| Methods |
Randomised controlled trial. |
| Participants |
151 women < 31 weeks' gestation in preterm labour or with preterm prelabour rupture of the membranes, or maternal or fetal complication requiring delivery.
Excluded if on barbiturates or cardio‐respiratory disease, or porphyria. |
| Interventions |
10 mg/kg phenobarbital intravenously (minimum 500 mg maximum 700 mg) over 30 minutes (n = 60).
Placebo involved 0.9% saline in equal volume over 30 minutes (n = 50). |
| Outcomes |
Primary outcome: IVH.
Other: neonatal mortality, respiratory distress syndrome, Apgar scores. |
| Notes |
Postnatal phenobarbital given if ventilated (91% phenobarbital group, 75% placebo group). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Randomly assigned to either the treatment or control group by use of a computer‐generated random number list. |
| Allocation concealment? |
Unclear risk |
Unclear if number list was concealed. |
| Blinding?
All outcomes |
Low risk |
A placebo was used. The patient, obstetric, neonatal, nursing and radiology staff were unaware of the treatment allocation. The assessment of the primary outcome was blinded. |
| Incomplete outcome data addressed?
All outcomes |
High risk |
37% (32/86) of infants randomised to the phenobarbital group were lost to follow up, whereas only 20% (17/84) of those randomised to the placebo group were lost to follow up. Reasons for exclusion included incomplete infusion, delivery after 31 weeks' gestation and neonatal death prior within 24 hours of birth. |
| Free of selective reporting? |
Low risk |
No indication of selective reporting. |
| Free of other bias? |
Low risk |
|
