Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05721105
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2023-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-01-31', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the overall quality of life of children aged 0-10 years supported by ECMO during their intensive care period with a population of children of the same age hospitalized in pediatric intensive care in the same period.', 'timeFrame': '15 days', 'description': 'Quality of life evaluated by the total score of the PedsQL (Pediatric Quality of Life InventoryTM), scale from 0 to 4; 4 being the worst outcome.'}], 'secondaryOutcomes': [{'measure': 'To compare the different QoL dimensions of children supported by ECMO between 0 and 10 years of age during their intensive care with reference to a population of children of the same age hospitalized in pediatric intensive care during the same period', 'timeFrame': 'up to 15 days', 'description': 'PedsQL (Pediatric Quality of Life Questionnaire) : Physical functioning, emotional functioning, social functioning, academic functioning.\n\nPedsQL (Pediatric Quality of Life Questionnaire), scale from 0 to 4; 4 being the worst outcome.'}, {'measure': 'To compare the different QoL dimensions of children supported by ECMO between 0 and 10 years of age during their intensive care stay to a reference consisting of healthy children, not hospitalized, studied over the same period and in the same country', 'timeFrame': 'up to 15 days', 'description': 'PedsQL Questionnaire scores of a cohort of healthy children of the same age from the literature.\n\nPedsQL (Pediatric Quality of Life InventoryTM), scale from 0 to 4; 4 being the worst outcome.'}, {'measure': 'Describe the association between neurological complications and their severity (seizures, clinical deficits, imaging lesions) and QoL in patients supported by ECMO.', 'timeFrame': 'up to 15 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Intensive Care', 'Quality of life'], 'conditions': ['Extracorporeal Membrane Oxygenation Complication', 'Critical Care']}, 'descriptionModule': {'briefSummary': 'The main objective of this prospective transversal comparative study is to describe the quality of life of children supported by ECMO. These patients are described in detail at the Nantes University Hospital, in particular the elements of neurological monitoring. These results will be analyzed in reference to a population hospitalized at the same age, in the same period, and sharing the same diagnostic categories.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients included (ECMO group) will be patients under 10 years of age treated by ECMO at the University Hospital of Nantes from January 2014 to December 2022 and who have reached the age of 2 years during the study (the hetero-evaluation questionnaires for the primary endpoint being validated from this age).\n\nThe controls will be patients hospitalized at the same age in pediatric intensive care and at the same periods, who have been intubated and ventilated for at least 48 hours, and/or who have received amines and/or who have benefited from organ support other than ECMO (CONTROL group).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients accepted in pediatric intensive care at the Nantes University Hospital between January 2014 and December 2022\n* Patients less than 10 years old at admission to the intensive care unit,\n* Patients older than 2 years at the time of the cross-sectional evaluation\n* For the ECMO group: Patients supported by ECMO\n* For the control group: Patient intubated-ventilated for more than 48 hours and/or having received amines and/or having received organ support other than ECMO.\n* Patient affiliated to the Social Security.\n* Patient with parents who do not object to the study\n\nExclusion Criteria:\n\n* Known genetic pathology or malformative association at the time of admission to the intensive care unit that could lead to severe neurodevelopmental deficits, independently of the medical events that resulted in the admission to the intensive care unit\n* Language difficulty that does not allow for complete information and questionnaire collection'}, 'identificationModule': {'nctId': 'NCT05721105', 'acronym': 'ECMOQoL', 'briefTitle': 'Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO): a Prospective Transversal Study', 'orgStudyIdInfo': {'id': 'RC23_0013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECMO', 'description': '50 Patients admitted to pediatric intensive care at the University Hospital of Nantes between January 2014 and December 2022 and supported by ECMO during their hospitalization.', 'interventionNames': ['Other: Quality of life assessment using questionnaires']}, {'label': 'Control', 'description': '50 patients hospitalized at the same age, during the same time period, and sharing the same diagnostic categories as the ECMO group, but the control group never had ECMO.', 'interventionNames': ['Other: Quality of life assessment using questionnaires']}], 'interventions': [{'name': 'Quality of life assessment using questionnaires', 'type': 'OTHER', 'description': 'Several quality of life questionnaires will be submitted to the patients and their parents. The questionnaires will be adapted to the age of the patients.', 'armGroupLabels': ['Control', 'ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}