Summary of findings 4. Summary of findings table ‐ Phenobarbital versus phenytoin as first‐line ASM for clinically diagnosed neonatal seizures.
| Phenobarbital versus phenytoin as first‐line ASM for clinically diagnosed neonatal seizures | ||||||
| Patient or population: neonates with clinically diagnosed seizures Setting: Neonatal intensive care unit Intervention: phenobarbital as first‐line ASM Comparison: phenytoin as first‐line ASM | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with phenytoin as first‐line ASM | Risk with phenobarbital as first‐line ASM | |||||
| Proportion of infants who achieve seizure control after first loading dose of ASM | 356 per 1000 | 683 per 1000 (498 to 939) | RR 1.92 (1.40 to 2.64) | 179 (2 RCTs) | ⊕⊕⊝⊝ Lowa,b | |
| Proportion of infants who achieve seizure control after maximal loading dose ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | Neither of the two included trials reported this outcome. |
| Mortality or neurodevelopmental disability at 18 to 24 months' corrected age ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | Neither of the two included trials reported this outcome. |
| Mortality before hospital discharge | 211 per 1000 | 281 per 1000 (167 to 477) | RR 1.33 (0.79 to 2.26) | 179 (2 RCTs) | ⊕⊝⊝⊝ Very lowc,d,e | |
| Requirement of mechanical ventilation | 0 per 1000 | 0 per 1000 (0 to 0) | RR 7.13 (0.38 to 134.78) | 109 (1 RCT) | ⊕⊝⊝⊝ Very lowd,f | |
| Proportion of infants who develop sedation or drowsiness | 0 per 1000 | 0 per 1000 (0 to 0) | RR 23.00 (1.41 to 375.77) | 70 (1 RCT) | ⊕⊝⊝⊝ Very lowd,f,g | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
| See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_438949398863786458. | ||||||
a Downgraded by one level for serious risk of bias as the trial contributing > 50% weighting to the estimate has a high risk of overall bias b Downgraded by one level for serious inconsistency as there was considerable heterogeneity (I2 = 96%) c Downgraded by one level for serious inconsistency as there was substantial heterogeneity (I2=82%) d Downgraded by one level for serious indirectness of the intervention as the study population included neonates who required second‐ and third‐line ASMs as well e Downgraded by one level for serious imprecision for sample size and event rate not meeting the 'Optimal Information Size' criteria f Downgraded by two levels for very serious imprecision due to very low sample size and event rate not meeting the 'Optimal Information Size' criteria g Downgraded by two levels for very serious risk of bias due to high risk of bias in the only included trial