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The TOBY Children Study

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ClinicalTrials.gov Identifier: NCT01092637
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : January 21, 2016
Last Update Posted : January 21, 2016
Sponsor:
Collaborator:
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

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
U.S. FDA Resources

Group/Cohort
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



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

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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.

Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01092637


Locations
United Kingdom
Imperial College London
London, United Kingdom
Sponsors and Collaborators
Imperial College London
University of Oxford
Investigators
Principal Investigator: Denis Azzopardi, MD FRCPCH Imperial College London

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01092637     History of Changes
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:
Ischemia
Cerebral Palsy
Hypoxia
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain