HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL

This study has been withdrawn prior to enrollment.
(Was not approved by funding organization)
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Centre de Recheche du Centre Hospitalier Université Laval
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00729274
First received: August 5, 2008
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Acute Viral Bronchiolitis.
Drug: normal saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Hospitalization Rate [ Time Frame: After 48 hours of treatment in the emergency department ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement. [ Time Frame: 30 minutes after each nebulization ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: hypertonic saline solution
Hypertonic Saline 3% solution alone.
Drug: normal saline solution
Two 4ml nebulizations with 30 minute interval
Other Name: 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 Name: Physiologic 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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00729274

Locations
Canada
Laval University Hospital Center
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Laval University
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.
  More Information

No publications provided

Responsible Party: Dr. Chantal Guimont MD, PhD, Pediatric Research Unit of Laval University Hospital Center.
ClinicalTrials.gov Identifier: NCT00729274     History of Changes
Other Study ID Numbers: 222207
Study First Received: August 5, 2008
Last Updated: June 29, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014