The TOBY Children Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01092637
First received: March 23, 2010
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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
Cerebral Palsy
Hypoxia-Ischemia, Brain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: School Age Outcomes Following a Newborn Cooling Trial

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Survival with an IQ > 84 [ Time Frame: Age between 6 years - 7 years 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 239
Study Start Date: September 2009
Estimated Study Completion Date: July 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
  Eligibility

Ages Eligible for Study:   72 Months to 87 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092637

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

Additional Information:
No publications provided by Imperial College London

Additional 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
Study First Received: March 23, 2010
Last Updated: November 26, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Cerebral Palsy
Brain Ischemia
Hypoxia-Ischemia, Brain
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain

ClinicalTrials.gov processed this record on September 16, 2014