Condition: Neonatal Seizure · Neonatal Encephalopathy · Hypoxic-Ischemic Encephalopathy · Sponsor: University of California, San Diego
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 20 minute seizure burden/hour. This will make the final results of study more generalizable. If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to rece…
This description comes directly from the study's public registry record.
Sonya G Wang, M.D. · 612-301-1454 · sgwang@umn.edu
Brittany Faanes, MPH · 612-625-5929 · grego318@umn.edu
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| University of California, San Diego | San Diego, California, United States | Recruiting |
| University of Minnesota | Minneapolis, Minnesota, United States | Recruiting |
| Auckland City Hospital | Auckland, Auckland, New Zealand | Recruiting |
| Middlemore Hospital | Auckland, Auckland, New Zealand | Recruiting |
| Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand | Wellington, Wellington Region, New Zealand | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05610085