The TOBY Children Study

December 15, 2015 updated by: Imperial College London

School Age Outcomes Following a Newborn Cooling Trial

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • participant in the TOBY Study

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Survivors With an IQ > 84
Time Frame: 7 years 3 months
IQ was measured using WPPSI III core tests
7 years 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Survivors Without Disability
Time Frame: 7 years 3 months
IQ =>85, no neurological abnormalities, normal hearing, normal vision
7 years 3 months
Number of Survivors With Cerebral Palsy
Time Frame: 7 years 3 months
Number of participants diagnosed with Cerebral Palsy
7 years 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

University of Oxford

Investigators

  • Principal Investigator: Denis Azzopardi, MD FRCPCH, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

December 15, 2015

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISRCTN89547571
  • G0801320 (Other Grant/Funding Number: Medical Research Council (UK))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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