Study characteristics |
Methods |
Multi‐centre randomised double‐blind trial |
Participants |
384 infants at < 30 weeks' gestation with RDS by clinical and radiographic signs, needing IPPV at 12 to 18 hours of age; had received at least 1 dose of surfactant |
Interventions |
Dexamethasone 0.5 mg/kg at 12 to 18 hours of age, second dose 12 hours later
Control group given an equal volume of placebo |
Outcomes |
Primary outcomes
-
Survival
Length of time in oxygen, on ventilation, to regain birth weight, and in hospital
Hyperglycaemia
Hypertension
IVH
PDA
Sepsis
NEC
Isolated GI perforation
ROP
Air leak
Discharged home on oxygen
|
Notes |
— |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Random allocation in the pharmacy via labelled syringes. Stratification by centre. Exact method of randomisation not stated |
Allocation concealment (selection bias) |
Low risk |
Allocation concealment: yes |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Blinding of intervention: yes |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Blinding of outcome measurement: yes |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up: yes |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported |
Other bias |
Low risk |
None |