Outcome at School Age Following Treatment With Whole Body Hypothermia After Perinatal Asphyxial Encephalopathy

Perinatal asphyxia (a lack of oxygen occurring around the time of birth) may have long term consequences on brain functioning, which may be altered by treatment with hypothermia (cooling). Currently, there is no information on the effect of cooling on outcome beyond 18 months of age. We intend to assess at 6-7 years of age the children that partcipated in the TOBY trial of whole body cooling following perinatal asphyxia and compare between the children that had received the cooling treatment soon after birth and those that were not treated with cooling, the number that survived with an intelligence quotient (IQ) greater than 70, the presence and severity of disabilities, the parent and teacher reports on behaviour, performance at school and the results of brain scans. If this study confirms that treatment with cooling is safe and effective it will be adopted into clinical practice in the NHS since it is relatively simple and inexpensive to carry out. If it were shown not to be effective or to be harmful in the longer term, indiscriminate use of this treatment may need to be discouraged.

We intend to evaluate the neurological, neuropsychological function and educational attainment of participants of the TOBY trial at 6-7 years of age. The study will commence in September 2009 and continue for 48 months. We intend to use a series of neuropsychological tests and a formal neuromotor assessment to assess and classify disabilities. The primary outcome measure will be survival with an intelligence quotient (IQ) 70 or greater. Secondary outcomes will include scores on general cognitive and executive function tests, parent and teacher report behavioural measures, scholastic attainment, patterns of disabilities and the severity and pattern of abnormalities on magnetic resonance imaging (MRI). We will use standard statistical tests to look for significant differences in these measures between children in the cooled and control groups.