Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT03701620
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2018-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Variability in Children With Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2018-10-03', 'studyFirstSubmitQcDate': '2018-10-08', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of the time with reliable HRVmonitoring in children with TBI', 'timeFrame': '1 year', 'description': 'Feasibility of having a reliable capture and analysis of HRV 7 days post TBI'}], 'secondaryOutcomes': [{'measure': 'Rate of adverse events preceded by a decreased HRV', 'timeFrame': '1 year', 'description': 'Adverse events will be defined as increased intracranial pressure, decreased CPP, seizure and cardiac arrest'}, {'measure': 'HRV and neurological outcome', 'timeFrame': '1.5 year', 'description': 'The primary outcome of neurological and functional outcome will be assessed by the Pediatric Glasgow Outcome Scale Extended (P-GOSE) 6 months post TBI. P-GOSE is an 8-point ordinal scale (1= best outcome) The score will be classified as favourable (P-GOSE 1 or 2, or decreased of P-GOSE of 1 point post PICU (∆ P-GOSE ≤1) or unfavourable (P-GOSE ≥3 or ∆ P-GOSE ≥2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury', 'Child Development']}, 'descriptionModule': {'briefSummary': 'Using a prospective cohort of children admitted to the PICU, the investigators will determine HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a tool that can predict adverse events (neurological crisis) within 2 days following TBI.', 'detailedDescription': 'This is a single center prospective cohort study of 15 children \\<18 years, admitted to the PICU at the CHU Sainte-Justine (CHUSJ) with moderate or severe TBI (\\<24 hours). Neurodevelopment outcome of children will be evaluated 6 months post TBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children requiring PICU admission after TBI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<18 years\n* admitted to the PICU at the CHUSJ\n* moderate TBI (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8) as - - assessed 30 minutes after TBI or upon arrival in the emergency room\n* written parental consent.\n\nExclusion Criteria:\n\n* children fulfilling brain death criteria at the time of PICU admission (GCS 3 and loss of all brain stem reflexes)\n* children with a pacemaker or with previously diagnosed arrhythmia (HRV monitoring not reliable)\n* inflicted trauma (different underlying pathophysiology)\n* patients or parents who do not speak or read English or French.'}, 'identificationModule': {'nctId': 'NCT03701620', 'acronym': 'HRV-TBI', 'briefTitle': 'Heart Rate Variability in Children With Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome', 'orgStudyIdInfo': {'id': 'HSJ 2018-1575'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HRV monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'HRV monitoring derived from electrocardiogram'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric intensivist, Principal Investigator', 'investigatorFullName': 'Laurence Ducharme-Crevier', 'investigatorAffiliation': "St. Justine's Hospital"}}}}