| Methods |
Open randomised controlled trial. Randomisation was described as by lottery but there is no description of how allocation concealment was achieved
Blinding of intervention: no
Complete follow‐up: yes
Blinding of main outcome measurement: yes |
| Participants |
Infants with birthweights < 1500 g, admitted to the NICU within 6 h, without congenital malformations and where the mother had not received barbiturates during pregnancy. n = 60. No information on infants excluded or lost after enrolment |
| Interventions |
2 loading doses of 10 mg/kg phenobarbital each administered intravenously 12 h apart. Maintenance dose of 2.5 mg/h every 12 h was begun 12 h after. Doses were adjusted to maintain serum concentrations in the 20‐30 μg/mL range for 7 days |
| Outcomes |
Papile grade of IVH on ultrasound, ventriculomegaly, mechanical ventilation, pneumothorax requiring drainage, hypercapnia (pCO2 > 60 mm Hg), hypotension (systolic blood pressure 10 mm Hg below expected value or impaired perfusion), bicarbonate therapy, death |
| 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) |
Low risk |
Randomisation is described as by lottery |
| Allocation concealment (selection bias) |
Low risk |
No information provided, but it is likely the next allocation was not known in advance as a lottery system was used |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Most likely there was no blinding of intervention |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome assessment was done by ultrasonographers and neuroradiologists unaware of treatment allocation |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All infants were followed‐up. The infants that died had a postmortem examination to ensure complete diagnosis of IVH |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a judgement as we have no access to a trial protocol |
