Encephalopathy, Perinatal Asphyxia
Conditions
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.
Interventions
DRUGXenon
Inhaled xenon gas given via purposely designed ventilator
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 3 Years
Inclusion criteria
Surviving participants in the TOBY Xenon study
Exclusion criteria
Lack of consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Classification System | At 2-3 years of age | Levels 1-5 with higher levels indicating worse neuromotor function |
| Optimality Scores on Hammersmith neurological examination | At 2-3 years of age | Range of score is 0-78 with lower scores indicating more abnormal examination |
| Manual Ability Classification System | At 2-3 years of age | Levels 1-5 with higher levels indicating increasing difficulty in handling objects |
| Clinical signs of cerebral palsy | At 2-3 years of age | Defined according to Surveillance of Cerebral Palsy in Europe classification. |
Countries
United Kingdom
Outcome results
None listed