HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL

NCT ID: NCT00729274

Last Updated: 2015-09-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-04-30

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.

Conditions

Acute Viral Bronchiolitis.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

hypertonic saline solution

Hypertonic Saline 3% solution alone.

Group Type: ACTIVE_COMPARATOR

normal saline solution

Intervention Type: DRUG

Two 4ml nebulizations with 30 minute interval

nebulized normal saline solution

2 nebulisation with 30 minute interval (max 4ml)

Group Type: PLACEBO_COMPARATOR

normal saline solution

Intervention Type: DRUG

Two 4ml nebulizations with 30 minute interval

Interventions

normal saline solution

Two 4ml nebulizations with 30 minute interval

Intervention Type: DRUG

Other Intervention Names

Physiologic saline solution

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Centre de Recheche du Centre Hospitalier Université Laval

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Pediatric Research Unit of Laval University Hospital Center.

Principal Investigators

Guimont Chantal, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Laval University Hospital Center, Quebec, Canada.

Locations

Laval University Hospital Center

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

222207

Identifier Type: -

Identifier Source: org_study_id