Protocol summary

Study aim
Evaluating the effect of oral diazepam on febrile seizures following pertussis vaccination
Design
Randomized clinical trials with control group, parallel group
Settings and conduct
The sampling is done in Emam Hossein Hospital, Isfahan. The intervention group is under treatment with diazepam tablet at a dose of 1 mg/kg daily as three times a day until 48 hours after vaccine injection and the control group is under treatment with rectal diazepam in initial of seizure with a dose of 0.5 mg/kg.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages more than one year and a history of febrile seizures. Exclusion criteria: Having contraindications for the pertussis vaccine, continuous usage of anticonvulsants in the child, and the parents' unwillingness to continue participation in this study.
Intervention groups
The intervention group: under treatment with diazepam tablet at a dose of 1 mg/kg daily as three times a day until 48 hours after vaccine injection. The control group: under treatment with rectal diazepam in initial of seizure with a dose of 0.5 mg/kg.
Main outcome variables
The incidence of fever and also seizure at the time after the injection of the pertussis vaccine

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130311012782N24
Registration date: 2018-11-02, 1397/08/11
Registration timing: retrospective

Last update: 2018-11-02, 1397/08/11
Update count: 0
Registration date
2018-11-02, 1397/08/11
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-06-03, 1394/03/13
Expected recruitment end date
2017-12-30, 1396/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral diazepam in febrile seizures following acellular pertussis vaccination
Public title
Effect of diazepam on seizures following fever
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 1 year History of febrile seizures
Exclusion criteria:
Having contraindications for the pertussis vaccine, including the occurrence of seizures following vaccine injecting Continuous usage of anticonvulsants in the child The parents' disinclination to continue participation in this study
Age
From 18 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are divided randomly into two intervention and control groups by random allocation software.
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 Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
IR.MUI.REC.1396.6064

Health conditions studied

1

Description of health condition studied
Febrile convulsions
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Numbers of seizure and fever
Timepoint
Third and seventh days after the injection of the vaccine
Method of measurement
By asking parents of patients

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Under treatment with diazepam tablet at a dose of 1 mg/kg daily as TID until 48 hours after vaccine injection.
Category
Prevention

2

Description
Control group: Under treatment with rectal diazepam in the initial of seizure at a dose of 0.5 mg/kg
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Rose Soltani
Street address
Emam Khomeyni
City
Isfahan
Province
Isfehan
Postal code
1435915371
Phone
+98 31 3386 6266
Email
rosesoltani@gmail.com
Web page address
http://ehuch.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr mansoor siavash
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8565458525
Phone
+98 31 3668 8597
Email
keyvanghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Rose Soltani
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
rosesoltani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Rose Soltani
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+31 36688597
Email
rosesoltani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
Msc/ head of research department
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
research department, Alzahra hospital, Isfahan
City
isfahan
Province
Isfehan
Postal code
8434193474
Phone
+31 33563466
Fax
+98 31 3669 2174
Email
mehrabi@mui.ac.ir
Web page address

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
No - There is not a plan to make this available
Title and more details about the data/document
Only the results of the whole data are made available to the public
When the data will become available and for how long
Starting 3 months after publication
To whom data/document is available
Information is provided to Isfahan University of Medical Sciences
Under which criteria data/document could be used
The use of data is merely intended to introduce the study and examine how the parameters are measured
From where data/document is obtainable
Dr. Rose Soltani (Project Manager) Address: Imam Hossein Hospital, Imam Khomeini St, Isfahan, Iran Tel: 00983136688597 Email: rosesoltani@gmail.com Mobile: 00989133023280
What processes are involved for a request to access data/document
1. No use these data in another study 2. Member of the Faculty of Medicine of Isfahan University of Medical Sciences 3. No data access to someone else
Comments
Loading...