The TOBY Children Study
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| ClinicalTrials.gov Identifier: NCT01092637 |
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Recruitment Status :
Completed
First Posted : March 25, 2010
Results First Posted : January 21, 2016
Last Update Posted : January 21, 2016
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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.
| Condition or disease |
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| Cerebral Palsy Hypoxia-Ischemia, Brain |
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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
| Study Type : | Observational |
| Actual Enrollment : | 280 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | School Age Outcomes Following a Newborn Cooling Trial |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | July 2014 |
| Group/Cohort |
|---|
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Cooled
Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth
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Non-cooled
Child was allocated standard intensive care only within 6 hours of birth
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- Number of Survivors With an IQ > 84 [ Time Frame: 7 years 3 months ]IQ was measured using WPPSI III core tests
- Number of Survivors Without Disability [ Time Frame: 7 years 3 months ]IQ =>85, no neurological abnormalities, normal hearing, normal vision
- Number of Survivors With Cerebral Palsy [ Time Frame: 7 years 3 months ]Number of participants diagnosed with Cerebral Palsy
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| Ages Eligible for Study: | 72 Months to 87 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- participant in the TOBY Study
Exclusion Criteria:
- previously documented instruction not to approach for inclusion in further TOBY projects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092637
| United Kingdom | |
| Imperial College London | |
| London, United Kingdom | |
| Principal Investigator: | Denis Azzopardi, MD FRCPCH | Imperial College London |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01092637 |
| Other Study ID Numbers: |
ISRCTN89547571 G0801320 ( Other Grant/Funding Number: Medical Research Council (UK) ) |
| First Posted: | March 25, 2010 Key Record Dates |
| Results First Posted: | January 21, 2016 |
| Last Update Posted: | January 21, 2016 |
| Last Verified: | November 2013 |
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Cerebral Palsy Brain Ischemia Hypoxia-Ischemia, Brain Ischemia Hypoxia Pathologic Processes Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Signs and Symptoms, Respiratory Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Hypoxia, Brain |