Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-03-15 @ 3:25 PM
Study NCT ID:
NCT06470932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life at 3 months', 'timeFrame': '3 months', 'description': 'Quality of life at 3 months measured by PEDS QL (Pediatric Quality of Life) scale, scoring from 0 (good quality of life) to 92 (poor quality of life)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Respiratory Diseases']}, 'descriptionModule': {'briefSummary': "This study aims to assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted in the PICU of Grenoble-Alps University Hospital\n* for acute respiratory failure (code J960) requiring mechanical ventilation for at least 48hrs\n\nExclusion Criteria:\n\n* already followed-up by a pediatric pulmonologist\n* with congenital disease\n* with long term ventilation\n* still admitted at 3 months'}, 'identificationModule': {'nctId': 'NCT06470932', 'briefTitle': 'Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure', 'orgStudyIdInfo': {'id': '38RC23.0449'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Follow up', 'interventionNames': ['Diagnostic Test: Follow-up consult']}], 'interventions': [{'name': 'Follow-up consult', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be ask to participate to a follow-up consult', 'armGroupLabels': ['Follow up']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guillaume Mortamet, MD PhD', 'role': 'CONTACT', 'email': 'gmortamet@chu-grenoble.fr', 'phone': '+33681521415'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'EssaiClinique_SUIVIRA', 'investigatorAffiliation': 'University Hospital, Grenoble'}}}}