| Methods |
Randomised trial. |
| Participants |
39 women at risk of imminent risk of preterm birth before 32 weeks' gestation. Excluded: congenital abnormalities, maternal allergy to phenobarb, maternal liver, kidney or renal disease, neonatal birthweight < 500 g. |
| Interventions |
Phenobarbital IV 2 doses of 350 mg 10 minutes apart, each given over 10 minutes; if not born in 24 hours 250 mg/day in 2 doses (n = 21). Control group received no treatment (n = 18). |
| Outcomes |
PVH, mortality, other neonatal morbidity. |
| Notes |
Requires author clarification re exclusions, antenatal corticosteroid usage. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
High risk |
Randomised using a card deck. |
| Allocation concealment? |
Unclear risk |
Not reported. |
| Blinding?
All outcomes |
High risk |
No placebo was used however the primary outcome of PVH was blinded. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
No information on exclusions. |
| Free of selective reporting? |
Low risk |
No indication of selective reporting. |
| Free of other bias? |
High risk |
The treatment group included 15 male infants whereas the control group only had 5 males. |