Trial · NCT04320940
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
NCT04320940, Phase 3, Terminated, NEMA Research, Inc.; results first posted 2023-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures. Trials, record NCT04320940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04320940
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
- NCT number
- NCT04320940
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- NEMA Research, Inc.
- Conditions
- Epilepsy, Benign Neonatal
- Interventions
- Phenobarbital Sodium Injection
- First posted
- 2020-03-25
- Last updated
- 2023-10-26
- Results first posted
- 2023-10-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | 24 hours | Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment. |
| Secondary | Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | 2 hours | Percent of neonates who do not require additional seizure treatment after 2 hours of the first dose of phenobarbital. |
| Secondary | Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital. | 24 hours | Percent of neonates who do not require additional seizure treatment after the second dose of phenobarbital within the first 24 hours of treatment. |
| Secondary | Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection. | 48 hours | Number of subject required monitoring of seizure burden over 48 hours following initial administration of the phenobarbital injection. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | 24 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | 2 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital. | 24 hours | Three subjects (two in the low-dose and one in the high-dose groups) received a first dose and no subsequent doses of the medication. One subject in the low-dose group received an initial dose (20 mg/kg) at 14:10 on July 15 and a second dose (20 mg/kg) at 17:25 on the same day. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection. | 48 hours | One subject in the low-dose group received an initial dose (20 mg/kg) at 14:10 on July 15 and a second dose (20 mg/kg) at 17:25 on the same day. Maintenance doses of 5 mg/kg were administered to this subject once daily on July 16, 17, and 18. Only this subject required monitoring of seizure burden over 48 hours following initial administration of the phenobarbital injection | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | Phenobarbital Sodium Injection 20mg | 2 | Participants | ||
| Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | Phenobarbital Sodium Injection 40mg | 1 | Participants | ||
| Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | Phenobarbital Sodium Injection 20mg | 2 | Participants | ||
| Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital. | Phenobarbital Sodium Injection 40mg | 1 | Participants | ||
| Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital. | Phenobarbital Sodium Injection 20mg | 1 | Participants | ||
| Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital. | Phenobarbital Sodium Injection 40mg | 0 | Participants | ||
| Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection. | Phenobarbital Sodium Injection 20mg | 1 | Participants | ||
| Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection. | Phenobarbital Sodium Injection 40mg | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phenobarbital Sodium Injection 20mg | 3 | |
| Overall Study | STARTED | Phenobarbital Sodium Injection 40mg | 1 | |
| Overall Study | COMPLETED | Phenobarbital Sodium Injection 20mg | 3 | |
| Overall Study | COMPLETED | Phenobarbital Sodium Injection 40mg | 1 | |
| Overall Study | NOT COMPLETED | Phenobarbital Sodium Injection 20mg | 0 | |
| Overall Study | NOT COMPLETED | Phenobarbital Sodium Injection 40mg | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Phenobarbital Sodium Injection 20mg | 1 | 3 | 1 |
| serious | pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Phenobarbital Sodium Injection 40mg | 0 | 1 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenobarbital Sodium Injection 20mg | 0 | 3 |
| Total, all-cause mortality | Phenobarbital Sodium Injection 40mg | 0 | 1 |
| Total, other adverse events | Phenobarbital Sodium Injection 20mg | 0 | 3 |
| Total, other adverse events | Phenobarbital Sodium Injection 40mg | 0 | 1 |
| Total, serious adverse events | Phenobarbital Sodium Injection 20mg | 1 | 3 |
| Total, serious adverse events | Phenobarbital Sodium Injection 40mg | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phenobarbital Sodium Injection 20mg vs Phenobarbital Sodium Injection 40mg: Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection. | Trial comparisons |
| 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 |
| 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 |
| Phenobarbital Sodium Injection 20mg vs Phenobarbital Sodium Injection 40mg: deaths from any cause | Trial comparisons |
| Phenobarbital Sodium Injection 20mg vs Phenobarbital Sodium Injection 40mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04320940
GET https://conductscience.org/api/trials/v1/NCT04320940/registered