In this study to reviewing the efficacy of Montelukast in prevention of upper respiratory infections in children whom did not have hyper reactive airway disease, 380 children 1 to 5 years referring to pediatric clinic of Amir Kabir hospital from December 2012 to February 2013, receiving Montelukast or placebo in ratio of one to one in a
double blind randomized method.The way is that they are referred to a third person who has placebo and montelukast and he give them placebo or montelukast randomly.A Form of primary information for them to be filled.Then be followed weekly by phone.In addition, each patient Receives a Symptom checklist that includes fever, rhinitis, cough, antipyretic or antibiotic use, physician visits, absences from kindergarten.Each patient will be followed for 12 weeks and during this time the number of attacks of upper respiratory infections are recorded.The data obtained from both cases and controls are compared in general and by age and sex with each other.If someone refuses to continue, he will be replaced by a new one.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012103111339N1
Registration date:2012-12-06, 1391/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Mohammad Hossein Esmaeli Sirchi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1422 1019
Email address
esmaelie.m@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Montelukast and placebo in the prevention of upper respiratory infections in children 1 to 5 years
Public title
Montelukast effect in the prevention of respiratory infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of hyper reactive airway disease;No history of allergic rhinitis;Not taking any medication for a chronic;Absence of chronic heart disease or chronic respiratory disease:
Exclusion criteria
Hyper reactive airway disease (previously treated with bronchodilators in the last three months, Or more than once treatment in the past year or hospitalization for treatment or prophylaxis in recent years with Monteluckast or steroids);History of allergic rhinitis;Taking any medication for a chronic; Chronic heart disease or chronic respiratory disease;Known hypersensitivity to Montelukast;Active URI within one week ago
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
380
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Pardis, Sardasht
City
Arak
Postal code
3848176941
Approval date
2012-06-27, 1391/04/07
Ethics committee reference number
91-128-13
Health conditions studied
1
Description of health condition studied
Common cold
ICD-10 code
j00
ICD-10 code description
Acute nasopharyngitis [common cold]
Primary outcomes
1
Description
Number of uri attacks
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom checklist
Secondary outcomes
1
Description
Otitis media, Pneumonia, Tonsillitis, Pharyngitis
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom cheklist
2
Description
The number of weeks that a child has a fever
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom cheklist
3
Description
The use of antibiotics or anti-fever
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom cheklist
4
Description
Doctor visits
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom cheklist
5
Description
Absences from child care
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom cheklist
6
Description
Absent parents
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom cheklist
7
Description
Hospitalization
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom cheklist
8
Description
Drug reaction
Timepoint
Weekly to 12 weeks
Method of measurement
Call and complete symptom cheklist
Intervention groups
1
Description
In this randomized, double-blind study 190 children from 1 to 5 years old referred to Pediatric Clinic of arak Amir Kabir Hospital from 21/11/2012 to 19/2/2013 who do not have hyper reactive airway disease get montelucast(5 mg daily) oral once a day and fills for them an information form then they followed by weekly calls.In addition, each patient Receives a record sheet of fever, rhinitis, cough, antipyretic or antibiotic use, the absence of child care and doctor visits.Each patient will be followed for 12 weeks.
Category
Prevention
2
Description
In this randomized, double-blind study 190 children from 1 to 5 years old referred to Pediatric Clinic of arak Amir Kabir Hospital from 21/11/2012 to 19/2/2013 who do not have hyper reactive airway disease get placebo oral once a day and fills for them an information form then they followed by weekly calls.In addition, each patient Receives a record sheet of fever, rhinitis, cough, antipyretic or antibiotic use, the absence of child care and doctor visits.Each patient will be followed for 12 weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir kabir Hospital
Full name of responsible person
Dr Fatemeh Dorreh
Street address
Amir Kabir Hospital, Alamolhoda St.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Saiid Changizi Ashtyani
Street address
Pardis, Sardasht
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Fatemeh Dorreh
Position
Assistant Professor
Other areas of specialty/work
Street address
Pardis, Sardasht
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 86 1313 5075
Email
esmaelie.m@arakmu.ac.ir
Web page address
www.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Fatemeh Dorreh
Position
Pediatrician
Other areas of specialty/work
Street address
Pardis, Sardasht
City
Arak
Postal code
3848176941
Phone
+98 86 1417 3638
Fax
+98 86 1313 5075
Email
esmaelie.m@arakmu.ac.ir
Web page address
www.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Esmaeli
Position
Pediatric Resident
Other areas of specialty/work
Street address
pardis, sardasht
City
Arak
Postal code
3848176941
Phone
+98 86 1313 5075
Fax
+98 86 1313 5075
Email
esmaelie.m@arakmu.ac.irdr_esmaeli@yahoo.com
Web page address
www.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)