Acute Viral Bronchiolitis. Clinical Trial
Official title:
HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment