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The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151905
First Posted: September 9, 2005
Last Update Posted: May 7, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheikh Khalifa Medical City
  Purpose
Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully used to treat other types of lung disease in children and adults. The purpose of this study is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more quickly.

Condition Intervention Phase
Bronchiolitis Drug: 3 % hypertonic saline Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants

Further study details as provided by Sheikh Khalifa Medical City:

Primary Outcome Measures:
  • Length of stay.

Study Start Date: November 2003
Estimated Study Completion Date: September 2006
Detailed Description:

Bronchiolitis is a common illness in infants and is associated with a significant morbidity. Standard therapy is controversial and largely ineffective; care is mostly supportive although nebulized medications continue to be commonly used. These medications are typically mixed with normal saline to produce a sufficient volume for efficient nebulization.

Inhaled hypertonic saline has been used to aid airway clearance in children with cystic fibrosis. It has also been used, in low dose, in two small studies in children with bronchiolitis. The current study is a randomized, double-blind, placebo-controlled, multi-center trial comparing frequent dosing with 3% hypertonic saline compared to normal saline in the treatment of infants hospitalized with bronchiolitis.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Corrected age maximum 18 months, plus
  • History of preceding viral upper respiratory tract infection, plus
  • Presence of wheezing and/or crackles on auscultation, plus
  • Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater, or oxygen saturation of 93% or less in room air, plus
  • Admitted to hospital

Exclusion Criteria:

  • Prior history of wheezing, or
  • History of chronic cardiopulmonary disease or immunodeficiency, or
  • Critical illness at presentation requiring admission to ICU, or
  • Use of nebulized hypertonic saline within previous 12 hours, or
  • Prematurity (gestational age 34 weeks or less).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151905


Locations
Canada, British Columbia
Victoria General Hospital
Victoria, British Columbia, Canada
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
United Arab Emirates
Sheikh Khalifa Medical City
Abu Dhabi, United Arab Emirates, 51900
Sponsors and Collaborators
Sheikh Khalifa Medical City
Investigators
Principal Investigator: Brian A Kuzik, MD, FRCP Sheikh Khalifa Medical City
  More Information

ClinicalTrials.gov Identifier: NCT00151905     History of Changes
Other Study ID Numbers: RC-09
First Submitted: September 7, 2005
First Posted: September 9, 2005
Last Update Posted: May 7, 2007
Last Verified: September 2005

Keywords provided by Sheikh Khalifa Medical City:
bronchiolitis
hypertonic saline

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections