| Methods |
Multi‐centre double‐blind randomised controlled trial |
| Participants |
287 preterm infants from 3 weeks of age with oxygen dependency, with or without mechanical ventilation, whose condition was static or deteriorating over the preceding week
Exclusion: major malformations |
| Interventions |
Dexamethasone 0.6 mg/kg/d for 1 week intravenously or orally, with an option to give a second tapering 9‐day course (0.6, 0.4, and 0.2 mg/kg/d for 3 days each) if, after initial improvement, relapse occurred. Matching saline placebo was given intravenously (or orally if no intravenous line) for 1 week. |
| Outcomes |
Durations of mechanical ventilation, death, sepsis, NEC, pneumothorax, blood pressure, plasma glucose, GI bleeding, O2, hospital stay
Cerebral palsy and blindness in survivors as assessed by questionnaires from general practitioners, healthcare visitors, and parents |
| Notes |
Babies could be enrolled if breathing spontaneously. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random allocation via unmarked vials and telephone randomisation. Stratification by clinical centre and by whether or not babies were ventilator‐dependent |
| Allocation concealment (selection bias) |
Low risk |
Random allocation via unmarked vials and telephone randomisation. Stratification by clinical centre and by whether or not babies were ventilator‐dependent
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 measurement: yes |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Survivors at 3 years were followed up. 14 infants died after discharge, and follow‐up information was available for 209 of the 212 infants (99% follow‐up). |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported |
