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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Viral Bronchiolitis.
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Laval University Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: hypertonic saline solution; Hypertonic Saline 3% solution alone.	Drug: normal saline solution; Two 4ml nebulizations with 30 minute interval; Other Names: Physiologic saline solution
PLACEBO_COMPARATOR: nebulized normal saline solution; 2 nebulisation with 30 minute interval (max 4ml)	Drug: normal saline solution; Two 4ml nebulizations with 30 minute interval; Other Names: Physiologic saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospitalization Rate	After 48 hours of treatment in the emergency department

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Canadian Institutes of Health Research (CIHR); Centre de Recheche du Centre Hospitalier Université Laval
• Investigators: Principal Investigator: Guimont Chantal, MD, PhD., Laval University Hospital Center, Quebec, Canada.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ANTICIPATED): May 1, 2012
• Study Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 6, 2008
• First Posted (ESTIMATE): August 7, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 4, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Bronchiolitis, Viral; Pharmaceutical Solutions
• Other Study ID Numbers: 222207