| Methods |
Randomised controlled trial conducted in India between February 2008 and January 2009 |
| Participants |
80 neonates with mean gestational age of about 37 weeks. Neonates with major congenital malformations and those who had received antibiotics for 24 hours were excluded from the study |
| Interventions |
Dexamethasone was administered at a dose of 0.15 mg/kg per dose at 6‐hourly intervals. Duration of administration of antibiotics was 48 hours. Control group received placebo (saline). Both groups received antibiotics ‐ mainly ceftriaxone and Amikacin ‐ although severely ill participants were treated with meropenem |
| Outcomes |
Mortality, progression of systemic inflammatory response syndrome up to 48 hours, brain stem auditory evoked response after 4 to 6 weeks and again 4 weeks later for participants with initial abnormalities and CSF cytokine levels (TNFalpha and IL‐1beta after 24 ± 6 hours) |
| Notes |
This study provided a power calculation. Study authors aimed to recruit enough participants to give the study 80% power to detect differences in effect between arms if they existed; they set the threshold at a reduction in mortality from 35% to 10% |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random sequence |
| Allocation concealment (selection bias) |
Low risk |
Investigators reported using sealed opaque envelopes to conceal allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
This was an unblinded trial |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Some outcome assessors were blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All participants were included in the analysis and were accounted for |
| Selective reporting (reporting bias) |
Low risk |
We have no reason to think that selective outcome reporting occurred |
| Other bias |
Unclear risk |
Researchers do not report the funding source, although they state that funders played no role in analysis and reporting of the study |
