Summary of findings 7. Summary of findings table ‐ Phenobarbital + bumetanide versus phenobarbital alone for EEG‐confirmed neonatal seizures.
| Phenobarbital + bumetanide versus phenobarbital alone for EEG‐confirmed neonatal seizures | ||||||
| Patient or population: neonates with EEG‐confirmed seizures Setting: Neonatal intensive care unit Intervention: phenobarbital + bumetanide Comparison: phenobarbital alone | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with phenobarbital alone | Risk with phenobarbital + bumetanide | |||||
| Proportion of infants who achieve seizure control after the first loading dose of ASM | 313 per 1000 | 297 per 1000 (116 to 750) | RR 0.95 (0.37 to 2.40) | 43 (1 RCT) | ⊕⊕⊝⊝ Lowa | |
| Proportion of infants who achieve seizure control after the maximal loading dose of the 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 | 188 per 1000 | 38 per 1000 (4 to 326) | RR 0.20 (0.02 to 1.74) | 43 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | |
| Cognitive impairment at 18‐24 months | 300 per 1000 | 159 per 1000 (39 to 645) | RR 0.53 (0.13 to 2.15) | 29 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | |
| Requirement of mechanical ventilation | Not pooled | Not pooled | Not pooled | (1 RCT) | ‐ | |
| Proportion of infants who develop epilepsy post‐discharge | 308 per 1000 | 348 per 1000 (132 to 914) | RR 1.13 (0.43 to 2.97) | 39 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | |
| *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_438957230819281917. | ||||||
a Downgraded by two levels for very serious imprecision due to very low sample size and event rate not meeting the 'Optimal Information Size' criteria b 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