An observational study in Neonatal Seizures, sponsored by Stephanie Merhar, MD. Terminated at 1 site in United States. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2013-04-19.
Sponsored by Stephanie Merhar, MD · Observational
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.
881 studies on the registry are indexed under Seizures; 144 are open to participants now.
This study's enrollment of 2 is below the median of 150 across 235 observational studies indexed under Seizures.
Browse Seizures studies →This is the only study on the registry with Stephanie Merhar, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
25 neonates ≥ 35 weeks of gestation and ≤ 30 days of life with electrographically-confirmed seizures
Exclusion criteria:
Babies who receive levetiracetam as a first line drug for seizures
Drug: levetiracetam
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.
Efficacy
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.
Time frame: 24 hours
Pharmacokinetics
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).
Time frame: 24 hours
Safety
Safety will be monitored by reviewing changes in vital signs and laboratory parameters after the dose.
Time frame: 7 days
Tolerability
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.
Time frame: 6 months
This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.