Neonatal Seizures | Efficacy of Intravenous Levetiracetam in Neonatal Seizures
Neonatal Seizures research study
What is the primary objective of this study?
A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.
Who is eligible to participate?
Inclusion Criteria: 1. Newborns admitted to any of the study sites with electrographic seizures seizures. 2. Term infants gestational age >36 weeks less than 2 weeks of age. 3. Greater than 2200 grams. 4. Infants for whom parental consent to participate in the study is obtained. Exclusion Criteria: 1. Infants who are already receiving anticonvulsants 2. If serum creatinine is greater than 1.6mM 3. If seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia) 4. Subjects in whom death seems imminent, as assessed by the neonatologist.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Intravenous levetiracetamIntravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.
Drug:Intravenous phenobarbitalIntravenous load of phenobarbital (20 to 40 mg/kg)following EEG confirmation of seizure activity load.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Intravenous levetiracetamIntravenous levetiracetam 40 to 60 mg/kg loading dose. 10 mg/kg 8 hourly maintenance
Intravenous phenobarbitalIntravenous phenobarbital 20 to 40 mg/kg load. 1.5 mg/kg 8 hourly maintenance
Start Date: March 2013
Completed Date: September 2017
Phase: Phase 1/Phase 2
Primary Outcome: To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy compared to phenobarbital
Secondary Outcome: To obtain dose escalation data by studying the additional efficacy of a further dose in non responders.
Study sponsors, principal investigator, and references
Principal Investigator: Richard H Haas, MD
Lead Sponsor: Richard H. Haas
Collaborator: University of California, San Diego
Sharpe CM, Capparelli EV, Mower A, Farrell MJ, Soldin SJ, Haas RH. A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in pharmacokinetics occur during the first week of life. Pediatr Res. 2012 Jul;72(1):43-9. doi: 10.1038/pr.2012.51. Epub 2012 Apr 11.