Pharmacokinetics of Levetiracetam (Keppra) in Neonates

Completed

• Conditions: Seizures; Epilepsy
• Interventions: Drug: levetiracetam

• Registration Number: NCT01261416
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-12
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Last Update Submitted: 2010-12-15
• Study First Posted: 2010-12-16
• Last Update Posted: 2010-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants with seizures	levetiracetam	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile	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 Outcome Measures

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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States