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

Neonatal Seizures Clinical Trial

Official title:

Efficacy of Levetiracetam in Control of Neonatal Seizures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03107507
• Other study ID #: YSShaheen
• Status: Recruiting
• Phase: Phase 4
• First received: February 22, 2017
• Last updated: April 5, 2017
• Start date: March 25, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: Yara S Shaheen, Msc
• Phone: 01227981313
• Email: yarasalah.shaheen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Seizures
• Seizures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo University Children's Hospital (Abulreesh)	Cairo Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To gather safety information on levetiracetam use in neonates	By collecting data of renal and liver function tests 48-72 hours after treatment.	72 hours
Primary	Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden.	Number of seizures before and after levetiracetam administration in comparison to phenobarbital.	72 hours
Primary	Efficacy of levetiracetam in rapid control of neonatal seizures compared to phenobarbital.	Number of hours taken to achieve seizure freedom after administration of levetiracetam versus phenobarbital.	72 hours
Secondary	Dose escalation data about levetiracetam through studying the efficacy of further dose administration in non responders.	Number of originally non responder participants who achieved seizure control with higher doses of levetiracetam.	72 hours
Secondary	Adequacy of levetiracetam as a single agent antiepileptic drug in control of neonatal seizures.	Number of participants who require addition of second line antiepileptic drug to control seizures after levetiracetam versus phenobarbital use.	30 days
Secondary	Accuracy of amplitude integrated EEG monitoring in detecting neonatal seizures before and after antiepileptic drug use.	Number of seizures detected by aEEG before and after antiepileptic drug use.	48 hours
Secondary	Effect of levetiracetam on aEEG background activity of participants.	Number of participants with normalization of background activity after administration of levetiracetam versus phenobarbital.	48 hours
Secondary	The short term clinical outcome of patients with neonatal seizures after treatment with levetiracetam.	Neurodevelopmental assessment through detecting presence of following milestones: Head control; Social smile; Visual fixation and pursuit; Turning towards sounds	3 months
Secondary	The short term electroencephalographic outcome of patients with neonatal seizures after treatment with levetiracetam	Number of participants with presence of epileptogenic activity on follow up electroencephalogram.	3 months