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Completed

NCT Number: NCT01261416

Pharmacokinetics of Levetiracetam (Keppra) in Neonates

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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Key information

Conditions

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

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2010
Registry last updated
Dec 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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