| Methods |
Double‐blind randomised controlled trial |
| Participants |
118 preterm infants, < 1501 grams, age 15 to 25 days, ventilator‐dependent over 30% oxygen; no PDA, major malformation, HIV, or hepatitis B virus infection |
| Interventions |
42‐Day tapering course of dexamethasone or equal volume of normal saline. Dexamethasone 0.25 mg/kg 12‐hourly for 3 days, 0.15 mg/kg 12‐hourly for 3 days, then 10% reduction in dose every 3 days until dose of 0.1 mg/kg had been given for 3 days, from which time 0.1 mg/kg every other day until 42 days after entry |
| Outcomes |
Duration of ventilation, oxygen, hospital stay; death, oxygen at 36 weeks' PMA, ROP (stage 3), infection, hypertension, hyperglycaemia
Follow‐up: Bayley MDI and PDI, cerebral palsy, abnormal neurological examination findings |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random allocation within 6 strata according to birth weight (500 grams to 800 grams, 801 grams to 1100 grams, and 1101 grams to 1500 grams) and sex. Method not stated |
| Allocation concealment (selection bias) |
Low risk |
Random allocation within 6 strata according to birth weight (500 grams to 800 grams, 801 grams to 1100 grams, and 1101 grams to 1500 grams) and sex. Method not stated
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: yes |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up: yes for outcomes measured within first year; no for outcomes measured at 5 or more years |
| Selective reporting (reporting bias) |
Unclear risk |
All prespecified outcomes reported |
