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Cincinnati, Ohio 45229


Purpose:

The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.


Criteria:

Inclusion Criteria: - Gestational age ≥ 32 weeks - Postnatal age ≤ 30 days - Birth weight ≥ 2000 grams - Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital - Clinical or electrographic seizures of any etiology - Seizures or seizure prophylaxis requiring treatment with levetiracetam - Parental consent obtained Exclusion Criteria: - Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time - Infants who have previously received levetiracetam - Parents refuse consent - Attending physician does not wish the infant to be enrolled in the study - Infants who are currently receiving an investigational drug


NCT ID:

NCT01239212


Primary Contact:

Principal Investigator
Stephanie Merhar, MD
Children's Hospital Medical Center, Cincinnati


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45229
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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