Stark 2001.

Study characteristics
Methods	Multi‐centre randomised double‐blind trial
Participants	220 infants with birth weight 501 grams to 1000 grams, mechanically ventilated < 12 hours. Infants > 750 grams also needed to receive surfactant and to have FiO₂ > 0.29
Interventions	Dexamethasone 0.15 mg/kg/d for 3 days, then tapered over 7 days Saline placebo
Outcomes	Mortality or BPD Oxygen at 28 days PIE Late corticosteroid treatment Hypertension Hyperglycaemia GI perforation
Notes	Factorial design; infants also randomised to routine ventilator management or a strategy of minimal ventilator support to reduce mechanical lung injury. After 220 infants were enrolled (sample size estimate was 1200), the trial was halted owing to unanticipated adverse events
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random allocation via numbers generated by a random, permuted block algorithm, stratified by birth weight
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	Unclear risk	Early stopping of trial may or may not introduce bias