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

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
3 % hypertonic saline
Sponsored by
Sheikh Khalifa Medical City
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring bronchiolitis, hypertonic saline

Eligibility Criteria

undefined - 18 Months (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Victoria General Hospital
  • Kingston General Hospital
  • Sheikh Khalifa Medical City

Outcomes

Primary Outcome Measures

Length of stay.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2005
Last Updated
May 4, 2007
Sponsor
Sheikh Khalifa Medical City
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1. Study Identification

Unique Protocol Identification Number
NCT00151905
Brief Title
The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.
Official Title
Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sheikh Khalifa Medical City

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, hypertonic saline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
3 % hypertonic saline
Primary Outcome Measure Information:
Title
Length of stay.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian A Kuzik, MD, FRCP
Organizational Affiliation
Sheikh Khalifa Medical City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria General Hospital
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Sheikh Khalifa Medical City
City
Abu Dhabi
ZIP/Postal Code
51900
Country
United Arab Emirates

12. IPD Sharing Statement

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

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