Gathwala 2011.
| Methods | Single‐center open label, randomized controlled trial in India | |
| Participants | Included 72 full term neonates (all inborn) with severe perinatal asphyxia (cord blood pH < 7 and Apgar score ≤ 5 at 5 minutes) without obvious congenital malformation | |
| Interventions | Phenobarbital group (n = 36) received a phenobarbital loading dose (40 mg/kg IV infusion over 60 minutes) within the first 2 hours of life, followed by conventional therapy per unit protocol for HIE. Heart rate, oxygen saturation, respiration, and mean arterial pressure were monitored continuously during administration of phenobarbital Control group (n = 36) were managed with conventional therapy per unit protocol for the management of HIE |
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| Outcomes | Primary outcome: CSF levels of lipid peroxides (MDA) and antioxidant enzymes (SOD and GPx) at 12 ± 2 hours of life Secondary outcomes: death, seizure activity, neurologic exam at discharge and neurologic outcome at 1‐month follow‐up (based on neurologic exam, MRI and EEG results) HIE staging for each infant according to the criteria of Sarnat and Sarnat Cranial ultrasounds on day 3 and day 7 of life Adverse effects of phenobarbital administration |
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| Notes | Reported on seizure duration. Incidence data was requested without response from the authors There were no specific data given for the number of infants from each group with neonatal seizures. The authors stated that the incidence of neonatal seizures was comparable in the phenobarbital group and the control group |
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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 | Random number sequences were placed in sealed envelopes and opened following infants resuscitation if selection criteria met |
| Blinding (performance bias and detection bias) All outcomes | High risk | There was no blinding of the treatment team or assessors. No placebo was used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 1‐month follow‐up: 2/32 (6%) living infants missing from the intervention group, 0/30 (0%) living infants missing for the control group |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |