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| ID | Type | Description | Link |
|---|---|---|---|
| G0801320 | Other Grant/Funding Number | Medical Research Council (UK) |
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| Name | Class |
|---|---|
| University of Oxford | OTHER |
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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.
Assessment tools used:
Neurological examination by paediatrician
Questionnaire data from parents/guardians and teachers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Survivors With an IQ > 84 | IQ was measured using WPPSI III core tests | 7 years 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Survivors Without Disability | IQ =>85, no neurological abnormalities, normal hearing, normal vision | 7 years 3 months |
| Number of Survivors With Cerebral Palsy | Number of participants diagnosed with Cerebral Palsy |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Denis Azzopardi, MD FRCPCH | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25006720 | Result | 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. | |
| 29997167 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cooled | Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth. Cooling lasted for 72 hours then gradually rewarmed, after which normothermia was maintained. Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study. Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire. Psychologist completed the following tests:
Assessors were blinded to original trial treatment allocation. |
| FG001 | Non-cooled | Child was allocated standard intensive care only within 6 hours of birth. Normothermia was maintained throughout. Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study. Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire. Psychologist completed the following tests:
Assessors were blinded to original trial treatment allocation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
96 children died before school age assessment could take place. 184 children were included in the 6-7 year follow-up study, 98 cooled and 86 non-cooled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cooled | Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth |
| BG001 | Non-cooled | Child was allocated standard intensive care only within 6 hours of birth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Survivors With an IQ > 84 | IQ was measured using WPPSI III core tests | Children for whom IQ data at age 6-7 yr were available | Posted | Number | participants | 7 years 3 months |
|
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Serious and other adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cooled | Allocated cooling treatment at randomization to original trial. See full description in Participant flow section. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Unit | National Perinatal Epidemiology Unit, University of Oxford | +44 1865 289700 | ctu@npeu.ox.ac.uk |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 7 years 3 months |
| 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. |
| 29510998 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Survivors Without Disability | IQ =>85, no neurological abnormalities, normal hearing, normal vision | Number of participants without disability. Two particpants in the cooled group and three in the non-cooled group could not be classified. | Posted | Number | participants | 7 years 3 months |
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|
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| Secondary | Number of Survivors With Cerebral Palsy | Number of participants diagnosed with Cerebral Palsy | Number of participants with cerebral palsy | Posted | Number | participants | 7 years 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Non-cooled | Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section. | 0 | 0 | 0 | 0 |
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| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |