The aim of this study is comparison of intravenous Levetiracetam and phenobarbital for first line treatment of acute neonatal seizures
Design
The study design is clinical trial with control group, with parallel groups, not blinded and simple randomization method and patients will be studied in two groups of 25 cases.
Settings and conduct
In this not-blinded clinical trial, all neonates admitted to the neonatal intensive care unit of BuAli hospital of Sari due to seizure are evaluated.
Participants/Inclusion and exclusion criteria
Term neonates with age ≤ 28 days, clinical seizures requiring treatment based on the diagnosis of a neonatalologist or pediatric neurologist and obtaining written informed consent of parents are included
Intervention groups
In the intervention group, Levetiracetam made by Estragen Company, Switzerland with initial loading dose of 30 mg/kg with slow intravenous infusion is applied for 15 minutes and 10 mg/kg maintenance dose is used for 12 hours diluted with normal saline.
In the control group, Phenobarbital made by Pars Daroo company is injected with loading dose of 20 mg/kg, which is increased upto 40 mg/kg if seizure is not controlled.
Main outcome variables
The main outcomes of the study include seizures, frequency of seizures, drug side effects, and intervention outcome (seizure control in 30 minutes).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090412001808N7
Registration date:2020-01-24, 1398/11/04
Registration timing:retrospective
Last update:2020-01-24, 1398/11/04
Update count:0
Registration date
2020-01-24, 1398/11/04
Registrant information
Name
Ali Abbaskhanian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1223 3010
Email address
aabbaskhanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
2018-06-21, 1397/03/31
Actual recruitment end date
2019-05-21, 1398/02/31
Trial completion date
2019-06-22, 1398/04/01
Scientific title
Clinical trial of comparison of intravenous Levetiracetam and phenobarbital for first line treatment of acute neonatal seizures
Public title
The effect of Levetiracetam and phenobarbital in treatment of neonatal seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term neonates
Age ≤ 28 days
Clinical seizures requiring treatment based on the diagnosis of a neonatalologist
Seizure diagnosis based on pediatric neurologist diagnosis and EEG interpretation
Written informed consent of parents
Exclusion criteria:
Renal failure
Seizures caused by electrolyte disorders such as hypocalcemia and hypoglycemia
Patients whose seizures respond to vitamin B6 administration
Sensitivity to Levetiracetam or phenobarbital
Structure Anomaly
Asphyxia
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.MAZUMS.REC.1398.543
Health conditions studied
1
Description of health condition studied
Acute neonatal seizure
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Seizure
Timepoint
30 min, 24 hour up to 1 week, 1st month, 2nd month, 3rd month
Method of measurement
Clinical examination and observation of paroxysmal movements of the neonate
Secondary outcomes
1
Description
Sizure recurrence
Timepoint
30 min, 24 hour up to 1 week, 1st month, 2nd month, 3rd montt
Method of measurement
Clinical examination and observation
Intervention groups
1
Description
Intervention group: Levetiracetam made by Estragen Company, Switzerland with initial loading dose of 30 mg/kg with slow intravenous infusion is injected for 15 minutes and maintenance dose of 10 mg/kg for 12 hours diluted with normal saline. If the seizure is controlled, the injectable drug will gradually decrease and become orally administered at a maintenance dose of 5 mg/kg/day.
Category
Treatment - Drugs
2
Description
Control group: Phenobarbital drug produced by Pars Darou Company is injected at a loading dose of 20 mg/kg which can be increased up to 40 mg/kg if seizure is not controlled. If the seizure is stopped, the injectable drug will gradually decrease and become orally administered at a maintenance dose of 5 mg/kg/day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU of Bouli hospital of Sari
Full name of responsible person
Dr. Ali Abbaskhanian
Street address
Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Fax
+98 11 3334 2334
Email
snali45@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3334 2334
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ali Abbaskhanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bouali hospital, Pasdaran Blv, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
snali45@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ali Abbaskhanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
snali45@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Nayyerolsadat Tahami
Position
Pediatric Assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Buali hospital, Pasdaran Blv, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
dr.ns.tahami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data is shareable after people are unrecognizable
When the data will become available and for how long
Starting from April 2020
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
The data will be used for research and surveillance purposes, with the confidentiality of individuals' personal information
From where data/document is obtainable
Send email to Dr. Ali Abbaskhanian, snali45@yahoo.com
What processes are involved for a request to access data/document
Written Request from Research Deputy of Mazandaran University of Medical Sciences and Dr. Abbaskhanian