Comparison of melatonin with clobazam as prophylactic agents from recurrent febrile seizures, a randomized clinical trial
Design
Clinical trial with a control group, with parallel groups, unblinded, non-randomized, phase 3 on 60 patients
Settings and conduct
In Bahrami Children's Hospital, Tehran, to investigate the effect of two drugs for the prophylaxis of febrile seizure
Participants/Inclusion and exclusion criteria
Inclusion criteria: The age of six months to 5 years and presenting with the second febrile seizure
Exclusion criteria: History of receiving medication for prophylaxis, History of epilepsy or other neurological disorders
Intervention groups
Intervention group: Children aged 6 to 60 months with two simple febrile seizures who received melatonin during the first 48 hours of febrile illness.
Control group: Children aged 6 to 60 months with two simple febrile seizures who received clobazam during the first 48 hours of febrile illness.
Main outcome variables
The recurrence of subsequent attacks of simple febrile seizures; Identification of drug side effects
General information
Reason for update
Acronym
FC
IRCT registration information
IRCT registration number:IRCT20221102056380N1
Registration date:2023-08-26, 1402/06/04
Registration timing:retrospective
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Nahid Khosroshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7301 3000
Email address
n_khosroshahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
2020-10-01, 1399/07/10
Actual recruitment end date
2022-03-20, 1400/12/29
Trial completion date
2022-03-20, 1400/12/29
Scientific title
Comparing the effectiveness of melatonin and clobazam in the prophylaxis of febrile seizures
Public title
Comparing the effectiveness of melatonin and clobazam in the prophylaxis of febrile seizures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged Twelve months to 5 years
It is the patient's second febrile seizure
Exclusion criteria:
History of receiving medication for prophylaxis
History of epilepsy or other neurological disorders
History of developmental delay
Age
From 12 months old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee of Children's Medical Center, Tehran University of Medical Sciences
Street address
No. 62, Children's Medical Center, Dr. Gharib St., End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2020-12-26, 1399/10/06
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.168
Health conditions studied
1
Description of health condition studied
Febrile Seizure
ICD-10 code
R56.00
ICD-10 code description
Simple febrile convulsions
Primary outcomes
1
Description
The recurrence of subsequent attacks of simple febrile seizures
Timepoint
6 and 12 months after the start of the intervention in children with febrile seizures
Method of measurement
Questions from parents
2
Description
Identification of drug side effects
Timepoint
6 and 12 months after the start of the intervention in children with febrile seizures
Method of measurement
Questions from parents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During the first 48 hours of febrile illness, melatonin at the dose of 0.3 mg/kg is given orally to children every 8 hours. The melatonin tablet contains 3 mg of the active substance, manufactured by Razak Iran.
Category
Prevention
2
Description
Control group: In the first 48 hours of febrile illness, clobazam is given orally to children every 12 hours. The dose of clobazam is adjusted based on the child's weight (less than 5 kg: one quarter of a tablet, 5 to 10 kg: one half of a tablet, 10 to 15 kg: three quarters of a tablet and more than 15 kg one tablet). Clobazam tablets contain 10 mg of active ingredient, manufactured by Hakim Iran.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami Children’s Hospital
Full name of responsible person
Nahid Khosroshahi
Street address
Damavand St
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Fax
+98 21 7756 9809
Email
n_khosroshahi@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Tehran University of Medical Sciences, corner of Qods St., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nahid Khosroshahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Bahrami Children's Hospital, Damavand St
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Fax
+98 21 7756 8809
Email
n_khosroshahi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nahid Khosroshahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Bahrami Children's Hospital, Damavand St
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Fax
+98 21 7756 8809
Email
n_khosroshahi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nahid Khosroshahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Bahrami Children's Hospital, Damavand St
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Fax
+98 21 7756 8809
Email
n_khosroshahi@tums.ac.ir
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 further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document