Methods | Study design: randomized controlled trial Study dates: February 1978 to May 1979 Diagnostics: clinical and serological or virological: Haemagluttinin Inhibition (HI) test on acute and convalescent paired sera, technique of Clarke and Casals. Virus isolation by mosquito inoculation, technique of Rose and Gubler for patients with a fourfold increase of the HI antibody titre or patients who died. |
|
Participants | Number of participants: randomized: 97 enrolled (47 in corticosteroid
group; 50 in placebo group) Age: 0.9 to 10 years Inclusion criteria: children with serologically confirmed dengue shock syndrome Exclusions: not specified |
|
Interventions | 1. Hydrocortisone hemisuccinate: 50 mg/kg, single intravenous dose in
addition to fluid replacement 2. Placebo: sodium chloride 0.9% with same colour and turbidity |
|
Outcomes | 1. Death 2. Duration of shock 3. Requirement of fluid replacement (mL) |
|
Notes | Location: Dr Cipto Mangunkusumo Hospital, Jakarta, Indonesia Transmission: not specified Funding: WHO Project ICPRPD 001 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "divided group using a simple random assignment method", no more detail about the method of sequence generation |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double blind" and "Placebo packaged in indistinguishable coded vials" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up were reported |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Low risk | No other bias identified |