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The TOBY Children Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01092637
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : January 21, 2016
Last Update Posted : January 21, 2016
University of Oxford
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease
Cerebral Palsy Hypoxia-Ischemia, Brain

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

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 Outcome Measures :
  1. Number of Survivors With an IQ > 84 [ Time Frame: 7 years 3 months ]
    IQ was measured using WPPSI III core tests

Secondary Outcome Measures :
  1. Number of Survivors Without Disability [ Time Frame: 7 years 3 months ]
    IQ =>85, no neurological abnormalities, normal hearing, normal vision

  2. Number of Survivors With Cerebral Palsy [ Time Frame: 7 years 3 months ]
    Number of participants diagnosed with Cerebral Palsy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
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.


Inclusion Criteria:

  • participant in the TOBY Study

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01092637

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United Kingdom
Imperial College London
London, United Kingdom
Sponsors and Collaborators
Imperial College London
University of Oxford
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Principal Investigator: Denis Azzopardi, MD FRCPCH Imperial College London
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Imperial College London 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
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Ischemia
Hypoxia-Ischemia, Brain
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