Wheeze Clinical Trial
— TWICSOfficial title:
Treating Wheezing in Children With Hypertonic Saline (TWICS)
Verified date | January 2014 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used
in bronchodilator therapy for acute viral wheezing in all children under age 6 years will
provide superior symptom relief leading to decreased admission rates from the Emergency
Department.
The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered
with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group)
in a prospective, double blind, randomized controlled, multi-centre clinical trial of
children under age 6 years presenting to the ED with acute viral-associated wheezing.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 6 Years |
Eligibility |
Inclusion Criteria: 1. Age under 6 years 2. History of viral upper respiratory infection within previous 7 days 3. Wheezing or crackles detected on chest auscultation 4. Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air. Exclusion Criteria: 1. History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks. 2. Severe illness at presentation as defined by any of the following - respiratory rate greater than 80/min - SaO2 less than 88% in room air - need for assisted ventilation 3. Use of nebulized HS within previous 12 hours 4. Presence of active varicella infection. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Michael Flavin |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of admission to hospital | Rates of admission to hospital | duration of hospital ER stay, an average of 4 hours | No |
Secondary | Improvement in respiratory distress scores after initial protocol treatment in the ED | Improvement in respiratory distress scores after initial protocol treatment in the ED | time from pre-intervention assessment to post-intervention assessment, an average of 2 hours | No |
Secondary | Length-of-stay in the ED in the subgroup of patients not admitted | Length-of-stay in the ED in the subgroup of patients not admitted | an average of 6 hours | No |
Secondary | Cumulative dose of bronchodilator administered in ED prior to admission/discharge order | Cumulative dose of bronchodilator administered in ED prior to admission/discharge order | an average of 6 hours | No |
Secondary | Length of hospital stay in the those who are admitted | Length of hospital stay in the those who are admitted | length of hospital stay, an average of 3 days | No |
Secondary | Rate of return visit to ED (for respiratory illness) within 14 days of enrollment | Rate of return visit to ED (for respiratory illness) within 14 days of enrollment | 14 days | No |
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