Investigating the Effect of Intermittent Oral Anticonvulsant Levetiracetam in Prevention of Recurrence of Fever and Convulsion in Children: a clinical trial study
The Effect of Intermittent Oral Anticonvulsant Levetiracetam in Prevention of Recurrence of Fever and Convulsion in Children
Design
This study is a non-blind clinical trial in a parallel design and with a control group. The study population will include all children aged 6 to 60 months with fever and seizures referred to Mohammad Kermanshahi Hospital of Kermanshah. 108 eligible children will be selected conveniently. Random table are used for randomization and participants are assigned to two groups of intervention and control.
Settings and conduct
This study, which will be performed in Mohammad Kermanshahi Hospital of Kermanshah, has not been blinded and all the parents of the participants and researchers are aware of the interventions received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 6 to 60 months; History of fever and seizures at least once
Exclusion criteria: Patients with immunodeficiency; Neurological disorder and abnormal neurological examination; Seizures due to infection of the central nervous system and developmental disorder or progressive nervous disease;
Intervention groups
The intervention group will receive only one dose of levetiracetam 30-60 mg (orally), in case of recurrence of fever and seizures, will receive for 9 months. The control group was given acetaminophen only to reduce fever for 9 months.
Main outcome variables
Fever, Convulsions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N170
Registration date:2021-06-21, 1400/03/31
Registration timing:registered_while_recruiting
Last update:2021-06-21, 1400/03/31
Update count:0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Intermittent Oral Anticonvulsant Levetiracetam in Prevention of Recurrence of Fever and Convulsion in Children: a clinical trial study
Public title
The Effect of Intermittent Oral Anticonvulsant Levetiracetam in Prevention of Recurrence of Fever and Convulsion in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 6 to 60 months
History of fever and seizures at least once
Exclusion criteria:
Patients with immunodeficiency
Neurological disorder and abnormal neurological examination
Seizures due to infection of the central nervous system and developmental disorder or progressive nervous disease
Age
From 6 months old to 60 months old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 54. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-02-16, 1399/11/28
Ethics committee reference number
ir.kums.rec.1400.075
Health conditions studied
1
Description of health condition studied
Neonatal seizure
ICD-10 code
P90
ICD-10 code description
Convulsions of newborn
Primary outcomes
1
Description
Fever
Timepoint
At the beginning of the study, once a month for 9 months
Method of measurement
By asking the child's parents and the number of hospital visits
2
Description
Convulsions
Timepoint
At the beginning of the study, once a month for 9 months
Method of measurement
By asking the child's parents and the number of hospital visits
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive only one dose of levetiracetam 30-60 mg (orally), in case of recurrence of fever and seizures, will receive for 9 months.
Category
Treatment - Drugs
2
Description
The control group was given acetaminophen only to reduce fever for 9 months (Dosage based on weight 30 to 60 mg per kilogram of body weight).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Javad Shabani
Street address
Helal Ahmar Crossroads, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8204
Email
javadshabani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@mbrc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Javad Shabani
Position
Resident Children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Helal Ahmar Crossroads, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8204
Email
javadshabani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mostafa Sedighi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Helal Ahmar Crossroads, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
009837218204
Email
sedighi_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Javad Shabani
Position
Resident Children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Helal Ahmar Crossroads, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
009837218204
Email
javadShabani@yahoo.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