Li 2009.
| Methods | Randomised controlled trial, parallel group | |
| Participants |
Total number of participants: 22 Baseline characteristics: Therapeutic cooling Age: 8 to 96 months GCS on admission: 6.4 (SD 1.8) Type of injury (closed/open): not stated No cooling Age: 6 to 108 months GCS on admission: 6.5 (SD 1.7) Type of injury (closed/open): not stated Inclusion criteria: children of both genders (6 to 108 months of age) with GCS ≤ 8 Exclusion criteria: Other serious accompanying injuries, history of neurological conditions and/or chronic disease states Country: China Setting: children's hospital |
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| Interventions |
Therapeutic cooling Number of participants: 12 Method of cooling: cooling cap Target temperature: 34.5 (± 0.2) ºC Time of cooling: average time taken before initiation of treatment 7.2 (± 1.4) hours after injury Duration of cooling: 72 hours Rewarming details: no details Site of temperature measurement: intracranial No cooling Number of participants: 10 Target temperature: intracranial temperatures were 37.5 to 38.5 ºC |
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| Outcomes | Outcomes measured in study: mortality, heart rate, blood pressure, pH and electrolyte levels, ICP, cerebrospinal fluid, biochemical markers | |
| Notes |
Funding/declarations of interest: supported by grant, no conflicting financial interests declared Study dates: January 2006 to August 2007 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "The patients were divided randomly into a moderate hypothermia group (HYPO group; n = 12) and a normothermia group (NORM group; n = 10) on the basis of arrival date (odd number = HYPO; even number = NORM)" Unacceptable randomisation |
| Allocation concealment (selection bias) | Unclear risk | It is unclear whether study investigators revealed randomisation code (odd/even arrival date) to personnel and whether this method of randomisation was conducted externally |
| Blinding of participants and personnel (performance bias): mortality | Low risk | Lack of blinding unlikely to influence performance for this outcome |
| Blinding of outcome assessment (detection bias): mortality; pneumonia | Low risk | No details; lack of outcome assessor blinding is unlikely to influence outcome data |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or pre‐published protocol not reported. Insufficient information to make judgement |
| Other bias | Low risk | No other sources of bias identified |