Hall 1998.
| Methods | Single‐center randomized controlled trial in the US | |
| Participants | Included 40 term or post‐term infants with severe perinatal asphyxia (initial arterial pH ≤ 7 with base deficit ≥ 15 mEq/L; 5‐minute Apgar ≤ 3; or failure to initiate spontaneous respirations at 10 minutes of life) without congenital abnormality | |
| Interventions | Phenobarbital treatment group (n = 20) received a phenobarbital loading dose (40 mg/kg IV over 60 minutes) immediately following trial entry plus conventional therapy Control group (n = 20) received conventional therapy Conventional therapy included phenobarbital administration for the treatment of clinical seizures |
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| Outcomes | Primary outcome: incidence of clinical seizures Secondary outcomes: total LDH, CK and the presence or absence of CK‐BB isoenzymes in CSF (obtained on day 1 and day 2), death before neurodevelopmental assessment, and neurodevelopmental outcome at 3 years of age (Gessell, Bayley, or Stanford‐Binet) Neurodevelopmental assessments were completed at 6, 12, 24, and 36 months of age Adverse effects of phenobarbital administration were also evaluated |
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| Notes | Co‐intervention: control group received mean of 27 mg/kg of phenobarbital in first 24 hours, compared to a mean of 39 mg/kg in the experimental group All infants were outborn and transferred to the neonatal intensive care unit within the first day of life. Absence of seizure activity prior to transfer is inferred but not specifically stated Results were only reported for the 31 infants (15 in the phenobarbital treatment group and 16 in the control group) that completed the study |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Low risk | Allocation concealment was by sealed envelope |
| Blinding (performance bias and detection bias) All outcomes | High risk | There was no blinding of the treatment team or the assessors and no placebo used |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Postrandomization: 5/20 (25%) infants lost from intervention group (2 unable to obtain LP, 1 protocol violation, 2 lost to follow‐up), 4/20 (20%) of infants lost from the control group (1 unable to obtain LP, 3 lost to follow‐up) |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |