Methods |
Randomised controlled trial |
Participants |
Infants with birthweights < 1500 g and under 32 weeks' gestation |
Interventions |
5 mg/kg/day dose of phenobarbital intravenously for the first 5 days |
Outcomes |
Cerebral ultrasound scans were carried out on days 1, 3, 5 and 10; IVH was graded according to the Papile scale; neonatal death; pulmonary haemorrhage; oxygen requirement; respiratory rate; patent ductus arterious up to 10 days of age |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
The method of randomisation was not described |
Allocation concealment (selection bias) |
Unclear risk |
Insufficient information provided |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No information provided, but participants and personnel were most likely not blinded |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No information provided on blinding of outcome assessment |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No information on infants excluded or lost after enrolment |
Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a judgement as we have no access to a trial protocol |