Chen 2006.
Methods | Randomised controlled trial. Conducted in paediatric hospital in China. 62 children enrolled (observation group = 32, control group = 30). Randomly split into study groups Dose of IVIG/placebo used: 400 mg/kg/day for 3‐5 days. Outcome assessment done during period of hospitalisation. |
|
Participants | Inclusion criteria
Exclusion criteria
|
|
Interventions | Control group: conventional treatment including fever and spasm reduction, reduction of intracranial pressure, maintenance of hydration, electrolyte and acid‐base balance, antiviral treatment, treatment of infections. Observation group: conventional treatment as above + IVIG 400 mg/kg/day continuously for 3‐5 days. |
|
Outcomes | Time for fever reduction. Time taken to stop further spasms. Time taken to regain consciousness. Duration of hospital stay. |
|
Notes | No information on ethical approval or informed consent. No information provided on funding. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random allocation but method of randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts and all participants were included in outcome assessment. |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available in public domain. |
Other bias | Unclear risk | Small sample size and no sample size calculation so unclear if sample size large enough to detect significant differences between study groups. No information on funding provided. |