Sezaby for Neonatal Seizures
What You Need to Know Before You Apply
What is the purpose of this trial?
This Phase 4, multicenter, single-arm, open-label study evaluates the effect of intravenous Sezaby (phenobarbital sodium) on electrocardiographic safety, including the QT interval, in neonates with seizures.
Are You a Good Fit for This Trial?
This trial is for newborns (neonates) who are having seizures. It focuses on babies who need treatment with Sezaby and can safely receive intravenous medication.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Sezaby (phenobarbital sodium)
Trial Overview
The study tests the safety of Sezaby (phenobarbital sodium) given through a vein, specifically looking at its effects on heart rhythms using ECG in newborns with seizures. All participants receive the same treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Neonates with seizures receiving intravenous Sezaby administered as loading dose(s) followed by maintenance dosing for up to 5 days according to the study protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sun Pharma Advanced Research Company Limited
Lead Sponsor
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