Pharmacokinetics of Levetiracetam (Keppra) in Neonates

NCT01261416 | Completed

• 1 other identifier: 101335-2
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Seizures; Epilepsy

Keywords

seizures; epilepsy; neonatal; levetiracetam

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in vital sign baseline

  24 hours

• Number of participants with adverse events

  24 hours

Study Arms (1)

Infants with seizures

Drug: levetiracetam

Interventions

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.

Infants with seizures

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants ≥ 32 weeks gestation and ≤ 30 days of age requiring treatment with levetiracetam for clinical and/or electrographic seizures or seizure prophylaxis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephanie Merhar, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 16, 2010

Record last verified: 2010-12

Locations

US (1)