Treating Wheezing in Children With Hypertonic Saline (TWICS)

Study 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

Official Title
-----------------
Treating Wheezing in Children With Hypertonic Saline (TWICS)

Conditions
-----------------
Wheeze

Intervention / Treatment
-----------------
* Other: hypertonic saline
* Other: saline


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypertonic saline<br>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). | Other: hypertonic saline<br>* inhaled nebulized 3%NaCl<br>* Other names: aerosolized hypertonic saline;|
| Active Comparator: saline<br>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). | Other: saline<br>* inhaled nebulized 0.9% NaCl<br>* Other names: aerosolized saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of admission to hospital | Rates of admission to hospital | duration of hospital ER stay, an average of 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early childhood, asthma, bronchiolitis, infection triggered, wheeze