Back to resultsEfficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Primary Purpose
Epilepsy, Benign Neonatal
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Phenobarbital Sodium Injection
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Benign Neonatal focused on measuring Neonatal Seizures, Phenobarbital, Anticonvulsants
Eligibility Criteria
Inclusion Criteria:
- Male or female neonates with a gestational age of ≥ 34 - ≤44 weeks admitted into the NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral hemorrhage, central nervous system infection)
- Parental informed consent (in-person or remote consent)
- Undergoing continuous video electroencephalogram (cvEEG) monitoring
- Has evidence of electrographic seizure burden of at least 30 seconds/h
Exclusion Criteria:
- Received anticonvulsant treatment, including phenobarbital, prior to randomization (with exception of lorazepam administered for sedation > 24 hours before enrollment)
- Strong suspicion or confirmed diagnosis of brain malformation, inborn error of metabolism genetic syndrome, or major congenial malformation prior to randomization
- Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic disorder
- Death appears to be imminent as assessed by the NICU attending physician
- Is currently enrolled in another study assessing the same and/or similar primary/secondary endpoints with/without drug treatment.
Sites / Locations
- Arkansas Cildren's Hospital
- Children's National Hospital
- South Miami Hospital
- Jamie Flores-Torres
- Matthew Butoryak
- UPMC Children's Hospital of Pittsburgh
- Marshall Health
- Jordan University of Science and Technology (King Abdullah University Hospital, KAUH)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Phenobarbital Sodium Injection 20mg
Phenobarbital Sodium Injection 40mg
Arm Description
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required).
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required).
Outcomes
Primary Outcome Measures
Neonates who do not require additional seizure treatment after the first dose of phenobarbital.
Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment.
Secondary Outcome Measures
Neonates who do not require additional seizure treatment after the first dose of phenobarbital.
Percent of neonates who do not require additional seizure treatment after 2 hours of the first dose of phenobarbital.
Neonates who do not require additional seizure treatment after the second dose of phenobarbital.
Percent of neonates who do not require additional seizure treatment after the second dose of phenobarbital within the first 24 hours of treatment.
Seizure burden
Seizure burden over 48 hours following initial administration of the phenobarbital injection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04320940
Brief Title
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Official Title
A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient participant recruitment hindered the study's progress, preventing robust data collection and compromising statistical power
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NEMA Research, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse effects, including death, placebo-controlled studies are not appropriate for this population. This study is designed to show intravenous phenobarbital is effective at preventing subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Benign Neonatal
Keywords
Neonatal Seizures, Phenobarbital, Anticonvulsants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phenobarbital Sodium Injection 20mg
Arm Type
Active Comparator
Arm Description
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required).
Arm Title
Phenobarbital Sodium Injection 40mg
Arm Type
Active Comparator
Arm Description
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required).
Intervention Type
Drug
Intervention Name(s)
Phenobarbital Sodium Injection
Other Intervention Name(s)
Phenobarbital
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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 2 hours of the first dose of phenobarbital.
Time Frame
2 hours
Title
Neonates who do not require additional seizure treatment after the second dose of phenobarbital.
Description
Percent of neonates who do not require additional seizure treatment after the second dose of phenobarbital within the first 24 hours of treatment.
Time Frame
24 hours
Title
Seizure burden
Description
Seizure burden over 48 hours following initial administration of the phenobarbital injection.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
44 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female neonates with a gestational age of ≥ 34 - ≤44 weeks admitted into the NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral hemorrhage, central nervous system infection)
Parental informed consent (in-person or remote consent)
Undergoing continuous video electroencephalogram (cvEEG) monitoring
Has evidence of electrographic seizure burden of at least 30 seconds/h
Exclusion Criteria:
Received anticonvulsant treatment, including phenobarbital, prior to randomization (with exception of lorazepam administered for sedation > 24 hours before enrollment)
Strong suspicion or confirmed diagnosis of brain malformation, inborn error of metabolism genetic syndrome, or major congenial malformation prior to randomization
Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic disorder
Death appears to be imminent as assessed by the NICU attending physician
Is currently enrolled in another study assessing the same and/or similar primary/secondary endpoints with/without drug treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Pergolizzi Jr., MD, MD
Organizational Affiliation
NEMA Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Cildren's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
South Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Jamie Flores-Torres
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Matthew Butoryak
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Marshall Health
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Jordan University of Science and Technology (King Abdullah University Hospital, KAUH)
City
Irbid'
ZIP/Postal Code
22110
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.
Learn more about this trial
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
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