Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT02293434
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2014-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Status on Admission to Pediatric Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'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': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-19', 'studyFirstSubmitDate': '2014-08-11', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional status', 'timeFrame': 'Baseline', 'description': 'Nutritional status (measurement of simple anthropometric parameters, which are then used to calculate malnutrition indices) on admission'}], 'secondaryOutcomes': [{'measure': 'Nutritional practice in PICUs', 'timeFrame': '1 day ( once during the study)', 'description': 'Nutritional practice in PICUs once during the study : two questionnaires (medical and nursing) sent to all participating hospitals'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Malnutrition', 'Status Nutritional Weight', 'Pediatric intensive care'], 'conditions': ['Malnutrition', 'Dwarf - Nutritional']}, 'descriptionModule': {'briefSummary': "Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.\n\nAs malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.\n\nPrimary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.\n\nSecondary objectives:\n\n* Determine the children's nutritional status on admission.\n* Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).\n* Describe the practices regarding nutritional care in each center.\n\nPopulation: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.", 'detailedDescription': "Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.\n\nAs malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.\n\nPrimary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.\n\nSecondary objectives:\n\n* Determine the children's nutritional status on admission.\n* Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).\n* Describe the practices regarding nutritional care in each center.\n\nStudy design:\n\n* Type of study: Observational, descriptive, transversal, and multicentric.\n* Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.\n* Primary assessment parameter: Malnutrition, as defined by the body mass index (BMI) value \\<-2 SD, according to the WHO Child Growth Standards.\n* Factors studied:\n\n * Nutritional status on admission based on the measurement of simple anthropometric parameters: weight (W), height (H), head circumference (HC) and mid-upper arm circumference (MUAC), which are then used to calculate malnutrition indices.\n * Profile of malnourished patients in relation to hospitalization parameters (age, sex, reason for admission, history, dietary habits).\n * Nutritional practices in PICUs assessed with two questionnaires (medical and nursing) sent to all participating hospitals.\n* Sample size: Number of subjects needed to estimate the prevalence of malnutrition, based on the data in the literature with a confidence interval of 95%±3.2%: 600."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All children (1 month to 18 years) admitted to all PICUs in France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT02293434', 'acronym': 'NUTRI-REAPED', 'briefTitle': 'Nutritional Status on Admission to Pediatric Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Nutritional Status on Admission to Pediatric Intensive Care: A French Multicentric Study', 'orgStudyIdInfo': {'id': '9251'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Children (1 month to 18 years)', 'description': 'All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Aurélien JACQUOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}