Methods |
Randomised double‐blind placebo‐controlled trial |
Participants |
34 infants of gestation > 23 weeks and < 29 weeks, and birth weight > 500 grams and < 1000 grams enrolled by 2 hours of age
Exclusions: major malformations, chromosomal abnormalities, congenital heart disease |
Interventions |
Hydrocortisone intravenously at dose of 1 mg/kg every 12 hours for 2 days, followed by 0.3 mg/kg every 12 hours for 3 days
Control infants received an equivalent volume of normal saline as placebo |
Outcomes |
Blood pressure, urine output, hyperglycaemia, mortality, durations of mechanical ventilation and hospital stay, BPD (oxygen at 36 weeks), infection, NEC, intestinal perforation, PDA, IVH, PVL, cortisol levels |
Notes |
— |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random allocation via sequentially numbered, preassigned treatment designations in sealed, opaque envelopes |
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 |