follow-up or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All burn patients admitted in the outpatient clinic of the investigator's burn center for minor burns", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Burn treated exclusively in an outpatient clinic\n\nExclusion Criteria:\n\n* Not french speaking\n* Psychiatric disorders\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT03914560', 'briefTitle': 'Nutritional Intakes in Burn Patients Treated as Outpatients', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Evaluation of Macronutrients and Micronutrients Intakes in Burn Patients Treated as Outpatients', 'orgStudyIdInfo': {'id': 'ABA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Burn injury', 'type': 'OTHER', 'description': 'minor burn injury'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'University Hospital of Li§ge', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinic, Principal investigator', 'investigatorFullName': 'Rousseau', 'investigatorAffiliation': 'University of Liege'}}}}