The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants |
- Length of stay.
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | September 2006 |
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 |
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| 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 | |
| Principal Investigator: | Brian A Kuzik, MD, FRCP | Sheikh Khalifa Medical City |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00151905 History of Changes |
| Other Study ID Numbers: | RC-09 |
| Study First Received: | September 7, 2005 |
| Last Updated: | May 4, 2007 |
| Health Authority: | United Arab Emirates: General Authority for Health Services for Abu Dhabi |
Keywords provided by Sheikh Khalifa Medical City:
|
bronchiolitis hypertonic saline |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013