Status:
TERMINATED
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Lead Sponsor:
NEMA Research, Inc.
Conditions:
Epilepsy, Benign Neonatal
Eligibility:
All Genders
34-44 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04320940
Start Date
March 12 2021
End Date
February 1 2023
Last Update
October 26 2023
Active Locations (8)
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1
Arkansas Cildren's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
3
South Miami Hospital
Miami, Florida, United States, 33143
4
Jamie Flores-Torres
Tampa, Florida, United States, 33606