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Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG

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ClinicalTrials.gov Identifier: NCT03107507
Recruitment Status : Unknown
Verified March 2017 by Yara Salah Shaheen, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Yara Salah Shaheen, Cairo University

Tracking Information
First Submitted Date  ICMJE February 22, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date April 11, 2017
Actual Study Start Date  ICMJE March 25, 2017
Estimated Primary Completion Date October 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden. [ Time Frame: 72 hours ]
    Number of seizures before and after levetiracetam administration in comparison to phenobarbital.
  • Efficacy of levetiracetam in rapid control of neonatal seizures compared to phenobarbital. [ Time Frame: 72 hours ]
    Number of hours taken to achieve seizure freedom after administration of levetiracetam versus phenobarbital.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • Dose escalation data about levetiracetam through studying the efficacy of further dose administration in non responders. [ Time Frame: 72 hours ]
    Number of originally non responder participants who achieved seizure control with higher doses of levetiracetam.
  • Adequacy of levetiracetam as a single agent antiepileptic drug in control of neonatal seizures. [ Time Frame: 30 days ]
    Number of participants who require addition of second line antiepileptic drug to control seizures after levetiracetam versus phenobarbital use.
  • Accuracy of amplitude integrated EEG monitoring in detecting neonatal seizures before and after antiepileptic drug use. [ Time Frame: 48 hours ]
    Number of seizures detected by aEEG before and after antiepileptic drug use.
  • Effect of levetiracetam on aEEG background activity of participants. [ Time Frame: 48 hours ]
    Number of participants with normalization of background activity after administration of levetiracetam versus phenobarbital.
  • The short term clinical outcome of patients with neonatal seizures after treatment with levetiracetam. [ Time Frame: 3 months ]
    Neurodevelopmental assessment through detecting presence of following milestones:
    1. Head control
    2. Social smile
    3. Visual fixation and pursuit
    4. Turning towards sounds
  • The short term electroencephalographic outcome of patients with neonatal seizures after treatment with levetiracetam [ Time Frame: 3 months ]
    Number of participants with presence of epileptogenic activity on follow up electroencephalogram.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 5, 2017)
To gather safety information on levetiracetam use in neonates [ Time Frame: 72 hours ]
By collecting data of renal and liver function tests 48-72 hours after treatment.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG
Official Title  ICMJE Efficacy of Levetiracetam in Control of Neonatal Seizures
Brief Summary

Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as, levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal population, offering the potential for seizure treatment with a significantly better side-effect profile.

Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has been in clinical use for almost a decade in adults and older children with good efficacy, an excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved and used for treatment of seizures in infants starting one month of age since 2012.

The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a first-line drug in control of neonatal seizures. The investigators monitor the efficacy through assessment of frequency of seizures before and after drug administration, amplitude integrated EEG changes in background activity and seizure frequency in participants, duration taken for participants to be seizure free and short term neurodevelopmental outcome and EEG at 3 months of age

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Neonatal Seizures
Intervention  ICMJE
  • Drug: Levetiracetam
    Given in a bolus dose first 50mg/kg as levetiracetam reaches a therapeutic serum level rapidly in 1.3 hours. Titration will not be attempted in our study to reach drug level rapidly and consequent rapid effective control of seizures. Maintenance dose is then given at a dose of 10 - 40mg/kg/day divided every 12 hours.
  • Drug: Phenobarbital
    Phenobarbital is given intravenously in the form of a loading dose of 15mg/kg that can be repeated after a 20 minute interval not to exceed 30mg/kg then a maintenance dose 2-4 mg/kg/day divided every 12 hours.
Study Arms  ICMJE
  • Active Comparator: Levetiracetam

    Levetiracetam given in oral form via oro-gastric tube, first a bolus dose 40-50mg/kg then maintenance dose 10-30 mg/kg/day divided every 12 hours.

    Duration: until seizure free

    Intervention: Drug: Levetiracetam
  • Active Comparator: Phenobarbital

    Phenobarbital given in IV form, loading dose 20mg/kg that can be repeated after a 20 minute interval not to exceed 40mg/kg then maintenance dose 2-4 mg/kg/day divided every 12 hours.

    Duration: until seizure free

    Intervention: Drug: Phenobarbital
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2017
Estimated Primary Completion Date October 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All full term neonates experiencing seizures due to; post-hypoxic or post-ischemic encephalopathy, intracerebral hemorrhage, cerebral infection, inborn errors of metabolism or malformations of cortical development

Exclusion Criteria:

  • Preterm neonates
  • Full term neonates with seizures due to metabolic derangements (hypoglycemia, hypocalcemia or hypomagnesemia)
  • Full term neonates with impaired renal functions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03107507
Other Study ID Numbers  ICMJE YSShaheen
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yara Salah Shaheen, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Omneya G Afify, MD Cairo University
Study Director: Iman F Iskander, MD Cairo University
Principal Investigator: Aliaa A Ali, MD Cairo University
Principal Investigator: Yara S Shaheen, MSc. Cairo University
Principal Investigator: Walaa Shaarany, MD Cairo University
PRS Account Cairo University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP