A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures (NEOLEV3)
Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy
About this trial
This is an interventional treatment trial for Neonatal Seizure
Eligibility Criteria
Inclusion Criteria: at risk for seizures or suspected to be having seizures; all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia; Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days); weight > 2200g. Exclusion Criteria: Cumulative seizure burden of 8 minutes/ hour or more in phases 1 and 2, Cumulative seizure burden of 30 minutes/hour or more in phase 3; Renal failure defined as anuria in the first 24 hours of life; Subjects in whom death seems imminent; Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.
Sites / Locations
- University of California, San Diego
- Auckland City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Dose escalation with LEV
Standard of care Phenobarbital
Additional LEV at a higher dose (30 mg/kg, 60 mg/kg, or 90 mg/kg depending on the stage of the study).
Treatment with Phenobarbital 20mg/kg IV and if needed a further 20mg/kg totalling 40mg/kg