Protocol summary

Study aim
Determining the effect of inhaled beta2 agonist (Ventolin) in the treatment of bronchiolitis
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 80 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The study will be conducted at Shahid Beheshti Hospital in Kashan and will continue until discharge from the hospital. Finally, the patients were divided into 2 groups. Standard treatment group: supportive treatment including oxygen and serum therapy is prescribed. Intervention group B: participants in this group, in addition to supportive therapy such as oxygen supplementation and receiving serum, are treated with a salbutamol nebulizer of 0.15 mg/kilogram of body weight. The production of GSK company, which will be prepared in coordination with the hospital pharmacy, will be given once every 20 minutes for an hour and then every 4 hours along with routine treatment. Participants, researchers, and outcome assessors were blinded in this study.
Participants/Inclusion and exclusion criteria
Entry criteria: age less than 2 years; Exit criteria: who will not be hospitalized due to the low severity of the disease Age less than 1 month or more than 2 years Immunodeficiency Congenital heart,lung disease Severe and mild severity of the disease
Intervention groups
The participants in this group, in addition to supportive treatment such as oxygen supplementation and receiving serum, are treated with a salbutamol nebulizer of 0.15 mg per kilogram of body weight produced by GSK nebulizers, which will be prepared in coordination with the hospital pharmacy, first once every 20 minutes until One hour and then every 4 hours along with routine treatment
Main outcome variables
Respiratory rate, blood oxygen saturation, whizzing, retraction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230413057899N1
Registration date: 2023-12-20, 1402/09/29
Registration timing: registered_while_recruiting

Last update: 2023-12-20, 1402/09/29
Update count: 0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
mahsa sadat nezam taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5545 3757
Email address
m.nezamtaheri1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of inhaled beta2 agonist (Ventolin) in the treatment of bronchiolitis in children
Public title
the effect of Ventolin in the treatment of bronchiolitis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age less than 2 years
Exclusion criteria:
Patients who will not be hospitalized due to the low severity of the disease Immunodeficiency Congenital heart disease Congenital lung disease Severe and mild severity of the disease
Age
From 1 month old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in blocks and a table will be prepared by computer and Excel software. The blocks will be binary combinations of AB, BA, BB, and AA, where each of the letters A and B will indicate standard treatment and Ventolin treatment, respectively. The patients were finally divided into 2 groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients receive their treatment (intervention or control group) while receiving oxygen therapy (Ventolin nebulizers in hospital-grade nebulizer masks), which are coded. Coding is done by one of the colleagues of the project, and the doctor, evaluator, and patient are blinded to how the patients are coded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Medicine & Faculty of Dentistry- Kashan University of Medic
Street address
56 Hekmat, Qutb Rawandi Boulevard, Kashan, Isfahan Province
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.109

Health conditions studied

1

Description of health condition studied
Bronchiolitis
ICD-10 code
J21
ICD-10 code description
Acute bronchiolitis

Primary outcomes

1

Description
Respiratory rate
Timepoint
1 hour and a half after starting the study
Method of measurement
Physical examination

2

Description
oxygen saturation
Timepoint
1 hour and a half after starting the study
Method of measurement
Pulse oximetry device

3

Description
Whizzing
Timepoint
1 hour and a half after starting the study
Method of measurement
Physical examination

4

Description
Retraction
Timepoint
1 hour and a half after starting the study
Method of measurement
Physical examination

Secondary outcomes

1

Description
Length of hospitalization
Timepoint
end of study
Method of measurement
number of days

Intervention groups

1

Description
The participants in this group, in addition to supportive treatment such as oxygen supplementation and receiving serum, are treated with a salbutamol nebulizer 0.15 mg per kilogram of body weight produced by GSK nebulizers, which will be prepared in coordination with the hospital pharmacy, first once every 20 minutes until One hour and then every 4 hours along with routine treatment
Category
Treatment - Drugs

2

Description
Control group: supportive treatment including oxygen therapy and serum therapy is prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mehsa Sadat Nezam Taheri
Street address
Allameh Qutb Ravandi Blvd, Kashan, Isfahan Province,
City
kashan
Province
Isfehan
Postal code
87159 88111
Phone
+98 31 5554 0026
Email
m.nezamtaheri1369@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Allameh Qutb Ravandi Blvd, Kashan,Isfahan Province
City
kashan
Province
Isfehan
Postal code
87159 88111
Phone
+98 31 5554 0026
Email
m.nezamtaheri1369@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mahsa sadat Nezam taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
22 bahman ave. tohid 9 str. no.5
City
Kashan
Province
Isfehan
Postal code
87159 88111
Phone
+98 31 5545 3757
Fax
Email
m.nezamtaheri1369@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahsa sadat Nezam taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
22 bahman ave. tohid 9 str. no.5
City
Kashan
Province
Isfehan
Postal code
87159 88111
Phone
+98 31 5545 3757
Fax
Email
m.nezamtaheri1369@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahsa sadat Nezam taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
22 bahman ave. tohid 9 str. no.5
City
Kashan
Province
Isfehan
Postal code
87159 88111
Phone
+98 31 5545 3757
Fax
Email
m.nezamtaheri1369@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Confirming the activities of researchers in academic and scientific institutions
From where data/document is obtainable
Mehsa Sadat Nizam Taheri m.nezamtaheri1369@gmail.com
What processes are involved for a request to access data/document
Formal request for access to data after 6 months of publication of the study The data will be sent to the sent email within one month after the request
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