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Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis

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ClinicalTrials.gov Identifier: NCT02834819
Recruitment Status : Terminated (Lack of financial support)
First Posted : July 15, 2016
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The purpose of this study is to determine whether nebulized 3% hypertonic saline is more effective than the current standard of care in the treatment of viral bronchiolitis in children.

Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: 3% Nebulized Hypertonic Saline Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
Study Start Date : September 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Hypertonic Saline
Patients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline. They will also receive what is considered standard of care, which includes suctioning and supportive care as needed.
Drug: 3% Nebulized Hypertonic Saline
No Intervention: No treatment
Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.



Primary Outcome Measures :
  1. Hospitalization Rate [ Time Frame: At any point during enrollment visit or up to 7 days after enrollment visit. ]
    Effect of nebulized 3% hypertonic saline on hospitalization rate in children with bronchiolitis compared to those who receive the current standard of care

  2. Persistent Hypoxia [ Time Frame: At baseline and 90 minutes post-intervention ]
    To assess the effect of nebulized hypertonic saline on hypoxia in children with bronchiolitis compared to those who receive current standard of care.

  3. Need for Supplemental Oxygen after discharge [ Time Frame: At time of discharge from the hospital through 7 days. ]
    To assess the effect of nebulized hypertonic saline on supplemental home oxygen requirement in children with bronchiolitis compared to those who receive the current standard of care.


Secondary Outcome Measures :
  1. Pre- Intervention clinical severity score [ Time Frame: During Enrollment visit following randomization. ]
    Clinical severity score taken immediately following randomization, and prior to any intervention.

  2. Post-intervention clinical severity score [ Time Frame: During enrollment visit - 90 minutes after randomization ]
    Clinical severity score taken at time 90 minutes in both arms.

  3. Unscheduled return ED visits [ Time Frame: 7 days post enrollment visit ]
    Unscheduled visit to ED within 3 days of enrollment visit

  4. Adverse outcomes [ Time Frame: During enrollment visit or within 7 days following enrollment visit ]
    Respiratory distress, increased oxygen requirement, advanced airway interventions (NIPPV or intubation).

  5. Hospital Admission after Discharge [ Time Frame: Within 7 days following discharge from enrollment visit ]
    Admission to any hospital institution within 7 days following enrollment visit



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Ages Eligible for Study:   3 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting to Children's Hospital Colorado ED
  • ≥3 to ≤18 months of age
  • Diagnosed with bronchiolitis
  • Have persistent hypoxia following initial supportive care measures as outlined by Children's Hospital Colorado Bronchiolitis Clinical Care Guideline
  • Started on Children's Hospital Colorado Home Oxygen Pathway

Exclusion Criteria:

  • Patients who do not qualify for the Clinical Care Guideline for Home oxygen for Bronchiolitis
  • Previous history of wheezing
  • History of reactive airway disease
  • History of underlying heart disease
  • Require >0.5L oxygen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834819


Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Cortney Braund, MD University of Colorado, Denver

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02834819     History of Changes
Other Study ID Numbers: 13-0092
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Colorado, Denver:
bronchiolitis
hypoxia
hypertonic saline

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections