The TOBY Children Study

NCT01092637 | Completed Results

• 2 other identifiers: ISRCTN89547571G0801320
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Hypoxia-Ischemia, Brain

Outcome Measures

Primary Outcomes (1)

• Number of Survivors With an IQ > 84

  IQ was measured using WPPSI III core tests

  7 years 3 months

Secondary Outcomes (2)

• Number of Survivors Without Disability

  7 years 3 months

• Number of Survivors With Cerebral Palsy

  7 years 3 months

Study Arms (2)

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

Eligibility Criteria

• Age: 72 Months - 87 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• participant in the TOBY Study

Sponsors & Collaborators

• Imperial College London: lead
• University of Oxford: collaborator

Study Sites (1)

Imperial College London

London, United Kingdom

Location

Related Publications (3)

• 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 on childhood outcomes. N Engl J Med. 2014 Jul 10;371(2):140-9. doi: 10.1056/NEJMoa1315788.

  PMID: 25006720 RESULT

• Rivero-Arias O, Eddama O, Azzopardi D, Edwards AD, Strohm B, Campbell H. Hypothermia for perinatal asphyxia: trial-based resource use and costs at 6-7 years. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F285-F292. doi: 10.1136/archdischild-2017-314685. Epub 2018 Jul 11.

  PMID: 29997167 DERIVED

• Campbell H, Eddama O, Azzopardi D, Edwards AD, Strohm B, Rivero-Arias O. Hypothermia for perinatal asphyxia: trial-based quality of life at 6-7 years. Arch Dis Child. 2018 Jul;103(7):654-659. doi: 10.1136/archdischild-2017-313733. Epub 2018 Mar 6.

  PMID: 29510998 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Cerebrovascular Disorders; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trials Unit
• Organization: National Perinatal Epidemiology Unit, University of Oxford

ctu@npeu.ox.ac.uk

+44 1865 289700

Study Officials

• Denis Azzopardi, MD FRCPCH

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: July 1, 2014
• Last Updated: January 21, 2016
• Results First Posted: January 21, 2016

Record last verified: 2013-11

Locations

GB (1)