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Efficacy of Keppra for Neonatal Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01475656
Recruitment Status : Terminated (difficulty with recruitment)
First Posted : November 21, 2011
Last Update Posted : April 19, 2013
Information provided by (Responsible Party):
Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati

Brief Summary:

The purpose of this research study is to learn how well the medication levetiracetam (Keppra) works to treat seizures in full term and premature babies. Levetiracetam is commonly used in babies with seizures at Cincinnati Children's Hospital, especially if the seizures have not been stopped by other medicines. The Food and Drug Administration (FDA) has approved the use of levetiracetam for older children (over the age of 4) but not for infants. Even though it is not FDA approved for this age group, doctors at Cincinnati Children's use the medicine as a second drug in babies whose seizures are not stopped by phenobarbital. Some doctors are concerned that phenobarbital is not the best medicine to treat seizures in babies, so researchers are trying to study other medicines.

In this study, the investigators are looking at how well levetiracetam stops or slows down seizures in babies. The investigators are also studying the blood levels of levetiracetam to learn more about how the medicine is processed by the body and what level of medicine in the body works to stop seizures. The investigators are checking labs before and after giving the dose to make sure the medication does not cause any changes in blood counts, kidney function, or liver function. The investigators are following all of the babies in the study after hospital discharge to see if the parents notice any side effects of the medication. Babies in the study will come back to the High Risk Follow Up Clinic at Cincinnati Children's at 6 months of age for a visit with a neurologist and a neonatologist and developmental testing.

Condition or disease Intervention/treatment
Neonatal Seizures Drug: levetiracetam

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety, Tolerability, and Efficacy of Levetiracetam for Neonatal Seizures
Study Start Date : November 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort Intervention/treatment
Levetiracetam as first line
Babies who receive levetiracetam as a first line drug for seizures
Drug: levetiracetam
Infants in the both groups will receive 50 mg/kg IV levetiracetam after (continued) seizures are EEG confirmed.

Phenobarbital as first line
Babies who receive phenobarbital as a first line drug for seizures and levetiracetam as a second line drug
Drug: levetiracetam
Infants in the both groups will receive 50 mg/kg IV levetiracetam after (continued) seizures are EEG confirmed.

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 24 hours ]
    The primary outcome is the proportion of infants who achieve electrographic seizure freedom as measured by continuous EEG monitoring for 24 hours after intravenous levetiracetam administration.

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 24 hours ]
    Pharmacokinetic parameters and the concentration-response relationship will be determined by collecting 3 blood samples in the 24 hours after the dose (2-15 minutes post infusion, 1-2 hours post infusion, and 6-10 hours post infusion).

  2. Safety [ Time Frame: 7 days ]
    Safety will be monitored by reviewing changes in vital signs and laboratory parameters after the dose.

  3. Tolerability [ Time Frame: 6 months ]
    Infants who remain on levetiracetam after discharge will be followed for 6 months to determine post-hospital treatment-emergent adverse events. All infants in the study will receive a 6 month developmental profile using the Bayley Scales of Infant Development.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
25 neonates ≥ 35 weeks of gestation and ≤ 30 days of life with electrographically-confirmed seizures

Inclusion criteria:

  • Gestational age ≥ 35 weeks
  • Postnatal age ≤ 30 days
  • Birth weight ≥ 2000 grams
  • Clinical or electrographic seizures of any etiology requiring treatment with an antiepileptic medication (as per the judgment of the clinician caring for the patient)
  • Parental consent obtained

Exclusion criteria:

  • Infants with renal insufficiency indicated by serum creatinine > 2.0 (as part of pre-screening, labs obtained as part of routine care will be reviewed. Infants who have not had a creatinine drawn will have one drawn as part of the study after consent is obtained. If the baby requires levetiracetam emergently before the results of the creatinine are back, the dose will still be given and levels will still be drawn as per the protocol.
  • Infants who have previously received levetiracetam
  • Parents refuse consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01475656

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45215
Sponsors and Collaborators
Stephanie Merhar, MD
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Principal Investigator: Stephanie L Merhar, MD Children's Hospital Medical Center, Cincinnati

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Responsible Party: Stephanie Merhar, MD, Assistant Professor of Pediatrics, Children's Hospital Medical Center, Cincinnati Identifier: NCT01475656     History of Changes
Other Study ID Numbers: 2011-1557
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nootropic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers