Epilepsy, Seizures
Conditions
Keywords
seizures, epilepsy, neonatal, levetiracetam
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.
Interventions
DRUGlevetiracetam
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed