Efficacy of Keppra for Neonatal Seizures
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: Neonatal Seizures
Intervention: levetiracetam (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Stephanie Merhar, MD Official(s) and/or principal investigator(s): Stephanie L Merhar, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
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.
Clinical Details
Official title: Safety, Tolerability, and Efficacy of Levetiracetam for Neonatal Seizures
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Efficacy
Secondary outcome: PharmacokineticsSafety Tolerability
Eligibility
Minimum age: N/A.
Maximum age: 30 Days.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45215, United States
Additional Information
Starting date: November 2011
Last updated: April 17, 2013
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