Treating Wheezing in Children With Hypertonic Saline (TWICS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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the brief summary captures the essence of the study

Conditions

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Wheeze

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

hypertonic saline

Intervention Type OTHER

inhaled nebulized 3%NaCl

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).

Group Type ACTIVE_COMPARATOR

saline

Intervention Type OTHER

inhaled nebulized 0.9% NaCl

Interventions

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hypertonic saline

inhaled nebulized 3%NaCl

Intervention Type OTHER

saline

inhaled nebulized 0.9% NaCl

Intervention Type OTHER

Other Intervention Names

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nebulized hypertonic saline aerosolized hypertonic saline nebulized saline aerosolized saline

Eligibility Criteria

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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.

Minimum Eligible Age

2 Days

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No