| Methods |
Open controlled trial. The method of randomisation and means of allocation concealment were not described
Blinding of intervention: no
Complete follow‐up: yes
Blinding of outcome measurement: cannot determine |
| Participants |
Newborn infants with gestational ages 27‐34 weeks and who were ventilator dependent. n = 60. No information on infants excluded or lost after enrolment |
| Interventions |
Phenobarbital 20 mg/kg intravenously as a loading dose within 12 h of birth followed by phenobarbital 2.5 mg/kg every 12 h for the next 5 days |
| Outcomes |
Cerebral ultrasound every 48 h for 14 days, IVH graded as I/II or III/IV on the Papile scale, death. It is not clear whether the ultrasonographers were blind to treatment allocation |
| Notes |
Cerebral ultrasound was not carried out prior to trial entry so it was not possible to exclude babies who already had IVH before the first dose of phenobarbital |
| 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 |
No information provided |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Participants and personnel were most likely not blinded for intervention |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
It is not clear whether the ultrasonographers were blind to treatment allocation |
| 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 |
