Study Results
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View full resultsBasic Information
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COMPLETED
280 participants
OBSERVATIONAL
2009-09-30
2014-07-31
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Cooled
Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth
No interventions assigned to this group
Non-cooled
Child was allocated standard intensive care only within 6 hours of birth
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
72 Months
87 Months
ALL
No
Sponsors
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University of Oxford
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Denis Azzopardi, MD FRCPCH
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College London
London, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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G0801320
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ISRCTN89547571
Identifier Type: -
Identifier Source: org_study_id
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