Comparison of phenobarbital effects with topiramate and lutiracetam in the treatment of neonatal seizures.
Comparison of the effect of phenobarbital with topiramate in neonatal seizure dermatitis.
Comparison of the effect of phenobarbital with levothyracetan in neonatal seizure dermatitis.
Comparison of the effect of topiramate with lutiracetam in neonatal seizure dermatitis.
Design
The research method is clinical practice with parallel groups, one-way blind and simple random
Settings and conduct
This research is performed by clinical practice in Tabriz Children's Hospital.
The research is semi-experimental and one-way blind, and parents have no knowledge of drug comparisons.
Participants/Inclusion and exclusion criteria
Entry criteria: All infants who have been referred to a medical center due to seizures. Exclusion criteria: If factors other than seizures are seen in the baby.
Intervention groups
First, three groups of children with seizures will be randomly selected by computer randomization and 10-40 mg / kg / state and 5 mg / kg / day of bifurcation for one oral phenobarbital-based intervention group. Oral topiramate will be 3-8 mg / kg / day and for the third group, 10-40 mg / kg / day Lotirastam-based intervention will be performed.
Main outcome variables
Used the effect of drugs on the treatment of various types of seizures and reduce the number of seizures and the greater the effectiveness on seizure symptoms and effective treatment of seizures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046137N1
Registration date:2020-08-05, 1399/05/15
Registration timing:prospective
Last update:2020-08-05, 1399/05/15
Update count:0
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
Shahram Sadeghvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2280
Email address
sadeghvandsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of phenobarbital, topiramate and levotiracetam in the treatment of neonatal seizure
Public title
The effect of phenobarbital, topiramate, and levothiracetam on neonatal seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infants who had seizures after birth
Exclusion criteria:
Babies who were hospitalized for other reasons, such as apnea or thrush
Age
From 1 day old to 28 days old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
From the simple random method and the sequential assignment of each newborn to a group of drugs, this simple random method will continue for each group of 20 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher is aware of the division of groups, and the parents have received explanations about the research, but they are not aware of the division of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Daneshgah street, Ethics Committee of Tabriz University of Medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5157664988
Approval date
2020-01-07, 1398/10/17
Ethics committee reference number
IR.TBZMED.REC.1398.1071
Health conditions studied
1
Description of health condition studied
Neonatal seizures
ICD-10 code
P90
ICD-10 code description
Convulsions of newborn
Primary outcomes
1
Description
Seizure type
Timepoint
Every month
Method of measurement
Clinical history
2
Description
Frequent seizures
Timepoint
Every month
Method of measurement
Clinical history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Phenobarbital 15mg tablet of Hayan Company with a dose of 5mg / kg / day / bid
Category
Treatment - Drugs
2
Description
Oral Topiramate tablets 25 mg by Hayan Company with a dose of 3 mg / kg / day / bid
Category
Treatment - Drugs
3
Description
Oral Lothirastam Syrup 100 mg / Hayan Company with a dose of 20 mg / kg / day / bid
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Dr. Mir Hadi Mousavi
Street address
Sheshgelan Street, Tabriz Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5157664988
Phone
+98 41 3526 2256
Email
sadeghvandsh@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Daneshgah Street, Research Vice-Chancellor of Tabriz university of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
10
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Leila Islamian Ghadim
Position
Children's resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Children Hospital, Seshghelaan St., Seggat ol Eslam Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5157664988
Phone
+98 41 3333 6335
Email
l.eslamiyan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahram Sadeghvand
Position
Pediatric neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children Hospital, Seshghelaan St., Seggat ol Eslam Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
Email
shahram.sadeghvand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Leila Islamian Ghadim
Position
Children's resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Children Hospital, Seshghelaan St., Seggat ol Eslam Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5157664988
Phone
+98 41 3333 6335
Email
L.ESLAMYAN@GMAIL.COM
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Use of medical findings and reputable scientific journals
When the data will become available and for how long
June 2021
To whom data/document is available
Instructors and medical journals
Under which criteria data/document could be used
For practical, therapeutic and scientific use
From where data/document is obtainable
Research Vice Chancellor of Tabriz University of Medical Sciences and reputable publications
What processes are involved for a request to access data/document