Summary of findings 5. Summary of findings table ‐ Phenobarbital versus Lorazepam as first‐line ASM for clinically diagnosed neonatal seizures.
| Phenobarbital versus Lorazepam 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: Lorazepam 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 Lorazepam as first‐line ASM | Risk with Phenobarbital as first‐line ASM | |||||
| Proportion of infants who achieve seizure control after the first loading dose of ASM | 889 per 1000 | 631 per 1000 (471 to 836) | RR 0.71 (0.53 to 0.94) | 71 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | |
| Proportion of infants who achieve seizure control after the maximal loading dose of ASM ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | The included trial did not report this outcome |
| Mortality or neurodevelopmental disability at 18 to 24 months' corrected age ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | The included trial did not report this outcome. |
| Mortality before hospital discharge | 194 per 1000 | 342 per 1000 (154 to 768) | RR 1.76 (0.79 to 3.95) | 71 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c,d | |
| Proportion of infants who develop sedation or drowsiness | 56 per 1000 | 314 per 1000 (75 to 1000) | RR 5.66 (1.35 to 23.71) | 71 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c,d | |
| *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_438956545731624502. | ||||||
a Downgraded by two levels for very serious risk of bias due to high risk of bias in the only included trial b Downgraded by one level for serious imprecision for sample size and event rate not meeting the 'Optimal Information Size' criteria c 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 d Downgraded by two levels for very serious imprecision due to very low sample size and event rate not meeting the 'Optimal Information Size' criteria