Clinical Trial: HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL

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 Summary:

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 a
Sponsor: Laval University

Current Primary Outcome: Hospitalization Rate [ Time Frame: After 48 hours of treatment in the emergency department ]

Original Primary Outcome: Hospitalization Rate [ Time Frame: After two treatments in the emergency department ]

Current Secondary Outcome: The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement. [ Time Frame: 30 minutes after each nebulization ]

Original Secondary Outcome: The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement. [ Time Frame: 30,60,90 and 120 min ]

Information By: Laval University

Dates:
Date Received: August 5, 2008
Date Started: November 2011
Date Completion: April 2014
Last Updated: September 4, 2015
Last Verified: September 2015