| Methods |
An open controlled trial using alternate allocation to phenobarbital or no injection
Blinding of randomisation: no
Blinding of intervention: no
Complete follow‐up: yes
Blinding of main outcome measurement: yes |
| Participants |
Infants with birthweights below 1250 g and infants with birthweights 1250‐1500 g who required mechanical ventilation in the first 24 h. An ultrasound scan showing absence of IVH was also a requirement. N = 60. No information on infants excluded or lost after enrolment |
| Interventions |
A loading dose of 20 mg/kg phenobarbital intramuscularly at a median time of 2 h after birth (range 1‐22 h) |
| Outcomes |
Papile grade of IVH on ultrasound, death, pneumothorax, hypercapnia (pCO2 > 8 kPa), acidosis (pH < 7.15). The age limit for death is not specified but "one cot death" occurred at home at 4 months |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Alternate allocation (quasi‐random) |
| Allocation concealment (selection bias) |
High risk |
Next allocation always known as alternate allocation |
| 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 |
Low risk |
An experienced observer unaware of treatment allocation assessed outcome |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All subjects are followed up, but no information provided on postmortem diagnoses in infants that died |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a judgement as we have no access to a trial protocol |
