Cerebral Palsy, Hypoxia-Ischemia, Brain
Conditions
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.
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
Interventions
None listed
Sponsors
University of Oxford
Imperial College London
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
72 Months to 87 Months
Healthy volunteers
No
Inclusion criteria
* participant in the TOBY Study
Exclusion criteria
* previously documented instruction not to approach for inclusion in further TOBY projects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Survivors With an IQ > 84 | 7 years 3 months | IQ was measured using WPPSI III core tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Survivors Without Disability | 7 years 3 months | IQ =\>85, no neurological abnormalities, normal hearing, normal vision |
| Number of Survivors With Cerebral Palsy | 7 years 3 months | Number of participants diagnosed with Cerebral Palsy |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cooled Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth | 145 |
| Non-cooled Child was allocated standard intensive care only within 6 hours of birth | 135 |
| Total | 280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 47 | 49 |
Baseline characteristics
| Characteristic | Cooled | Non-cooled | Total |
|---|---|---|---|
| Age, Continuous | 6.27 years | 6.24 years | 6.25 years |
| Sex: Female, Male Female | 54 Participants | 61 Participants | 115 Participants |
| Sex: Female, Male Male | 91 Participants | 74 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Survivors With an IQ > 84
IQ was measured using WPPSI III core tests
Time frame: 7 years 3 months
Population: Children for whom IQ data at age 6-7 yr were available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cooled | Number of Survivors With an IQ > 84 | 75 participants |
| Non-cooled | Number of Survivors With an IQ > 84 | 52 participants |
Secondary
Number of Survivors With Cerebral Palsy
Number of participants diagnosed with Cerebral Palsy
Time frame: 7 years 3 months
Population: Number of participants with cerebral palsy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cooled | Number of Survivors With Cerebral Palsy | 21 participants |
| Non-cooled | Number of Survivors With Cerebral Palsy | 31 participants |
Secondary
Number of Survivors Without Disability
IQ =\>85, no neurological abnormalities, normal hearing, normal vision
Time frame: 7 years 3 months
Population: Number of participants without disability. Two particpants in the cooled group and three in the non-cooled group could not be classified.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cooled | Number of Survivors Without Disability | 65 participants |
| Non-cooled | Number of Survivors Without Disability | 37 participants |