This trial is active, not recruiting.

Conditions cerebral palsy, hypoxia-ischemia, brain
Sponsor Imperial College London
Collaborator University of Oxford
Start date September 2009
End date August 2013
Trial size 239 participants
Trial identifier NCT01092637, G0801320, ISRCTN89547571


The aim of this study is to determine the efficacy 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. This study will determine whether the apparent initial benefits of cooling are maintained in the longer term.

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 participated 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 84, the presence and severity of disabilities, educational attainment and the economic impact on families and service providers. If possible, children will be assessed in their school, with the option of alternative venues such as home or clinic if required.

During the assessment a paediatrician will conduct a neurological examination. A psychologist will administer psychometric tests to evaluate cognitive, behavioural and motor development. Questionnaires completed by parents and teachers will complete the data collection. Economic factors will also be assessed in the parent questionnaire.

Each child will have contact with the assessors during one school day with appropriate breaks. Assessments will take place over a period of 3 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth
Child was allocated standard intensive care only within 6 hours of birth

Primary Outcomes

Survival with an IQ > 84
time frame: Age between 6 years - 7 years 3 months

Eligibility Criteria

Male or female participants from 72 months up to 87 months old.

Inclusion Criteria: - participant in the TOBY Study Exclusion Criteria: - previously documented instruction not to approach for inclusion in further TOBY projects

Additional Information

Official title School Age Outcomes Following a Newborn Cooling Trial
Principal investigator Denis Azzopardi
Description - Assessment tools used: - Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III; 2004) or Wechsler Intelligence Scales for Children - NEPSY Second Edition - Working Memory Test Battery for Children - Neurological examination by paediatrician - Questionnaire data from parents/guardians and teachers
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Imperial College London.