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Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3% hypertonic saline
normal saline
Sponsored by
Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Hypertonic saline solution, bronchiolitis, RSV

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants less than 24 months of age with first episode of wheezing.

Exclusion Criteria:

  • age>24 months,
  • previous episode of wheezing,
  • chronic cardiac and pulmonary disease,
  • immunodeficiency,
  • accompanying respiratory failure,
  • requiring mechanical ventilation,
  • inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment,
  • premature infants born at less than 34 weeks gestation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    hypertonic saline

    normal saline (NS)

    Arm Description

    hypertonic saline (HS)

    normal saline (NS)

    Outcomes

    Primary Outcome Measures

    To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
    Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.

    Secondary Outcome Measures

    To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
    evaluated for the hoarse voice, vomiting, diarrhea, general condition

    Full Information

    First Posted
    April 23, 2010
    Last Updated
    May 10, 2010
    Sponsor
    Chongqing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01120496
    Brief Title
    Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
    Official Title
    A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chongqing Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is planned to investigate whether frequently inhaled hypertonic saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.
    Detailed Description
    The treatment of bronchiolitis remains largely supportive with mechanical ventilatory support as needed .Other types of treatment remain controversial.We and other researchers have demonstrated that nebulized HS and bronchodilators decreased symptoms and LOS for infants with mild to moderate viral bronchiolitis .All the aforementioned studies used 3 times per day dosing, which is significantly less than the 3 to 6 times per hour regimens often used in children in respiratory distress.Frequently nebulized HS reduced the LOS for infants with moderately severe bronchiolitis.The present study is planned to investigate whether frequently inhaled HS can relieve symptoms and signs faster than NS and shorten LOS significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects. PMID: 15266547 PMID: 12576370 PMID: 16599051 PMID: 17719935 PMID: 20014350 PMID: 12475841

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis
    Keywords
    Hypertonic saline solution, bronchiolitis, RSV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    135 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    hypertonic saline
    Arm Type
    Experimental
    Arm Description
    hypertonic saline (HS)
    Arm Title
    normal saline (NS)
    Arm Type
    Placebo Comparator
    Arm Description
    normal saline (NS)
    Intervention Type
    Drug
    Intervention Name(s)
    3% hypertonic saline
    Other Intervention Name(s)
    normal saline
    Intervention Description
    Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Other Intervention Name(s)
    3% hypertonic saline
    Intervention Description
    Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
    Primary Outcome Measure Information:
    Title
    To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
    Description
    Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
    Description
    evaluated for the hoarse voice, vomiting, diarrhea, general condition
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infants less than 24 months of age with first episode of wheezing. Exclusion Criteria: age>24 months, previous episode of wheezing, chronic cardiac and pulmonary disease, immunodeficiency, accompanying respiratory failure, requiring mechanical ventilation, inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment, premature infants born at less than 34 weeks gestation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    zhengxiu luo, doctor
    Organizational Affiliation
    Chongqing Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.clinicaltrials.gov
    Description
    Related Info

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