Treating Wheezing in Children With Hypertonic Saline (TWICS)

NCT01868932 | Withdrawn Phase 2 DMC

• 2 other identifiers: TWICSHSTWICS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Wheeze

Keywords

wheeze; early childhood; asthma; bronchiolitis; infection triggered

Outcome Measures

Primary Outcomes (1)

• Rates of admission to hospital

  Rates of admission to hospital

  duration of hospital ER stay, an average of 4 hours

Secondary Outcomes (5)

• 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

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

  an average of 6 hours

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

  an average of 6 hours

• Length of hospital stay in the those who are admitted

  length of hospital stay, an average of 3 days

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

  14 days

Study Arms (2)

hypertonic saline

EXPERIMENTAL

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).

Other: hypertonic saline

saline

ACTIVE COMPARATOR

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).

Other: saline

Interventions

hypertonic saline OTHER

inhaled nebulized 3%NaCl

Also known as: nebulized hypertonic saline, aerosolized hypertonic saline

hypertonic saline

saline OTHER

inhaled nebulized 0.9% NaCl

Also known as: nebulized saline, aerosolized saline

saline

Eligibility Criteria

• Age: 2 Days - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age under 6 years
• History of viral upper respiratory infection within previous 7 days
• Wheezing or crackles detected on chest auscultation
• Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.

You may not qualify if:

• History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
• 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
• Use of nebulized HS within previous 12 hours
• Presence of active varicella infection.

Sponsors & Collaborators

• Dr. Michael Flavin: lead

MeSH Terms

Conditions

Respiratory Sounds; Asthma; Bronchiolitis

Interventions

Saline Solution, Hypertonic; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchitis; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael Flavin

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 5, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 13, 2015

Record last verified: 2014-01