Outcome After 24 Months of Participants in the TOBY Xenon Study
Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia
1 other identifier
observational
69
1 country
3
Brief Summary
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2014
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 14, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedMay 30, 2019
May 1, 2019
2.8 years
May 14, 2019
May 28, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Scores on Bayley scales of infant and toddler development
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
at 2-3 years of age
Relation between magnetic resonance markers and neurodevelopmental outcome
Peak area Lactate/N Acetyl Aspartate ratio on magnetic resonance spectroscopy and fractional anisotropy on diffusion tensor magnetic resonance imaging
at 2-3 years of age
Secondary Outcomes (1)
Grade of disability
At 2-3 years of age
Other Outcomes (4)
Optimality Scores on Hammersmith neurological examination
At 2-3 years of age
Gross Motor Function Classification System
At 2-3 years of age
Manual Ability Classification System
At 2-3 years of age
- +1 more other outcomes
Study Arms (2)
Standard care with moderate hypothermia
Surviving children allocated to standard care with moderate hypothermia in the TOBY-Xe trial
30% Xenon for 24 hours combined with moderate hypothermia
Surviving children allocated to inhaled xenon combined with moderate hypothermia in the TOBY-Xe trial
Interventions
Inhaled xenon gas given via purposely designed ventilator
Eligibility Criteria
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
You may qualify if:
- Surviving participants in the TOBY Xenon study
You may not qualify if:
- Lack of consent to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Edwards, FMedSci
King's College London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2019
First Posted
May 30, 2019
Study Start
August 1, 2014
Primary Completion
June 1, 2017
Study Completion
May 1, 2018
Last Updated
May 30, 2019
Record last verified: 2019-05