Methods |
Double‐blind randomised controlled trial |
Participants |
23 preterm infants, 3 to 4 weeks old, who weighed < 1501 grams at birth, with radiological findings of BPD and needing mechanical ventilation in > 34% oxygen; failure of medical treatment
Exclusions: PDA, pneumonia, sepsis, hypertension |
Interventions |
Dexamethasone 0.5 mg/kg/d for 3 days, 0.4 mg/kg/d for 2 days, 0.25 mg/kg/d for 2 days, given by nasogastric tube as a single daily dose, then hydrocortisone every 6 hours for 10 days
Infants in the control group received equal volumes of saline. |
Outcomes |
Inspired oxygen concentration, ventilator settings, extubation < 9 days, hyperglycaemia, sepsis, hypertension, ROP; durations of oxygen, mechanical ventilation, and hospital stay |
Notes |
— |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random allocation achieved by drawing a card prepared from random number tables in the pharmacy; stratification for birth weight (< 1000 grams, 1000 grams to 1250 grams, and 1251 grams to 1500 grams) |
Allocation concealment (selection bias) |
Low risk |
Allocation concealment: 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 |
Low risk |
Complete follow‐up: yes |
Selective reporting (reporting bias) |
Unclear risk |
All prespecified outcomes reported |