Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT04798794
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2021-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCO2 ELSO (Extracorporeal Life Support Organization)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015199', 'term': 'Extracorporeal Membrane Oxygenation'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4072}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Neurological Event', 'timeFrame': 'Up to 90 days after ECMO initiation', 'description': 'Onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death. The outcome (ANE) was defined by the occurrence of almost one of the following item:\n\n* Ischemic or hemmorrhagic stroke diagnosed by ultrasounds, CT or MRI\n* Clinical or electrical seizures : diagnosed by ElectroEncepahloGraphy (EEG)\n* Brain death clinically diagnosed'}], 'secondaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 days after ECMO start', 'description': 'Newborns died after 28 days despite ECMO assistance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ecmo', 'Neonates'], 'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.', 'detailedDescription': 'Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates (\\<28 j) supported by ECMO for severe respiratory failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Support by ECMO for respiratory indication\n\nExclusion Criteria :\n\n* None'}, 'identificationModule': {'nctId': 'NCT04798794', 'briefTitle': 'PCO2 ELSO (Extracorporeal Life Support Organization)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns', 'orgStudyIdInfo': {'id': 'JS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ECMO for neonates', 'type': 'OTHER', 'description': 'Neonates (\\<28 j) supported by ECMO for severe respiratory failure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}