- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01261416
Pharmacokinetics of Levetiracetam (Keppra) in Neonates
Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Infants with seizures
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic profile
Time Frame: 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 |
24 hours after dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vital sign baseline
Time Frame: 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.
|
24 hours
|
Number of participants with adverse events
Time Frame: 24 hours
|
Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.
|
24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101335-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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