The effect of Ventolin plus hypertonic saline and Ventolin alone on bronchiolitis recovery in patients 2 months to 2 years
Design
Clinical trial, without control group, with parallel groups, not blinded, randomized
Settings and conduct
The study included patients from 2 months to 2 years who are hospitalized in Amir hospital in Semnan, will be implemented. Patients are divided into two groups of 35 each. In the Ventolin group alone, patients receive Ventolin nebulized and in the other group, in addition to Ventolin nebulized , hypertonic saline is also prescribed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 2 months to 2 years old admitted to hospital with bronchiolitis diagnosis, personal consent, no other underlying illness and having wheezing for the first time.
Exclusion criteria include: history of asthma, no this medication used, course of corticosteroid use during and after treatment, and oxygen levels below 85% for 30 minutes.
Intervention groups
Patients are divided into two groups:
Ventolin group alone: There are 35 patients in this group who will receive Ventolin Nebulization 0.15 mg / kg up to 2.5 mg for 20 minutes every 6 hours for 5 days.
Ventolin group with hypertonic saline: There were 35 patients in this group who received Ventolin Nebulization 0.15 mg / kg up to 2.5 mg for 20 minutes every 6 hours for 5 days + 5cc NaCl 3% Nebulization for 20 minutes every 8 minutes for 5 days .
Main outcome variables
Duration of hospitalization, duration of respiratory distress symptoms, duration of wheezingم
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180119038433N2
Registration date:2020-02-29, 1398/12/10
Registration timing:registered_while_recruiting
Last update:2020-02-29, 1398/12/10
Update count:0
Registration date
2020-02-29, 1398/12/10
Registrant information
Name
Amin Izadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 5228
Email address
aminizadi1374@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ventolin plus hypertonic saline and Ventolin alone on bronchiolitis recovery in patients 2 months to 2 years
Public title
Ventolin plus hypertonic saline and Ventolin alone on bronchiolitis recovery in pediatrics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2 months to 2 years old
Bronchiolitis diagnosis
Hospitalization
Personal consent
No underlying illness
Having wheezing for the first time
Exclusion criteria:
Children with a history of asthma
Non-use of drugs in the course of the disease
Corticosteroid use during hospitalization and after medication use
For 30 minutes the oxygen saturation is lower than 85%
Age
From 2 months old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is a simple, individual and by random numbers.
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 Semnan University of Medical Sciences
Street address
Vice chancellor for research and technology, Semnan University of Medical Sciences, Basij Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.SEMUMS.REC.1398.269
Health conditions studied
1
Description of health condition studied
Bronchiolitis
ICD-10 code
J21.9
ICD-10 code description
Bronchiolitis (acute) (infective) (subacute)
Primary outcomes
1
Description
Duration of Respiratory Distress Symptoms
Timepoint
5 days after treatment
Method of measurement
Reduction of shortness of breath and no use of sub-muscles for breathing as measured by patient examination.
2
Description
Duration of wheezing
Timepoint
5 days after treatment
Method of measurement
Auscultation with a stethoscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Ventolin alone): There are 35 patients in this group who will receive Ventolin Nebulization 0.15 mg / kg up to 2.5 mg for 20 minutes every 6 hours for 5 days.
Category
Treatment - Drugs
2
Description
Intervention group (Ventolin group with hypertonic saline): There were 35 patients in this group who received Ventolin Nebulization 0.15 mg / kg up to 2.5 mg for 20 minutes every 6 hours for 5 days + 5cc NaCl 3% Nebulization for 20 minutes every 8 minutes for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir AL-momenin hospital of Semnan
Full name of responsible person
Mohammad Hosseini
Street address
Amir Al-momenin hospital, Shahid Mostafa Khomeini Avenue, Imam Hossein Square.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Fax
+98 23 3346 1580
Email
amirhos@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Koukhayi
Street address
Vice chancellor for research and technology, Semnan University of Medical Sciences, Basij Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Amir Al-momenin hospital, Shahid Mostafa Khomeini Avenue, Imam Hossein Square.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
abolfazlkazemi1357@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Amir Al-momenin hospital, Shahid Mostafa Khomeini Avenue, Imam Hossein Square.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
abolfazlkazemi1357@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Amir Al-momenin hospital, Shahid Mostafa Khomeini Avenue, Imam Hossein Square.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
abolfazlkazemi1357@gmail.com
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
Undecided - It is not yet known if there will be 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