Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic profile
Study Overview
Brief Summary
The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 30 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gestational age ≥ 32 weeks
- •Postnatal age ≤ 30 days
- •Birth weight ≥ 2000 grams
- •Admitted to the NICU at Cincinnati Children's Hospital or Good Samaritan 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
Arms & Interventions
Infants with seizures
Intervention: levetiracetam (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic profile
Time Frame: 24 hours after dose
Blood specimens for quantitation of levetiracetam and its metabolite L057 will be obtained from an indwelling vascular catheter not used for study drug infusion or by heel stick in three different sampling schedules: Group 1 (n=6): at times 2-15 minutes after the end of infusion, 1-2 hours, and 12 hours post start of infusion Group 2 (n=6): at times 2-15 minutes after the end of infusion, 2-4 hours, and 18 hours post start of infusion Group 3 (n=6): at times 2-15 minutes after the end of infusion, 4-8 hours, and 20-24 hours post start of infusion
Secondary Outcomes
- Change in vital sign baseline(24 hours)
- Number of participants with adverse events(24 hours)