Treating Wheezing in Children With Hypertonic Saline (TWICS)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Wheeze
- Sponsor
- Dr. Michael Flavin
- Primary Endpoint
- Rates of admission to hospital
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
the brief summary captures the essence of the study
Investigators
Dr. Michael Flavin
Professor of Pediatrics
Queen's University
Eligibility Criteria
Inclusion Criteria
- •Age under 6 years
- •History of viral upper respiratory infection within previous 7 days
- •Wheezing or crackles detected on chest auscultation
- •Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.
Exclusion Criteria
- •History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
- •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
- •Use of nebulized HS within previous 12 hours
- •Presence of active varicella infection.
Outcomes
Primary Outcomes
Rates of admission to hospital
Time Frame: duration of hospital ER stay, an average of 4 hours
Rates of admission to hospital
Secondary Outcomes
- 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)
- Length-of-stay in the ED in the subgroup of patients not admitted(an average of 6 hours)
- Cumulative dose of bronchodilator administered in ED prior to admission/discharge order(an average of 6 hours)
- Rate of return visit to ED (for respiratory illness) within 14 days of enrollment(14 days)
- Length of hospital stay in the those who are admitted(length of hospital stay, an average of 3 days)