Outcome After 24 Months of Participants in the TOBY Xenon Study
NCT ID: NCT03968861
Last Updated: 2019-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
69 participants
OBSERVATIONAL
2014-08-31
2018-05-31
Brief Summary
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Continuing 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard care with moderate hypothermia
Surviving children allocated to standard care with moderate hypothermia in the TOBY-Xe trial
No interventions assigned to this group
30% Xenon for 24 hours combined with moderate hypothermia
Surviving children allocated to inhaled xenon combined with moderate hypothermia in the TOBY-Xe trial
Xenon
Inhaled xenon gas given via purposely designed ventilator
Interventions
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Xenon
Inhaled xenon gas given via purposely designed ventilator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
3 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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David A Edwards, FMedSci
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Guys and St Thomas NHS Trust
London, , United Kingdom
Imperial College London NHS Healthcare Trust
London, , United Kingdom
University College London Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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IRAS157755
Identifier Type: -
Identifier Source: org_study_id
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