Methods |
Placebo‐controlled randomised trial |
Participants |
248 infants, birth weight ≤ 1500 grams, gestation < 34 weeks, with evidence of "birth asphyxia" (1‐minute Apgar score < 5, prolonged resuscitation, and metabolic acidosis (HCO3 < 15 mmol/L within 1 hour of birth)) |
Interventions |
7‐Day course of dexamethasone 1 mg/kg 12‐hourly beginning on first day of life |
Outcomes |
Neonatal mortality, mortality to discharge, NEC, PDA, sepsis, severe IVH |
Notes |
Possible exclusion of 5 deaths after randomisation, but not clear which group they came from |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random allocation via list of random numbers |
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 measurement: yes |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up: yes |
Selective reporting (reporting bias) |
Low risk |
Primary prespecified outcome of NEC was reported, as were a large number of other outcomes. |