Acute Bronchiolitis Clinical Trial
— HSOfficial title:
7% Hypertonic Saline for Acute Bronchiolitis: A Randomized Controlled Trial
Verified date | June 2013 |
Source | Le Bonheur Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research suggests that hypertonic saline may improve mucous flow in infants with acute bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% hypertonic saline has not been previously investigated. OUr hypothesis was that 7% hypertonic saline would improve bronchiolitis severity scores and admission rate.
Status | Completed |
Enrollment | 101 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Weeks to 2 Years |
Eligibility |
Inclusion Criteria: - Patients age 6 weeks to = 18 months - Diagnosed with bronchiolitis (defined as viral respiratory illness and first episode of wheeze) - BSS score of = 4 Exclusion Criteria: - A previous history of wheezing; - diagnosis of asthma; - any use of bronchodilators within 2 h of presentation - gestational age = 34 weeks - history of congenital heart disease - chronic pulmonary or chronic renal disease - oxygen saturation of = 85% at the time of recruitment - severe disease requiring intensive care unit admission - inability to obtain informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Le Bonheur Children's Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Le Bonheur Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Bronchiolitis Severity Score | Bronchiolitis severity scores were recorded prior to administering aerosols, after administering the aerosol, and again once the treating clinician determined the final disposition of the patient. After a 4-h observation period, the treating clinician determined patient disposition. If admitted, the patient continued to receive aerosols containing the same designated medication every 6 h until discharge or 24 h after the admission. Bronchiolitis severity scores were obtained before and after each treatment. |
Baseline and up to 24 hours of hospital stay | |
Secondary | Admission rate | Secondary outcome measures included hospitalization rate, discharge rate at 23 h (observation status), and length of hospital stay. These are a composite of measures reflecting impact of hypertonic saline on in-patient metrics | For approximately 2 yrs, the duration of the study |
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