| Methods |
Randomised controlled trial. |
| Participants |
126 women prior to anticipated preterm delivery 26‐34 weeks' gestation.
Excluded if on anticonvulsants, or if drug abusers, or major congenital abnormality of fetus. |
| Interventions |
Phenobarbital (n = 31) or placebo (n = 33) 30 mg 3 times a day or 90 mg once daily at least 24 hours before birth.
All infants given a 6‐day maintenance therapy of phenobarbital. Those in the placebo group were given a loading dose of 20 mg/kg. |
| Outcomes |
Primary outcome: IVH. |
| Notes |
Reasons for exclusions postrandomisation: gestational age > 34 weeks, delivered < 24 hours from entry, stopped medication, withdrew. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Randomly selected and assigned. |
| Allocation concealment? |
Unclear risk |
Not reported. |
| Blinding?
All outcomes |
Unclear risk |
Placebo used. Unknown if primary outcome was blinded although unblinding likely in view of differential treatment of neonates. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
49% (62/126) excluded postrandomisation. |
| Free of selective reporting? |
Low risk |
No indication of selective reporting. |
| Free of other bias? |
Unclear risk |
Numbers of participants do not match between abstract and main published paper. |
