The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants. - Full Text View

Sponsored by:	Sheikh Khalifa Medical City
Information provided by:	Sheikh Khalifa Medical City
ClinicalTrials.gov Identifier:	NCT00151905

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 II Phase III

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Ages Eligible for Study:	up to 18 Months
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	RC-09
Study First Received:	September 7, 2005
Last Updated:	May 4, 2007
ClinicalTrials.gov Identifier:	NCT00151905
Health Authority:	United Arab Emirates: General Authority for Health Services for Abu Dhabi

Keywords provided by Sheikh Khalifa Medical City:

bronchiolitis
hypertonic saline

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Bronchiolitis
Bronchitis

Additional relevant MeSH terms:

Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009