Vela 1987.
Methods | Single‐center double‐blind randomized controlled trial in Spain | |
Participants | Included 17 term infants with perinatal asphyxia (defined as 3 of the following criteria: multiple late fetal heart rate decelerations, fetal bradycardia for > 20 minutes, meconium‐stained amniotic fluid, Apgar score at 5 minutes of ≤ 7, requiring mechanical ventilation, requiring IV bicarbonate therapy) | |
Interventions | Phenobarbital group (n = 9) received conventional therapy plus phenobarbital (12 mg/kg IM, followed by 6 mg/kg/day for 7 days) Phenytoin group (n = 8) received conventional therapy plus phenytoin (12 mg/kg IM, followed by 6 mg/kg/day for 7 days) |
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Outcomes | Primary outcome: seizures Secondary outcomes: adverse effects of medication administration (i.e. drowsiness, bradycardia) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method for randomization not stated |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not specified |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Referred to as a double‐blind trial, blinding of treatment team or assessors (or both) not clearly stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data was complete to 100% |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |