Treating Wheezing in Children With Hypertonic Saline (TWICS) (TWICS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Wheeze
• Intervention / Treatment: Other: hypertonic saline; Other: saline

Detailed Description

the brief summary captures the essence of the study

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: hypertonic saline; inhaled nebulized 3%NaCl; Other Names: nebulized hypertonic saline; aerosolized hypertonic saline
Active Comparator: 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).	Other: saline; inhaled nebulized 0.9% NaCl; Other Names: nebulized saline; 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

Collaborators and Investigators

• Sponsor: Dr. Michael Flavin
• Investigators: Principal Investigator: Michael Flavin, Queen's University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 12, 2015
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: asthma; bronchiolitis; wheeze; early childhood; infection triggered
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: TWICS; HSTWICS (Other Identifier: Queen's Department of Pediatrics)