| Methods |
Double‐blind randomised controlled trial |
| Participants |
78 infants < 1501 grams who were ventilator‐dependent at 7 days
Exclusions: complex congenital anomalies, pulmonary hypoplasia, haemodynamic instability |
| Interventions |
Dexamethasone 0.25 mg/kg/d 12‐hourly for 2 days, repeated every 10 days until 36 weeks' PMA or until ventilator support or supplemental oxygen no longer needed. An occasional dose of study drug was administered as an intramuscular injection when intravenous access was not possible.
Control infants were given an equivalent volume of saline intravenously twice daily for 3 days. |
| Outcomes |
Inspired oxygen concentration, duration of supplemental oxygen, survival without oxygen at 30 days and 34 weeks, CLD, GI bleeding, IVH, death, NEC, ROP (> stage II), hyperglycaemia, pulmonary air leak, sepsis, worsening IVH (grade > II) |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random allocation via sealed envelopes kept in the pharmacy. Stratification by sex and birth weight (< 1000 grams vs ≥ 1000 grams) |
| Allocation concealment (selection bias) |
Low risk |
Random allocation via sealed envelopes kept in the pharmacy. Stratification by sex and birth weight (< 1000 grams vs ≥ 1000 grams)
Blinding of randomisation: yes |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Blinding of intervention: 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: yes |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Complete follow‐up: no; results given for 78 out of 88 enrolled infants |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported |
