Outcome After 24 Months of Participants in the TOBY Xenon Study
- Registration Number
- NCT03968861
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Surviving participants in the TOBY Xenon study
Lack of consent to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 30% Xenon for 24 hours combined with moderate hypothermia Xenon Surviving children allocated to inhaled xenon combined with moderate hypothermia in the TOBY-Xe trial
- Primary Outcome Measures
Name Time Method Scores on Bayley scales of infant and toddler development at 2-3 years of age 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
Relation between magnetic resonance markers and neurodevelopmental outcome at 2-3 years of age Peak area Lactate/N Acetyl Aspartate ratio on magnetic resonance spectroscopy and fractional anisotropy on diffusion tensor magnetic resonance imaging
- Secondary Outcome Measures
Name Time Method Grade of disability At 2-3 years of age 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).
Trial Locations
- Locations (3)
Guys and St Thomas NHS Trust
🇬🇧London, United Kingdom
University College London Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Imperial College London NHS Healthcare Trust
🇬🇧London, United Kingdom