Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-01-01 @ 10:25 PM
Study NCT ID:
NCT03968861
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2019-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome After 24 Months of Participants in the TOBY Xenon Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014978', 'term': 'Xenon'}], 'ancestors': [{'id': 'D005741', 'term': 'Noble Gases'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Optimality Scores on Hammersmith neurological examination', 'timeFrame': 'At 2-3 years of age', 'description': 'Range of score is 0-78 with lower scores indicating more abnormal examination'}, {'measure': 'Gross Motor Function Classification System', 'timeFrame': 'At 2-3 years of age', 'description': 'Levels 1-5 with higher levels indicating worse neuromotor function'}, {'measure': 'Manual Ability Classification System', 'timeFrame': 'At 2-3 years of age', 'description': 'Levels 1-5 with higher levels indicating increasing difficulty in handling objects'}, {'measure': 'Clinical signs of cerebral palsy', 'timeFrame': 'At 2-3 years of age', 'description': 'Defined according to Surveillance of Cerebral Palsy in Europe classification.'}], 'primaryOutcomes': [{'measure': 'Scores on Bayley scales of infant and toddler development', 'timeFrame': 'at 2-3 years of age', 'description': 'Composite scores of the Cognitive, Language and Motor scales scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160'}, {'measure': 'Relation between magnetic resonance markers and neurodevelopmental outcome', 'timeFrame': 'at 2-3 years of age', 'description': 'Peak area Lactate/N Acetyl Aspartate ratio on magnetic resonance spectroscopy and fractional anisotropy on diffusion tensor magnetic resonance imaging'}], 'secondaryOutcomes': [{'measure': 'Grade of disability', 'timeFrame': 'At 2-3 years of age', 'description': 'The grade of disability, categorised as mild disability (a Cognitive score of 70 to 84, level 1 gross motor function \\[is able to walk independently but may have some gait abnormalities\\], or abnormality in one or both eyes with normal or nearly normal vision), moderate disability (a Cognitive scale score of 56 to 69, level 2 or 3 gross motor function \\[has minimal ability to perform gross motor skills or requires assistance with walking\\], or moderately reduced vision), or severe disability (a Cognitive scale score of 55 (the minimum score on the Bayley Cognitive scale), level 4 or 5 gross motor function \\[needs adaptive seating or has severely limited mobility\\], or no useful vision).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perinatal Asphyxia', 'Encephalopathy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to document the outcome at 2-3 years of age of participants of the TOBY Xe trial, to provide preliminary information about the later clinical effects of treatment with Xenon gas combined with moderate hypothermia following perinatal asphyxia. The TOBY Xe trial was a randomised controlled trial of inhaled xenon gas combined with hypothermia for the treatment of perinatal asphyxia. The trial primary outcome was changes on magnetic resonance parameters examined prior to discharge from hospital.\n\nContinuing clinical follow-up of trial participants is important following any therapeutic trial and is essential in early phase trials where information on the clinical effects of the intervention are lacking. Therefore, we have set up this study to determine the major clinical and neurological outcomes of participants of the TOBY Xe trial and to determine whether the magnetic resonance parameters in that trial are qualified to predict outcome following neural rescue therapy. This information is necessary for planning further studies of this intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population were the surviving participants in the TOBY Xenon study. There were 69 survivors from 92 participants at 2 years after birth and 62 of the 69 participants entered the TOBY Xenon Follow-up Study', 'eligibilityCriteria': 'Inclusion Criteria:\n\nSurviving participants in the TOBY Xenon study\n\nExclusion Criteria:\n\nLack of consent to participate'}, 'identificationModule': {'nctId': 'NCT03968861', 'briefTitle': 'Outcome After 24 Months of Participants in the TOBY Xenon Study', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia', 'orgStudyIdInfo': {'id': 'IRAS157755'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard care with moderate hypothermia', 'description': 'Surviving children allocated to standard care with moderate hypothermia in the TOBY-Xe trial'}, {'label': '30% Xenon for 24 hours combined with moderate hypothermia', 'description': 'Surviving children allocated to inhaled xenon combined with moderate hypothermia in the TOBY-Xe trial', 'interventionNames': ['Drug: Xenon']}], 'interventions': [{'name': 'Xenon', 'type': 'DRUG', 'otherNames': ['Lenoxe'], 'description': 'Inhaled xenon gas given via purposely designed ventilator', 'armGroupLabels': ['30% Xenon for 24 hours combined with moderate hypothermia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Guys and St Thomas NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College London NHS Healthcare Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'David A Edwards, FMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}