| Methods |
Multi‐centre randomised double‐blind trial |
| Participants |
542 infants weighing 501 grams to 1000 grams who required assisted ventilation < 12 hours, had received surfactant by 12 hours, were physiologically stable, and had no life‐threatening congenital anomalies |
| Interventions |
Dexamethasone 0.5 mg/kg/d for 3 days, 0.25 mg/kg/d for 3 days, 0.10 mg/kg/d for 3 days, and 0.05 mg/kg/d for 3 days. Control infants received a similar volume of normal saline.
Infants in either group could receive late postnatal corticosteroids beginning on day 14 if they were on assisted ventilation with supplemental oxygen > 30%. |
| Outcomes |
Primary outcome was BPD or death at 36 weeks' adjusted age.
Secondary outcome measures included clinical status at 14 days and 28 days, duration of assisted ventilation, supplemental oxygen and hospital stay, treatment with late postnatal corticosteroids, proven sepsis, hypertension and hyperglycaemia requiring therapy, weight at 36 weeks, usual complications of prematurity |
| Notes |
Published as an extended abstract and presented at a clinical meeting |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random allocation in hospital pharmacies by opening opaque, sealed envelopes. Precise 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 |
