The TOBY Children Study

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

University of Oxford

Information provided by:

Imperial College London

ClinicalTrials.gov Identifier:

NCT01092637

First received: March 23, 2010

Last updated: NA

Last verified: March 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 23, 2010
Last Updated Date	March 23, 2010
Start Date ^ICMJE	September 2009
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 23, 2010)	The frequency of survival with an IQ > 84 [ Time Frame: Age between 6 years - 7 years 4 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The TOBY Children Study
Official Title ^ICMJE	School Age Outcomes Following a Newborn Cooling Trial
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	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Cerebral Palsy Hypoxia-Ischemia, Brain
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Cooled Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth Non-cooled Child was allocated standard intensive care only within 6 hours of birth
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	233
Estimated Completion Date	August 2013
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: participant in the TOBY Study Exclusion Criteria: previously documented instruction not to approach for inclusion in further TOBY projects
Gender	Both
Ages	72 Months to 88 Months
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01092637
Other Study ID Numbers ^ICMJE	ISRCTN89547571(2), G0801320
Has Data Monitoring Committee	No
Responsible Party	Chief Investigator: Dr Denis Azzopardi, Imperial College London
Study Sponsor ^ICMJE	Imperial College London
Collaborators ^ICMJE	University of Oxford
Investigators ^ICMJE	Not Provided
Information Provided By	Imperial College London
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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