Dosing of Levetiracetam (Keppra) in Neonates

Brief Summary

Official Title: “Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2011

Interventions Used in this Clinical Trial

  • Drug: levetiracetam
    • 50 mg/kg single loading dose of IV levetiracetam

Outcome Measures for this Clinical Trial

Primary Measures

  • Pharmacokinetic Profile
    • Time Frame: 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)
      Safety Issue?: No

Secondary Measures

  • Change in Vital Sign Baseline
    • Time Frame: 24 hours after loading dose
      Safety Issue?: Yes
  • Number of Participants With Adverse Events
    • Time Frame: 24 hours after dose
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 30 Days

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Children’s Hospital Medical Center, Cincinnati
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephanie Merhar, MD, Assistant Professor – Children’s Hospital Medical Center, Cincinnati
  • Overall Official(s)
    • Stephanie Merhar, MD, Principal Investigator, Children’s Hospital Medical Center, Cincinnati

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01239212