Efficacy of Keppra for Neonatal Seizures

NCT01475656 | Terminated DMC

• 1 other identifier: 2011-1557
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Seizures

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (3)

• Pharmacokinetics

  24 hours

• Safety

  7 days

• Tolerability

  6 months

Study Arms (2)

Levetiracetam as first line

Babies who receive levetiracetam as a first line drug for seizures

Drug: levetiracetam

Phenobarbital as first line

Babies who receive phenobarbital as a first line drug for seizures and levetiracetam as a second line drug

Drug: levetiracetam

Interventions

levetiracetam DRUG

Infants in the both groups will receive 50 mg/kg IV levetiracetam after (continued) seizures are EEG confirmed.

Levetiracetam as first line; Phenobarbital as first line

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

25 neonates ≥ 35 weeks of gestation and ≤ 30 days of life with electrographically-confirmed seizures

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie Merhar, MD: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45215, United States

Location

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephanie L Merhar, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

US (1)