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

Further Study Details: 

Primary Outcomes: Length of stay.

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.

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

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).

Please refer to this study by ClinicalTrials.gov identifier  NCT00151905

Brian A Kuzik, MD, FRCP      971 2 610 2000  Ext. 2088    kuzbri741@skmc.gov.ae
Brian A Kuzik, MD, FRCP      971 2 610 2000  Ext. 2088    briankuzik@hotmail.com

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

Study chairs or principal investigators

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

Study ID Numbers:  RC-09
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151905
Health Authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi
ClinicalTrials.gov processed this record on 2005-09-13