| Methods |
Open randomised controlled trial
Randomisation was by using a deck of cards but it is not clear how blinding to treatment allocation was achieved
Blinding of intervention: no
Blinding of main outcome measurement: yes
Complete follow‐up: yes |
| Participants |
Infants < 24 h old with birthweights < 1500 g or gestation < 33 weeks were all eligible. Infants with gestational ages 33‐36 weeks or birthweight > 1500 g were eligible if they required mechanical ventilation for RDS. Another requirement was a cranial ultrasound scan showing no haemorrhage. n = 42 |
| Interventions |
2 intravenous loading doses of phenobarbital 10 mg/kg 12 h apart, followed by maintenance doses of 2.5 mg/kg intravenously or orally every 12 h for 6 days |
| Outcomes |
Ultrasound diagnosis of grade of IVH as mild (grade I or II on Papile scale) or medium/severe (grade III or IV on Papile scale), death mechanical ventilation, pneumothorax, hypotension (< 2 SD below mean), pH < 7.2, pCO2 > 60 mm Hg, pCO2 < 25 mm Hg, bicarbonate administration (for metabolic acidosis) |
| Notes |
Of 95 potential trial participants, 42 were excluded because of IVH on the initial ultrasound scan. The control group were, on average, 1.1 weeks less mature and 220 g lighter than the phenobarbital group. No infants excluded after enrolment |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was by using a deck of cards |
| Allocation concealment (selection bias) |
Unclear risk |
It is not clear how blinding to treatment allocation was achieved |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Intervention was most likely not blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome assessment was done by a paediatric radiologist unaware of the treatment allocation |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Follow‐up was complete |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a judgement as we have no access to a trial protocol |
