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Treating Wheezing in Children With Hypertonic Saline (TWICS) (TWICS)

Primary Purpose

Wheeze

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
hypertonic saline
saline
Sponsored by
Dr. Michael Flavin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wheeze focused on measuring wheeze, early childhood, asthma, bronchiolitis, infection triggered

Eligibility Criteria

2 Days - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    hypertonic saline

    saline

    Arm 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).

    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).

    Outcomes

    Primary Outcome Measures

    Rates of admission to hospital
    Rates of admission to hospital

    Secondary Outcome Measures

    Improvement in respiratory distress scores after initial protocol treatment in the ED
    Improvement in respiratory distress scores after initial protocol treatment in the ED
    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
    Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
    Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
    Length of hospital stay in the those who are admitted
    Length of hospital stay in the those who are admitted
    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

    Full Information

    First Posted
    May 28, 2013
    Last Updated
    November 12, 2015
    Sponsor
    Dr. Michael Flavin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01868932
    Brief Title
    Treating Wheezing in Children With Hypertonic Saline (TWICS)
    Acronym
    TWICS
    Official Title
    Treating Wheezing in Children With Hypertonic Saline (TWICS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding declined. Study never initiated.
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr. Michael Flavin

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    the brief summary captures the essence of the study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wheeze
    Keywords
    wheeze, early childhood, asthma, bronchiolitis, infection triggered

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    hypertonic saline
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    saline
    Arm Type
    Active Comparator
    Arm 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).
    Intervention Type
    Other
    Intervention Name(s)
    hypertonic saline
    Other Intervention Name(s)
    nebulized hypertonic saline, aerosolized hypertonic saline
    Intervention Description
    inhaled nebulized 3%NaCl
    Intervention Type
    Other
    Intervention Name(s)
    saline
    Other Intervention Name(s)
    nebulized saline, aerosolized saline
    Intervention Description
    inhaled nebulized 0.9% NaCl
    Primary Outcome Measure Information:
    Title
    Rates of admission to hospital
    Description
    Rates of admission to hospital
    Time Frame
    duration of hospital ER stay, an average of 4 hours
    Secondary Outcome Measure Information:
    Title
    Improvement in respiratory distress scores after initial protocol treatment in the ED
    Description
    Improvement in respiratory distress scores after initial protocol treatment in the ED
    Time Frame
    time from pre-intervention assessment to post-intervention assessment, an average of 2 hours
    Title
    Length-of-stay in the ED in the subgroup of patients not admitted
    Description
    Length-of-stay in the ED in the subgroup of patients not admitted
    Time Frame
    an average of 6 hours
    Title
    Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
    Description
    Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
    Time Frame
    an average of 6 hours
    Title
    Length of hospital stay in the those who are admitted
    Description
    Length of hospital stay in the those who are admitted
    Time Frame
    length of hospital stay, an average of 3 days
    Title
    Rate of return visit to ED (for respiratory illness) within 14 days of enrollment
    Description
    Rate of return visit to ED (for respiratory illness) within 14 days of enrollment
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Days
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Flavin
    Organizational Affiliation
    Queen's University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Treating Wheezing in Children With Hypertonic Saline (TWICS)

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