The TOBY Children Study

Cerebral Palsy Clinical Trial

Official title:

School Age Outcomes Following a Newborn Cooling Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092637
• Other study ID #: ISRCTN89547571
• Secondary ID: G0801320
• Status: Completed
• Phase: N/A
• First received: March 23, 2010
• Last updated: December 15, 2015
• Start date: September 2009
• Est. completion date: July 2014

Study information

• Verified date: November 2013
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: July 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 72 Months to 87 Months

Eligibility

Inclusion Criteria:

• participant in the TOBY Study

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Palsy
• Hypoxia-Ischemia, Brain

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Azzopardi D, Strohm B, Marlow N, Brocklehurst P, Deierl A, Eddama O, Goodwin J, Halliday HL, Juszczak E, Kapellou O, Levene M, Linsell L, Omar O, Thoresen M, Tusor N, Whitelaw A, Edwards AD; TOBY Study Group. Effects of hypothermia for perinatal asphyxia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Survivors With an IQ > 84	IQ was measured using WPPSI III core tests	7 years 3 months	No
Secondary	Number of Survivors Without Disability	IQ =>85, no neurological abnormalities, normal hearing, normal vision	7 years 3 months	No
Secondary	Number of Survivors With Cerebral Palsy	Number of participants diagnosed with Cerebral Palsy	7 years 3 months	No

External Links

•   TOBY Children Study home page, with access to the Study Protocol, information leaflets, newsletters and contact details.