| Study characteristics |
| Methods |
Multi‐centre double‐blind placebo‐controlled randomised trial |
| Participants |
Inclusion: 109 infants with birth weight 500 grams to 999 grams, gestation < 32 weeks, need for mechanical ventilation and supplemental oxygen by 4 hours of age. Stratified by weight (500 grams to 749 grams vs 750 grams to 999 grams)
Exclusions: life‐threatening congenital anomalies or known chromosomal anomaly |
| Interventions |
4 doses of dexamethasone 0.25 mg/kg each at 12‐hourly intervals or normal saline as placebo. First dose was given before 6 hours. Open‐label dexamethasone was allowed when deemed necessary by attending physician, but its use was discouraged |
| Outcomes |
Survival to 36 weeks without IVH (grade III to IV) PVL (echodensities after first week or periventricular cysts on ultrasound) BPD (oxygen at 36 weeks) Growth Duration of assisted ventilation and oxygen Late corticosteroid treatment Infection Hyperglycaemia Hypertension, ROP PDA GI bleeding and perforation NEC |
| Notes |
This paper also reported a meta‐analysis of early short vs early prolonged dexamethasone treatment |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random allocation by coded vials prepared in the pharmacy at each centre |
| 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 primary and secondary outcomes reported |
| Other bias |
Low risk |
None |
