Clinical trial NCT01092637: The TOBY Children Study
Official title: School Age Outcomes Following a Newborn Cooling Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Hypoxia-Ischemia, Brain
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2010-03-25
Enrollment: 280
Sex: ALL
Minimum age (years): 72
Maximum age (years): 87
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants were recruited to the TOBY randomised controlled trial as newborns, with confirmed moderate or severe hypoxic ischaemic encephalopathy.

They were allocated either standard intensive care or standard intensive care plus moderate whole body hypothermia within 6 hours of birth.

Brief summary: 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* participant in the TOBY Study

Exclusion Criteria:

* previously documented instruction not to approach for inclusion in further TOBY projects

Primary outcomes:
measure: Number of Survivors With an IQ > 84
timeFrame: 7 years 3 months
Secondary outcomes:
measure: Number of Survivors Without Disability
timeFrame: 7 years 3 months
measure: Number of Survivors With Cerebral Palsy
timeFrame: 7 years 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: Denis Azzopardi, MD FRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azzopardi D, Strohm B, Marlow N, Brocklehurst P, Deierl A, Eddama O, Goodwin J, Halliday HL, Juszczak E, Kapellou O, Levene M, Linsell L, Omar O, Thoresen M, Tusor N, Whitelaw A, Edwards AD; TOBY Study Group. Effects of hypothermia for perinatal asphyxia on childhood outcomes. N Engl J Med. 2014 Jul 10;371(2):140-9. doi: 10.1056/NEJMoa1315788.
citation: Rivero-Arias O, Eddama O, Azzopardi D, Edwards AD, Strohm B, Campbell H. Hypothermia for perinatal asphyxia: trial-based resource use and costs at 6-7 years. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F285-F292. doi: 10.1136/archdischild-2017-314685. Epub 2018 Jul 11.
citation: Campbell H, Eddama O, Azzopardi D, Edwards AD, Strohm B, Rivero-Arias O. Hypothermia for perinatal asphyxia: trial-based quality of life at 6-7 years. Arch Dis Child. 2018 Jul;103(7):654-659. doi: 10.1136/archdischild-2017-313733. Epub 2018 Mar 6.