HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL
Primary Purpose
Acute Viral Bronchiolitis.
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
normal saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Acute Viral Bronchiolitis.
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of viral bronchiolitis
- Age 6 weeks to 12 months
- Clinical Score IRAS >3 and <8
Exclusion Criteria:
- prematurity <30 weeks
- younger than 6 weeks of age
- chronic lung disease
- immunosuppression.
- History of wheezing or asthma.
- Clinical Score IRAS >9
- parents refuse study
Sites / Locations
- Laval University Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
hypertonic saline solution
nebulized normal saline solution
Arm Description
Hypertonic Saline 3% solution alone.
2 nebulisation with 30 minute interval (max 4ml)
Outcomes
Primary Outcome Measures
Hospitalization Rate
Secondary Outcome Measures
The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement.
Full Information
NCT ID
NCT00729274
First Posted
August 5, 2008
Last Updated
September 4, 2015
Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR), Centre de Recheche du Centre Hospitalier Université Laval
1. Study Identification
Unique Protocol Identification Number
NCT00729274
Brief Title
HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL
Official Title
HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Was not approved by funding organization
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR), Centre de Recheche du Centre Hospitalier Université Laval
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (placebo). We hypothesise that patients with bronchiolitis who receive nebulized hypertonic saline solution will have less respiratory distress, less duration of symptoms and therefore less risk of being hospitalized than those receiving normal saline solution.
Detailed Description
Acute viral bronchiolitis is the principal lower respiratory tract infection in infants worldwide, 10% of canadian infants are affected each year. It is characterized by a first episode of difficulty to breathe, preceded by symptoms of fever, rhinorrhea and cough. The only accepted treatment for bronchiolitis is nasal cleaning, hydration and oxygen administration. Multiple studies have documented variation in diagnostic testing, clinical scores used and different treatment modalities. This suggests a lack of consensus on the diagnosis, on criteria for hospitalization and on treatment. Nebulized 3% hypertonic saline solution has been proposed as a potential treatment for the reduction in the severity of respiratory symptoms and the rate of admission in bronchiolitis, it has never been studied alone and the effect on the rate of admission has been little studied.
We propose a randomized double blind multicenter clinical trial on infants 6 weeks to 12 months old with moderate or severe bronchiolitis, in 9 emergency departments of hospitals situated in different provinces across Canada, during 3 winter seasons. We hypothesise that infants with bronchiolitis treated with nebulized hypertonic 3% saline solution would have less risk of being hospitalized and would have shorter and less intense respiratory symptoms than those infants treated with nebulized normal saline solution. Our principal objective is to determine if nebulized 3% hypertonic saline solution reduces admission rate 48 hours after treatment compared to placebo. Secondary objectives are to compare between groups intensity of respiratory symptoms measured by different clinical scores (RDAI,PRAM, PASS and IRAS), duration of symptoms, length of hospital stay, added secondary effects and subsequent office visits for the same problem.
Comparatively to other therapies already studied such as (dexamethasone and epinephrine), hypertonic 3% saline constitutes an interesting choice due to the absence of potential secondary effects. Our study will try to optimize the utilization of hospital resources involved in the treatment of bronchiolitis. Infants suffering from this disease could therefore profit from better treatments which will be reflected in a better condition, life quality and consequently those of their parents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Viral Bronchiolitis.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypertonic saline solution
Arm Type
Active Comparator
Arm Description
Hypertonic Saline 3% solution alone.
Arm Title
nebulized normal saline solution
Arm Type
Placebo Comparator
Arm Description
2 nebulisation with 30 minute interval (max 4ml)
Intervention Type
Drug
Intervention Name(s)
normal saline solution
Other Intervention Name(s)
Physiologic saline solution
Intervention Description
Two 4ml nebulizations with 30 minute interval
Primary Outcome Measure Information:
Title
Hospitalization Rate
Time Frame
After 48 hours of treatment in the emergency department
Secondary Outcome Measure Information:
Title
The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement.
Time Frame
30 minutes after each nebulization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of viral bronchiolitis
Age 6 weeks to 12 months
Clinical Score IRAS >3 and <8
Exclusion Criteria:
prematurity <30 weeks
younger than 6 weeks of age
chronic lung disease
immunosuppression.
History of wheezing or asthma.
Clinical Score IRAS >9
parents refuse study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guimont Chantal, MD, PhD.
Organizational Affiliation
Laval University Hospital Center, Quebec, Canada.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University Hospital Center
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL
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