Ruth 1991.
Methods | Single‐center randomized controlled trial in Finland | |
Participants | Included 38 term infants with evidence of perinatal asphyxia (5‐minute Apgar score ≤ 3 or need for mechanical ventilation > 30 minutes after birth) | |
Interventions | Phenobarbital group (n = 21) received conventional therapy plus a phenobarbital loading dose (30 mg/kg IV) prior to 4 hours of age, followed by a second dose of phenobarbital (15 mg/kg) 4 hours after the initial dose. These infants then received 5 mg/kg/day for 5 days Control group (n = 17) received conventional therapy |
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Outcomes | Death before neurodevelopmental assessment Severe neurodevelopmental disability (stated as cerebral palsy) 6‐year neurodevelopmental outcome (assessed using WISC‐r expressed as IQ; neuropsychological tests (VMI, NEPSY) and quality of life scale) |
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Notes | Co‐intervention: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomization was not specified |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not specified |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding of the treatment team and assessors was not specified |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 6‐year follow‐up: unclear how many infants were included, means presented for "testable infants" |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |