Paediatric traumatic brain injury Nervous System Diseases Brain injury
Conditions
Interventions
Group one: Hypothermia therapy, oesophageal temperature (32 - 33ºC)
Group two: Normothermia, oesophageal temperature (36.5 - 37.5ºC)
Duration: 24 hours
Sponsors
Children?s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent by a parent or legal guardian 2. Aged one year up to and including 17 years, either sex, with diagnosis of traumatic brain injury 3. Have a Glasgow Coma Score less than or equal to eight (severe traumatic brain injury according to the recent guidelines assessed at the tertiary level paediatric hospital 4. With a Computed Tomography (CT) scan showing intra-cranial haemorrhage, diffuse axonal injury or cerebral oedema 5. Who are mechanically ventilated
Exclusion criteria
Exclusion criteria: 1. Who are in refractory shock defined as a hypotension despite intravenous colloid and red cell transfusions exceeding 80 cc/kg 2. With a suspected diagnosis of clinical brain death as defined as fixed and dilated pupils, Glasgow Coma Scale of three and no evidence of brain function on neurological examination 3. Who remain pulseless after arrival in the emergency department despite advanced cardiac life support including at least one dose of epinephrine 4. With high cervical (C1 to C5) cord injury 5. With a severe neurodevelopmental disability (Paediatric Cerebral Performance Category scores (see primary outcome) prior to head injury 6. Who have head injury secondary to a penetrating injury (e.g. gunshot wound) 7. Who have an acute epidural haematoma and are expected to recover rapidly following surgical evacuation of the haematoma 8. Who are randomised (and initiation of cooling for patients randomised to hypothermia) more than eight hours following the estimated time of injury 9. Who are pregnant (diagnosed by serum Human Chorionic Gonadotropin [HCG]) 10. Whose parents/legal guardian refuse consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Paediatric Cerebral Performance Category (PCPC) score, six months post head injury. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of children achieving independent function, measured at one, three and 12 months post-head injury 2. Paediatric Injury Functional Outcome Score (IFOS), King's outcome score for childhood head injury, Glasgow Outcome Scale (GOS), GOS-expanded for children and adolescents, measured at one, three and 12 months post-head injury 3. Intelligence quotient, memory, speed of processing and attention, distractibility and behavioural rating scores, measured at three and 12 months post-head injury 4. Measures of cerebral physiology, complication rates and lengths of intensive care unit and hospital stay, during acute hospital stay | — |
Countries
Canada, France, United Kingdom
Outcome results
None listed