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
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
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Seizures||Drug: Levetiracetam Drug: Phenobarbital||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy of Levetiracetam in Control of Neonatal Seizures|
|Actual Study Start Date :||March 25, 2017|
|Estimated Primary Completion Date :||October 30, 2017|
|Estimated Study Completion Date :||December 30, 2017|
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
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.
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
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.
- 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.
- 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:
- Head control
- Social smile
- Visual fixation and pursuit
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107507
|Contact: Yara S Shaheen, Msc||01227981313 ext firstname.lastname@example.org|
|Contact: Aliaa A Ali, MDemail@example.com|
|Cairo University Children's Hospital (Abulreesh)||Recruiting|
|Cairo Governorate, Egypt|
|Contact: Yara Shaheen|
|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|