Clinical trial NCT01475656: Efficacy of Keppra for Neonatal Seizures
Official title: Safety, Tolerability, and Efficacy of Levetiracetam for Neonatal Seizures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neonatal Seizures
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 2
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 neonates ≥ 35 weeks of gestation and ≤ 30 days of life with electrographically-confirmed seizures

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.


Eligibility 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

Primary outcomes:
measure: Efficacy
timeFrame: 24 hours
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 24 hours
measure: Safety
timeFrame: 7 days
measure: Tolerability
timeFrame: 6 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stephanie L Merhar, MD
role: PRINCIPAL_INVESTIGATOR
References: