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. 2014 Jul 30;2014(7):CD003488. doi: 10.1002/14651858.CD003488.pub3
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