Pharmacokinetics of Levetiracetam (Keppra) in Neonates

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

Conditions
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Seizures, Epilepsy

Intervention / Treatment
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* Drug: levetiracetam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with seizures<br> | Drug: levetiracetam<br>* Patients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile | 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 | 24 hours after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vital sign baseline | Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose. | 24 hours | 
| Number of participants with adverse events | Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seizures, epilepsy, neonatal, levetiracetam