The aim of this study was to examine the efficacy of intravenous levetiracetam compared to oral Phenobarbital in a randomized clinical trial.
Design
Randomized Clinical trial using blocking methods with 50 individuals in each group, Two-sided blinding
Settings and conduct
legal guardianship and investigator of intervention results will ba blind
Participants/Inclusion and exclusion criteria
Infants with acute seizures need treatment with seizure management
Intervention groups
intravenous levetiracetam
Main outcome variables
Seizure, Count of Recurrent, drug side effects, treatment results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190526043717N1
Registration date:2019-05-31, 1398/03/10
Registration timing:prospective
Last update:2019-05-31, 1398/03/10
Update count:0
Registration date
2019-05-31, 1398/03/10
Registrant information
Name
Mansoureh Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3197 1125
Email address
safarim896@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous levetiracetam and phenobarbital for management of neonatal seizures
Public title
Comparison of intravenous levetiracetam and phenobarbital in neonatal seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
require for neonatal seizures management
Weight > 2500gr
birth age>37 weaks
Individuals without renal dysfunction
Individuals without dysfunction of the immune system
Exclusion criteria:
Healthy individuals
Weight <2500 gr
Birth age <37 weaks
renal dysfunction
immune system dysfunction
Age
From 1 day old to 12 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent, the random blocking method with a size of 4 will be allocated to each of the two treatment groups. Blocks will be determined randomly and using the PROC PLAN method in SAS 9.3 software by a biostatistician for the person who enters the study into the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
legal guardianship, as well as the investigator who measures the events related to intervention, will not be aware of the type of treatments, the coding method will be used to provide intervention, the code breaks will be available to the researcher after measuring the consequences as well as analysis of the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR-MUQ-REC
Street address
saheli
City
qom
Province
Ghoum
Postal code
3713649373
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
1397.210.IR.MUQ.REC
Health conditions studied
1
Description of health condition studied
Neonatal Seizures
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
seizures
Timepoint
30 min, 24 h up to 1 w, 1th m, 2th m, 3th m
Method of measurement
clinical observation
Secondary outcomes
1
Description
neonatal seizures recurrence
Timepoint
24 h up to 1 weak, first month, two month, and three month after intervention
Method of measurement
clinical observation
Intervention groups
1
Description
Intervention group: Levetiracetam intravenous 20-40 mg/kg/day, 15mg/kg/day per 12 h
Category
Treatment - Drugs
2
Description
Control group: Phenobarbital 20mg/kg two time a day, increasing dose up to 30mg/kg during 3 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrateh Masoumeh hospital
Full name of responsible person
Dr. Alireza Sadati
Street address
Emam
City
Qom
Province
Ghoum
Postal code
3719815539
Phone
+98 25 3665 1801
Email
masoumeh-hospital@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Hossein Sagafi
Street address
Saheli
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Email
dr.hosseinsaghafi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Alireza Sadati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Khorami Hospital, Emam Street
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3665 1801
Email
a-saadatimd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Alireza Sadati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Khorami Hospital, Emam Street
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3665 1801
Email
a-saadatimd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mansoureh Safari
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Saheli
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3197 1125
Fax
Email
safarim896@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The summarize information of samples will be published, so individual information remains secret.
When the data will become available and for how long
After 2019
To whom data/document is available
The ethics committee assessment team of Qom University of Medical Sciences
Under which criteria data/document could be used
For research aims as well as data quality assessment with considering the encoded information at the individual levels
From where data/document is obtainable
Dr. Alireza Saadati, Qom University of Medical Sciences, Qom, Iran
a-saadati md@yahoo.com
What processes are involved for a request to access data/document
Data Request Letter to the deputy of Research of Qom University of Medical Sciences and Dr. Alireza Saadati