HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL

Acute Viral Bronchiolitis. Clinical Trial

Official title:

HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00729274
• Other study ID #: 222207
• Status: Withdrawn
• Phase: N/A
• First received: August 5, 2008
• Last updated: September 4, 2015
• Start date: November 2011
• Est. completion date: April 2014

Study information

• Verified date: September 2015
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Viral Bronchiolitis.
• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Drug:
• normal saline solution
Two 4ml nebulizations with 30 minute interval

Locations

Country	Name	City	State
Canada	Laval University Hospital Center	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR), Centre de Recheche du Centre Hospitalier Université Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization Rate		After 48 hours of treatment in the emergency department	No
Secondary	The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement.		30 minutes after each nebulization	No