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

NCT ID: NCT00151905

Last Updated: 2007-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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3 % hypertonic saline

Intervention Type DRUG

Eligibility Criteria

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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).
Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheikh Khalifa Medical City

OTHER

Sponsor Role lead

Principal Investigators

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Brian A Kuzik, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Sheikh Khalifa Medical City

Locations

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Victoria General Hospital

Victoria, British Columbia, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Sheikh Khalifa Medical City

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Site Status

Countries

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Canada United Arab Emirates

Other Identifiers

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RC-09

Identifier Type: -

Identifier Source: org_study_id