Methods |
Three‐armed randomised controlled trial: (1) nebulised pentoxifylline, (2) intravenous dexamethasone, (3) nebulised water placebo |
Participants |
150 infants < 1500 grams birth weight who needed oxygen on fourth day of life, regardless of the need for assisted ventilation. Major malformations and grade 3 or 4 IVH led to exclusions. |
Interventions |
Dexamethasone 0.25 mg/kg/dose every 12 hours for 3 days |
Outcomes |
Primary endpoint BPD (oxygen dependency at 36 weeks). Secondary endpoints included PDA, IVH and PVL, |
Notes |
All prespecified outcomes reported |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation table |
Allocation concealment (selection bias) |
Unclear risk |
Not clearly stated |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Unable to blind treatment groups for comparison of dexamethasone vs nebulised water placebo |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Unable to blind treatment groups for comparison of dexamethasone vs nebulised water placebo |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Short‐term outcomes reported for all participants |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported |