Study characteristics |
Methods |
Multi‐centre double‐blind randomised controlled trial |
Participants |
Inclusion: 248 preterm infants with birth weight 500 grams to 2000 grams, 1 to 3 days old, requiring mechanical ventilation with > 40% oxygen
Exclusions: active bleeding, hypertension, hyperglycaemia, active infection, lethal congenital anomaly |
Interventions |
Intravenous dexamethasone 0.25 mg/kg every 12 hours 6 times
Controls given saline placebo |
Outcomes |
|
Notes |
— |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random allocation, stratified by centre and birth weight, from random numbers list in the pharmacy |
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 for short‐term; 84% for long‐term |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported |
Other bias |
Low risk |
None |