Treating Wheezing in Children With Hypertonic Saline (TWICS)

Dr. Michael Flavin

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.

the brief summary captures the essence of the study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Wheeze

Interventions

hypertonic salineOTHER

inhaled nebulized 3%NaCl

salineOTHER

inhaled nebulized 0.9% NaCl

Eligibility

Sex: ALLMin age: 2 DaysMax age: 6 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Rates of admission to hospital

Time frame: duration of hospital ER stay, an average of 4 hours

Secondary Outcomes

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

Length-of-stay in the ED in the subgroup of patients not admitted

Time frame: an average of 6 hours

Cumulative dose of bronchodilator administered in ED prior to admission/discharge order

Time frame: an average of 6 hours

Length of hospital stay in the those who are admitted

Time frame: length of hospital stay, an average of 3 days

Rate of return visit to ED (for respiratory illness) within 14 days of enrollment

Time frame: 14 days

Data from ClinicalTrials.gov

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