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

May 4, 2007 updated by: Sheikh Khalifa Medical City

Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada
        • Victoria General Hospital
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 51900
        • Sheikh Khalifa Medical City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Length of stay.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Khalifa Medical City

Investigators

  • Principal Investigator: Brian A Kuzik, MD, FRCP, Sheikh Khalifa Medical City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2007

Last Update Submitted That Met QC Criteria

May 4, 2007

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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