Treating Wheezing in Children With Hypertonic Saline (TWICS)
- Conditions
- Wheeze
- Interventions
- Other: hypertonic salineOther: saline
- Registration Number
- NCT01868932
- Lead Sponsor
- Dr. Michael Flavin
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hypertonic saline hypertonic saline inhalation of 4 ml nebulized study solution containing 3% hypertonic saline (HS, study group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes). saline saline inhalation of 4 ml nebulized study solution containing saline 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes).
- Primary Outcome Measures
Name Time Method Rates of admission to hospital duration of hospital ER stay, an average of 4 hours Rates of admission to hospital
- Secondary Outcome Measures
Name Time Method 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 Improvement in respiratory distress scores after initial protocol treatment in the ED
Length-of-stay in the ED in the subgroup of patients not admitted an average of 6 hours Length-of-stay in the ED in the subgroup of patients not admitted
Cumulative dose of bronchodilator administered in ED prior to admission/discharge order an average of 6 hours Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
Rate of return visit to ED (for respiratory illness) within 14 days of enrollment 14 days Rate of return visit to ED (for respiratory illness) within 14 days of enrollment
Length of hospital stay in the those who are admitted length of hospital stay, an average of 3 days Length of hospital stay in the those who are admitted