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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | Inhaled xenon gas given via purposely designed ventilator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of disability | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Optimality Scores on Hammersmith neurological examination | Range of score is 0-78 with lower scores indicating more abnormal examination | At 2-3 years of age |
| Gross Motor Function Classification System |
Inclusion Criteria:
Surviving participants in the TOBY Xenon study
Exclusion Criteria:
Lack of consent to participate
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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
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| Name | Affiliation | Role |
|---|---|---|
| David A Edwards, FMedSci | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys and St Thomas NHS Trust | London | United Kingdom | ||||
| Imperial College London NHS Healthcare Trust |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| At 2-3 years of age |
Levels 1-5 with higher levels indicating worse neuromotor function
| At 2-3 years of age |
| Manual Ability Classification System | Levels 1-5 with higher levels indicating increasing difficulty in handling objects | At 2-3 years of age |
| Clinical signs of cerebral palsy | Defined according to Surveillance of Cerebral Palsy in Europe classification. | At 2-3 years of age |
| London |
| United Kingdom |
| University College London Hospital NHS Foundation Trust | London | United Kingdom |