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the effect of Nebulized Hypertonic3% Saline in the Treatment of Acute bronchiolitis in pediatric ward

Protocol summary

Summary
Objectives: Determination of effect of nebulized Hypertonic3% Saline in the Treatment of Acute bronchiolitis. Design: Double blind, control with placebo, single center, stage 2 trail. Setting and conduct: 70 acute bronchiolitis patients in Pediatric ward in Hajar Hospital in Shahrekord randomly assigned into two groups: experiment and control groups. Participants: Inclusion criteria are diagnosis of bronchiolitis, admission in Pediatric ward.exclusion criteria:any underlying disease (e.g., cystic fibrosis, bronchopulmonary dysplasia and cardiac or renal disease, wheezing, atopic dermatitis, allergic rhinitis or asthma, oxygen saturation (SaO2) <85% on room air, progressive respiratory failure requiring mechanical ventilation, previous treatment with bronchodilators, and any steroid therapy within 2 weeks. Interventions: Intervention group get nebulized Hypertonic3% Saline . The control group get nebulized ventolin for the same time with intervention group . Intervention period: Two weeks. main outcome measures: bronchiolitis symptoms

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012110510222N2
Registration date: 2013-01-28, 1391/11/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-01-28, 1391/11/09
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shahrekord University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of Nebulized Hypertonic3% Saline in the Treatment of Acute bronchiolitis in pediatric ward
Public title
the effect of Nebulized Hypertonic3% Saline in the Treatment of Acute bronchiolitis in pediatric ward
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of bronchiolitis, admission in Pediatric ward, Exclusion criteria:any underlying disease (e.g., cystic fibrosis, bronchopulmonary dysplasia and cardiac or renal disease, wheezing, atopic dermatitis, allergic rhinitis or asthma, oxygen saturation (SaO2) <85% on room air, progressive respiratory failure requiring mechanical ventilation, previous treatment with bronchodilators, and any steroid therapy within 2 weeks.
Age
To 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Ethics Committee, Shahrekord University of Medical Sciences, Kashani Street
City
Shahrekord
Postal code
Approval date
2013-01-08, 1391/10/19
Ethics committee reference number
24-10-91

Health conditions studied

1

Description of health condition studied
brochiolitis
ICD-10 code
J21.0
ICD-10 code description
Acute bronchiolitis due to respiratory syncytial virus

Primary outcomes

1

Description
bronchiolitis symptom
Timepoint
at base line, two weeks later
Method of measurement
examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 2 weeks,get hypersalin 3%.
Category
Treatment - Drugs

2

Description
Control group:2weeks,get ventolin
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital Shahrekord
Full name of responsible person
Zahra Keivani
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahrekord Univrsity of Medical Sciences
Full name of responsible person
Dr. Mahmoud Mobasheri
Street address
Vice Chancellor for Research, Shahrekord University of Medical Sciences, Kashani Street
City
Shahrekord
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, Shahrekord Univrsity 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
Shahrekord University Of Medical Sciences
Full name of responsible person
Zahra Keivani
Position
Master of Nursing
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University Of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
keivaniz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Zamani
Position
Assist Professor
Other areas of specialty/work
Street address
Shahrekord,Shahrekord University Of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
zamani.m@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Zahra Keivani
Position
Master Of Nursing
Other areas of specialty/work
Street address
Shahrekord,Shahrekord University Of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
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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