| Methods |
Open randomised controlled trial. The method of randomisation was not described
Blinding of randomisation: cannot determine
Blinding of intervention: no
Complete follow‐up: yes
Blinding of main outcome measurement |
| Participants |
Newborn infants with birthweight < 1500 g with a normal cerebral ultrasound scan before 6 h of birth and receiving respiratory support. n = 19. No information on infants excluded after enrolment |
| Interventions |
A loading dose of phenobarbital 30 mg/kg intravenously within 6 h of birth, followed by a maintenance dose of 5 mg/kg per day for 72 h |
| Outcomes |
Cerebral ultrasound scans were carried out daily by sonographers who were blind to the initial treatment allocation. IVH was graded according to the Papile scale, mechanical ventilation, pneumothorax, hypercapnia (> 60 mm Hg), acidosis (pH < 7.15), death |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The method of randomisation is not described |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information provided |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Treatment allocation was most likely not blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Cerebral ultrasound scans were carried out daily by sonographers who were blind to the initial treatment allocation |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a judgement as we have no access to a trial protocol |
