Treating Wheezing in Children With Hypertonic Saline (TWICS)

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2013

Detailed Description

the brief summary captures the essence of the study

Interventions

  • Other: hypertonic saline
    • inhaled nebulized 3%NaCl
  • Other: saline
    • inhaled nebulized 0.9% NaCl

Arms, Groups and Cohorts

  • 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).
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Rates of admission to hospital
    • Time Frame: duration of hospital ER stay, an average of 4 hours
    • Rates of admission to hospital

Secondary Measures

  • Improvement in respiratory distress scores after initial protocol treatment in the ED
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: an average of 6 hours
    • Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
  • Length of hospital stay in the those who are admitted
    • Time Frame: length of hospital stay, an average of 3 days
    • Length of hospital stay in the those who are admitted
  • Rate of return visit to ED (for respiratory illness) within 14 days of enrollment
    • Time Frame: 14 days
    • Rate of return visit to ED (for respiratory illness) within 14 days of enrollment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr. Michael Flavin
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr. Michael Flavin, Professor of Pediatrics – Queen’s University
  • Overall Official(s)
    • Michael Flavin, Principal Investigator, Queen’s University

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