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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 Baseline

Number 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

Page last updated: August 23, 2015

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