We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Lack of financial support)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02834819
First Posted: July 15, 2016
Last Update Posted: July 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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 Intervention
Bronchiolitis Drug: 3% Nebulized Hypertonic Saline

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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

  • 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.

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

  • 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.

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

  • 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).

  • 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


Enrollment: 29
Study Start Date: September 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02834819     History of Changes
Other Study ID Numbers: 13-0092
First Submitted: April 1, 2016
First Posted: July 15, 2016
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