Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT04482218
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2020-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology', 'timeFrame': '2 month', 'description': 'Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology'}], 'secondaryOutcomes': [{'measure': 'Identified profiles of children who do match between the two diagnostics methods', 'timeFrame': '2 month', 'description': 'Identified profiles of children who do match between the two diagnostics methods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Antromopemtric data', 'Pediatry'], 'conditions': ['Undernutrition']}, 'descriptionModule': {'briefSummary': "Undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.\n\nUntil now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. So, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team.\n\nSince November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has suggested recommendations to standardize pediatric undernutrition diagnosis.\n\nThe investigators offer to evaluate undernutrition prevalence differences diagnosed according to new HAS criteria compared to the previous diagnostic methodology.\n\nThe investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.", 'detailedDescription': 'The investigators will conduct a prospective cohort without change in care.\n\nFollowing classic patient admission in involved departments, the investigating team moves to the department to collect data.\n\nThe measurements and informations collected are no different from those taken in the context of normal care.\n\nAll anthropometric measurements correspond to recommendations of good practice. Anthropometric measurements will be carried out by the healthcare team.\n\nWith collected data the investigators will evaluate undernutrition for each child, according to the 2 diagnostics methods.\n\nFor any diagnosis of undernutrition, the department dietician will be alerted so that the patient can be taken care of so it is done normally.\n\nData collected are as follows:\n\nSimple demographic characteristics: Age, sex, departmentsand principal diagnosis Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date of term of pregnancy. Clinical history: all pathologies or clinical events that may be related to a weight variation.\n\nAssessment of ingesta. A non-opposition will be asked'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children under 18 admitted for hospitalization in the pediatric deparment of the Montpellier University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient under 18 years old (HAS 2019)\n* Patient admitted to short and long-stay pediatric services at Montpellier University Hospital, other than maternity, neonatal, palliative care or resuscitation and rehabilitation department.\n\nExclusion criteria:\n\n* Parental or child opposition\n* Legal guardian unable to express consent'}, 'identificationModule': {'nctId': 'NCT04482218', 'acronym': 'EDEN', 'briefTitle': 'Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations', 'orgStudyIdInfo': {'id': 'RECHMPL20_0391'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Antoine AVIGNON, PR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}