Dosing of Levetiracetam (Keppra) in Neonates
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2010 |
| End Date: | July 2011 |
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.
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.
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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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