Comparison · NCT04320940-deaths
Phenobarbital Sodium Injection 20mg vs Phenobarbital Sodium Injection 40mg: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Phenobarbital Sodium Injection 20mg vs Phenobarbital Sodium Injection 40mg: deaths from any cause. Trial comparisons, record NCT04320940-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04320940-deaths
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk in group 2 | 0 | 0 | 0.793 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.793 | 0.561 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Phenobarbital Sodium Injection 20mg | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required).~Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. | 0 | 3 | EG000 |
| Group 2 | Phenobarbital Sodium Injection 40mg | Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required).~Phenobarbital Sodium Injection: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose. | 0 | 1 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
All-Cause Mortality and Serious Adverse Events were assessed up to 30 days following the first treatment, on average 45 days. Other (Not Including Serious) Adverse Events were assessed for up to 24 hours following the first treatment and up to 4 days.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
- NCT number
- NCT04320940
- Phases
- PHASE3
- Conditions
- Epilepsy, Benign Neonatal
- Interventions
- Phenobarbital Sodium Injection
- Lead sponsor
- NEMA Research, Inc.
- Results first posted
- 2023-10-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04320940?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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