NCT Number: NCT00151905
The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
Up to 18 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Victoria General Hospital, Victoria, British Columbia, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Primary outcomes
-
Length of stay.
Sponsors and collaborators
Lead sponsor
Sheikh Khalifa Medical City
Other
Registry information
Official study title
Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants
Important dates
- Study start
- 2003
- Study completion
- 2006
- First posted
- Sep 9, 2005
- Registry last updated
- May 7, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Evaluation of the Impact of EHR-Alerts on Clinical Decision Support Pathway Use in Bronchiolitis, and the Impact of Pathway Use on the Prescription of High Flow Nasal Cannula and Other Elements of High Value Care.
NCT06932341
Bronchial Diseases, Bronchiolitis
St. Petersburg, Florida, United States
View Trial DetailsSafe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
NCT06016244
Bronchial Diseases, Bronchial Hyperreactivity
Haarlem, North Holland, Netherlands
View Trial DetailsComparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants
NCT02824744
Bronchial Diseases, Bronchiolitis
Montpellier, France
View Trial DetailsPeak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis
NCT03298217
Bronchial Diseases, Bronchiolitis
Montpellier, France
View Trial Details