The TOBY Children Study

10 July 2014

The TOBY Children Study results have now been published in the New England Journal of Medicine:

Reference:
Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes. Azzopardi D, Strohm B, Marlow N, Brocklehurst P, Deierl A, Eddama O, Goodwin J, Halliday H, Juszczak E, Kapellou O, Levene M, Linsell L, Omar O, Thoresen M, Tusor N, Whitelaw A, Edwards AD for the TOBY Study Group NEJM 2014; 371:140-9. DOI: 10.1056/NEJMoa1315788

The Medical Research Council funded this school-age follow-up study of the participants of the TOBY Trial, in order to find out whether the benefits of cooling that were apparent at 18 months have been maintained in the longer term.

View TOBY Children Study Results - Parents Newsletter July 2014

View the NEJM TOBY Children Study Results paper abstract

The UK Medical Research Council (MRC), who had funded the TOBY Study (see the TOBY Study web pages), has provided further funding to allow assessment of TOBY Children at age 6-7 years. This is a 4-year project, from 2009 - 2013. The Charing Cross Hospital Research Ethics Committee has granted ethical approval; the first families were invited to allow their child to participate in March 2010.

At 6-7 years of age, children’s health and development can be assessed in much greater detail than is possible during infancy. By collecting more detailed information we can find out whether the benefits of cooling that were apparent at 18 months are maintained in the longer term. Difficulties that were present at 18 months may have gone away by school age but it is also possible that other issues that could not be identified at 18 months may appear as the child grows up. It is important for us to know this, as it may become necessary to change current treatment as a result of this follow-up study.

Aim

The TOBY Study was a randomised controlled trial of whole body hypothermia for the treatment of perinatal asphyxial encephalopathy. The aim of this Study is to determine the effect of therapeutic hypothermia following perinatal asphyxia on neurological and neuropsychological outcomes and also to assess academic attainment and any additional health, societal or educational costs associated with changes in outcome as a result of the intervention.

Assessment

The assessment will capture areas of neurological, sensory, cognitive, memory, attention and executive function which represent areas likely to be affected by perinatal asphyxia. Parents will be asked to complete questionnaires which will cover the areas of behaviour, everyday memory, health care usage and demographic information. Teachers will be asked to complete a questionnaire to evaluate educational attainment and behaviour.

Eligibility criteria

Participation in the TOBY Study

Written informed parental consent

Primary outcome

Frequency of survival with an IQ ? 85
(an IQ of 85 is 1 standard deviation below the standardised mean IQ of normal children).

Secondary outcomes

Overall IQ (WPPSI III); Verbal sub scores (WPPSI III) [UK speaking children]; Speeded naming (WPPSI III); Overall WMTB-C Scale; Overall SDQ score for behavioural problems; Overall ADHD Score (Du Paul); Prevalence and type of Cerebral Palsy; Overall grade of disability (impairment/mild/moderate/severe); Teachers academic achievement score; Attainment on National Educational Tests at Key Stage 1 (UK children only); Health Economic evaluation: Health related quality of life (Health utility scores HUI-3); Overall number of deaths in each group to age 7y 4m.

ISRCTN:
89547571
Funded by:
UK Medical Research Council
Sponsor:
Imperial College London
MREC number:
10/H0711/13
Clinical Trials.gov Identifier:
NCT00147030