| Methods |
Multi‐centre placebo‐controlled randomised trial |
| Participants |
253 infants < 30 weeks' gestation, within 9 hours of birth at entry; all mechanically ventilated |
| Interventions |
Hydrocortisone 1 mg/kg/d as continuous infusion for 5 days, then 0.5 mg/kg/d for 2 days. Also given tri‐iodothyronine 6 µg/kg/d for 5 days, halving to 3 µg/kg/d for 2 days
Controls given equal volume infusion of 5% dextrose |
| Outcomes |
Primary outcome was death or ventilator dependence at 7 days, or death or oxygen dependence at 14 days.
Secondary outcomes included duration of ventilation, oxygen dependence, and hospitalisation; oxygen dependency at 36 weeks; IVH, PVL, PDA, and NEC |
| Notes |
Hydrocortisone combined with T3 infusion |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation by Oxford Perinatal Trials Unit |
| 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 |
