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

• Sponsor: Sheikh Khalifa Medical City (Other)
• Overall Status: Completed
• CT.gov ID: NCT00151905
• Collaborator: (none)
• Locations: 3
• Duration (Months): 34

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis	Drug: 3 % hypertonic saline	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants
• Study Start Date: Nov 1, 2003
• Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. Length of stay. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Victoria General Hospital	Victoria	British Columbia	Canada
2	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00151905
• Other Study ID Numbers: RC-09
• First Posted: Sep 9, 2005
• Last Update Posted: May 7, 2007
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: bronchiolitis; hypertonic saline
• Additional relevant MeSH terms: Bronchiolitis

Study Results

No Results Posted as of May 7, 2007