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. 2016 May 5;2016(5):CD001240. doi: 10.1002/14651858.CD001240.pub3

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)
Outcomes Primary outcome: seizures
Secondary outcomes: adverse effects of medication administration (i.e. drowsiness, bradycardia)
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