Study characteristics |
Methods |
Double‐blind placebo‐controlled randomised trial |
Participants |
Inclusion: 44 preterm infants < 24 hours old with respiratory distress confirmed both clinically and radiologically |
Interventions |
Hydrocortisone 25 mg/kg on admission and 12 hours later intravenously
Control group given placebo |
Outcomes |
Mortality
FiO₂
Cortisol levels
Blood gases
|
Notes |
The oldest study, carried out in 1972. Used hydrocortisone in a very short course of treatment |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random allocation via random numbers and sealed envelopes |
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 measurements: 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 |