Treating Wheezing in Children With Hypertonic Saline (TWICS)

Wheeze Clinical Trial

— TWICS  

Official title:

Treating Wheezing in Children With Hypertonic Saline (TWICS)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01868932
• Other study ID #: TWICS
• Secondary ID: HSTWICS
• Status: Withdrawn
• Phase: Phase 2
• First received: May 28, 2013
• Last updated: November 12, 2015
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

the brief summary captures the essence of the study

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wheeze

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Michael Flavin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of admission to hospital	Rates of admission to hospital	duration of hospital ER stay, an average of 4 hours	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No