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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with seizures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levetiracetam | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vital sign baseline | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Infants ≥ 32 weeks gestation and ≤ 30 days of age requiring treatment with levetiracetam for clinical and/or electrographic seizures or seizure prophylaxis.
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Merhar, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.
| 24 hours |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |