Comparison · NCT04320940-a229fcf8
Phenobarbital Sodium Injection 20mg vs Phenobarbital Sodium Injection 40mg: Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
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: Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. Trial comparisons, record NCT04320940-a229fcf8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04320940-a229fcf8
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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 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.333 | -0.792 | 0.505 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.3 | 1.48 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Phenobarbital Sodium Injection 20mg than on Phenobarbital Sodium Injection 40mg | 3 | from the risk difference interval | the interval includes no difference |
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. | 2 | 3 | OG000 |
| 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. | 1 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
- Description
- Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment.
- Time frame
- 24 hours
- Population
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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