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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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


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
See also
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