Protocol summary

Summary
This study is designed to compare the effects of hypertonic saline 5 and 7% in the treatment of bronchiolitis in infants aged 2 months to 2 years. The study population will be 90 children aged 2 to 24 months with viral bronchiolitis admitted to Ardabil Buali hospital. Patients will be entered in this study with block randomization method of sampling and they will be divided into three groups of 30 people. This will be a double blind study namely both the subjects participating and the researchers will be unaware of medication type. Inclusion criteria are first or second episode of respiratory distress with wheezing and diagnosis of viral bronchiolitis based on the standard definition of bronchiolitis. Exclusion criteria are history of previous wheezing attacks more than 2 times, heart and lung disease, immunodeficiency, Down syndrome, metabolic diseases, use of mechanical ventilation, positive family history of asthma, and Patients who are critically ill. The first group will be treated with 0.15 mg/kg adrenaline along with hypertonic saline 5%, The second group will be treated with 0.15 mg/kg adrenaline along with hypertonic saline 7%, and the third group as the control group will be treated with the standard treatment, namely, 0.15 mg/kg adrenaline along with normal saline 0.9%. For all patients in the three groups, clinical symptoms (cough, wheezing, respiratory rate, heart rate, fever, crackles, oxygen saturation) and length of hospital stays will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090717843N5
Registration date: 2015-12-09, 1394/09/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-09, 1394/09/18
Registrant information
Name
Adel Ahadi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1773 1210
Email address
a.ahadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ardabil University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between effect of 5% and 7% saline on bronchiolitis treatment in infants
Public title
The comparison between effect of 5% and 7% saline on bronchiolitis treatment in infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: first or second episode of respiratory distress; wheezing; diagnosis of viral bronchiolitis based on the standard definition of bronchiolitis. Exclusion criteria: History of previous wheezing attacks more than 2 times; heart and lung disease; immunodeficiency; Down syndrome; metabolic diseases; use of mechanical ventilation; positive family history of asthma; and Patients who are critically ill.
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: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Research samples will be divided into three equal groups using block randomization method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, daneshgah Street, Ardabil.
City
Ardabil
Postal code
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.ARUMS.REC.1394.19

Health conditions studied

1

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

Primary outcomes

1

Description
Oxygen Saturation
Timepoint
Every 6 hours for 24 hours after admission, and then once a day until discharge
Method of measurement
Using pulse oximetry

2

Description
Respiratory rate
Timepoint
Every 6 hours for 24 hours after admission, and then once a day until discharge
Method of measurement
counting the number of breaths for one minute

3

Description
Heart rate
Timepoint
Every 6 hours for 24 hours after admission, and then once a day until discharge
Method of measurement
counting the number of heartbeats for one minute

4

Description
Fever
Timepoint
Every 6 hours for 24 hours after admission, and then once a day until discharge
Method of measurement
Using a thermometer

5

Description
Crackles
Timepoint
Every 6 hours for 24 hours after admission, and then once a day until discharge
Method of measurement
Examination

6

Description
cough duration
Timepoint
Every 6 hours for 24 hours after admission, and then once a day until discharge
Method of measurement
Patient observation and counting days till fully recover from cough

7

Description
Wheezing duration
Timepoint
Every 6 hours for 24 hours after admission, and then once a day until discharge
Method of measurement
Physical examination

8

Description
duration of hospital stay
Timepoint
Since the start of admission until discharge
Method of measurement
Counting the days of hospitalization

Secondary outcomes

empty

Intervention groups

1

Description
First group: 10 mL of 5% hypertonic saline with 0.15 mg/kg adrenaline
Category
Treatment - Drugs

2

Description
Second group: 10 mL of 7% hypertonic saline with 0.15 mg/kg adrenaline
Category
Treatment - Drugs

3

Description
Third group: standard treatment: 10 mL of 0.9% normal saline with 0.15 mg/kg adrenaline
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Dr Adel Ahadi
Street address
Bu-Ali Hospital, Saheli street, Ardabil
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardabil University of Medical Science, Daneshgah Street, Ardabil
City
Ardabil
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Fatemeh Amani
Position
Medical Resident
Other areas of specialty/work
Street address
Bu-Ali Hospital, Saheli street, Ardabil
City
Ardabil
Postal code
5613643197
Phone
+98 45 3373 1210
Fax
Email
eng.m.amani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences.
Full name of responsible person
Dr Adel Ahadi
Position
Pediatrics Specialist
Other areas of specialty/work
Street address
Bu-Ali Hospital, Saheli Street, Ardabil
City
Ardabil
Postal code
5613643197
Phone
+98 45 3373 1210
Fax
Email
a.ahadi@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Fatemeh Amani
Position
Medical Resident
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
eng.m.amani@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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