Dosing of Levetiracetam (Keppra) in Neonates
Information source: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seizures
Intervention: levetiracetam (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Children's Hospital Medical Center, Cincinnati Official(s) and/or principal investigator(s): Stephanie Merhar, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
Summary
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.
Clinical Details
Official title: Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetic Profile
Secondary outcome: Change in Vital Sign BaselineNumber of Participants With Adverse Events
Eligibility
Minimum age: N/A.
Maximum age: 30 Days.
Gender(s): Both.
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
Locations and Contacts
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States
Additional Information
Starting date: September 2010
Last updated: August 5, 2015
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