Protocol summary

Summary
Evaluation of efficacy of combination of nebulized salbutamol with different concentration of saline (normal saline 0/9%, hypertonic saline 3%) in infant with bronchiolitis whom admitted in Ali Ebne Ab iTaleb hospital of Zahedan, Iran. Design: randomized, double blind, without control with placebo, unicentral, stage 3 of clinical trial on infant with bronchiolitis whom admitted in hospital (age 4 weeks up to 24 months) and require oxygen therapy. Inclusion criteria: age less than 2 year old; history of recent upper respiratory viral infection which caused wheeze and crackle in auscultation; CBSS 4-8 in admit. Exclusion criteria: age less than 1 month or more than 2 years old; history of recurrent attack of wheeze; sever neurological disorder; consolidation in Chest x ray; immune deficiency; congenital heart disease; history of premature (gestational age less than 34 weeks); birth weight less than 2500 gr; saturation of oxygen less than 85% in room; CBSS less than 4 or more than 8; unstable hemodynamic (heart rate more than 200 per minute,blood pressure 2 standard deviation more or less than normal range for age and sex, respiratory rate more than 70 per minute). Sample size:180; infants who have inclusion criteria and their respiratory rate is between 30-60 (moderate group) with method of random number table divided in 3 groups, each group has 60 person.group 1 receive 5 ml normal saline 0/9 % and 0/15 mg/kg nebulized salbutamol, group 2 receive 5 ml hypertonic saline 3% and 0/15 mg/kg nebulized salbutamol, group 3 receive 10 ml normal saline 0/9 % and 0/15 mg/kg nebulized saline, then clinical features, oxygen saturation, respiratory rate, heart rate, intercostal retraction, dyspnea and wheezing evaluated pretreatment and each 30 minutes after treatment up to 3 times.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022826809N1
Registration date: 2016-04-23, 1395/02/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-23, 1395/02/04
Registrant information
Name
Fariba Goodarzi
Name of organization / entity
Zahedan Medical University of Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5580
Email address
f.goodarzi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-02-04, 1393/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of combination of nebulized salbutamol with high concentration of saline (normal saline 0/9%, hypertonic saline 3%) in bronchiolitis
Public title
Comparing Therapeutic effects of combination of high volume normal saline and salbutamol nebulizer with combination of hypertonic saline 3% and salbutamol nebulizer in bronchiolitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age less than 2 year old; history of recent upper respiratory viral infection which caused wheeze and crackle in auscultation; CBSS 4-8 in admit. Exclusion criteria: age less than 1 month or more than 2 years old; history of recurrent attack of wheeze; sever neurological disorder; consolidation in Chest x ray; immune deficiency; congenital heart disease; history of premature (gestational age less than 34 weeks); birth weight less than 2500 gr; saturation of oxygen less than 85% in room; CBSS less than 4 or more than 8; unstable hemodynamic (heart rate more than 200 per minute, blood pressure 2 standard deviation more or less than normal range for age and sex, respiratory rate more than 70 per minute).
Age
From 1 month old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan Medical University of Science, Dr.Hesabi Square, Daneshgah Avenue, Zahedan
City
Zahedan
Postal code
Approval date
2014-06-28, 1393/04/07
Ethics committee reference number
IR.zaums.res.1393.6792

Health conditions studied

1

Description of health condition studied
Bronchiolitis
ICD-10 code
J20, J21,J
ICD-10 code description
Other acute lower respiratory infections

Primary outcomes

1

Description
Respiratory rate
Timepoint
Pretreatment and each 30 minute up to 3 times after the begining of treatment
Method of measurement
Counting respiratory rate in 1 minute

2

Description
O2 saturation
Timepoint
Pretreatment and each 30 minute up to 3 times after the begining of treatment
Method of measurement
Pulse oximetery

3

Description
Heart rate
Timepoint
Pretreatment and each 30 minute up to 3 times after the begining of treatment
Method of measurement
Counting heart rate in 1 minute

4

Description
Intercostal retraction
Timepoint
Pretreatment and each 30 minute up to 3 times after the begining of treatment
Method of measurement
Physical exam and score of CBSS (0,1,2,3)

5

Description
Dyspnea
Timepoint
Pretreatment and each 30 minute up to 3 times after the begining of treatment
Method of measurement
Physical exam and score of CBSS (0,1,2,3)

6

Description
Wheezing
Timepoint
Pretreatment and each 30 minute up to 3 times after the begining of treatment
Method of measurement
Physical exam and score of CBSS (0,1,2,3)

Secondary outcomes

empty

Intervention groups

1

Description
First group: receive 5 ml hypertonic saline 3% and 0.15 mg/kg nebulized salbutamol.
Category
Treatment - Drugs

2

Description
Second group: receive 5 ml normal saline 0.9% and 0.15 mg/kg nebulized salbutamol.
Category
Treatment - Drugs

3

Description
Third group: receive 10 ml normal saline 0.9% and 0.15 mg/kg nebulized salbutamol.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali-ebn Abi -Taleb Hospital, Zahedan
Full name of responsible person
Street address
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Hesabi Square, Zahedan
City
Zahedan
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,Zahedan 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
Zahedan Medical University
Full name of responsible person
Fariba Goodarzi
Position
Pediatric Residence
Other areas of specialty/work
Street address
Ali-ebn Abi Taleb Hospital,Salamat Blvd, Dr.Hesabi Sq.,Daneshgah Ave., Zahedan
City
Zahedan
Postal code
981674311
Phone
+98 54 3329 5580
Fax
Email
F.goodarzi@zaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan Medical University
Full name of responsible person
Fariba Goodarzi
Position
Pediatric Residence
Other areas of specialty/work
Street address
Ali Ebn Abitaleb Hospital, Salamt Blvd, Dr.Hesabi Sq., Daneshgah Ave.,Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5580
Fax
Email
f.goodarzi@zaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Goodarzi
Position
Pediatric Residence
Other areas of specialty/work
Street address
Ali-ebn Abi Taleb Hospital, Khalije Fars Blvd., Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5580
Fax
Email
f.goodarzi@zaums.ac.ir
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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