Treating Wheezing in Children With Hypertonic Saline (TWICS)

Dr. Michael Flavin

Status and phase: Withdrawn; Phase 2

Conditions: Wheeze

Treatments: Other: hypertonic saline; Other: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01868932

HSTWICS (Other Identifier)

TWICS

Details and patient eligibility

About

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.

Full description

the brief summary captures the essence of the study

Sex: All

Ages: 2 days to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

hypertonic saline

Experimental group

Description:

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).

Treatment:

Other: hypertonic saline

saline

Active Comparator group

Description:

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).

Treatment:

Other: saline