| Methods |
Multi‐centre randomised placebo‐controlled trial |
| Participants |
Infants at 23 to 26 completed weeks' gestation with study‐defined low blood pressure |
| Interventions |
Hydrocortisone 1 mg/kg loading, then 0.5 mg/kg at 12‐hourly intervals for 6 doses |
| Outcomes |
Short‐term outcomes during primary hospitalisation of death, BPD (not defined), IVH grade III or IV, PVL, and NEC requiring surgery |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Enrolled infants were randomised from a prespecified sequence, allocated by centre, and received treatment from an investigational pharmacist. |
| 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) |
Unclear risk |
Primary outcome of the study was to determine the feasibility of a randomised trial of blood pressure management, rather than effects on bronchopulmonary dysplasia. |
