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

NCT02834819 | Terminated Results

• 1 other identifier: 13-0092
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; hypoxia; hypertonic saline

Outcome Measures

Primary Outcomes (3)

• Hospitalization Rate

  Effect of nebulized 3% hypertonic saline on hospitalization rate in children with bronchiolitis compared to those who receive the current standard of care

  At any point during enrollment visit or up to 7 days after enrollment visit.

• Number of Patients With Persistent Hypoxia

  To assess the effect of nebulized hypertonic saline on hypoxia in children with bronchiolitis compared to those who receive current standard of care.

  At baseline and 90 minutes post-intervention

• Need for Supplemental Oxygen After Discharge

  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.

  At time of discharge from the hospital through 7 days.

Secondary Outcomes (5)

• Pre- Intervention Clinical Severity Score

  During Enrollment visit following randomization.

• Post-intervention Clinical Severity Score

  During enrollment visit - 90 minutes after randomization

• Unscheduled Return ED Visits

  Called at 7 days post enrollment visit to assess any visit within 3 days of enrollment visit

• Adverse Outcomes

  During enrollment visit or within 7 days following enrollment visit

• Hospital Admission After Discharge

  Within 7 days following discharge from enrollment visit

Study Arms (2)

Hypertonic Saline

EXPERIMENTAL

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 treatment

NO INTERVENTION

Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.

Interventions

3% Nebulized Hypertonic Saline DRUG

Hypertonic Saline

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Related Publications (10)

• Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.

  PMID: 20100768 BACKGROUND

• American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.

  PMID: 17015575 BACKGROUND

• Yorita KL, Holman RC, Sejvar JJ, Steiner CA, Schonberger LB. Infectious disease hospitalizations among infants in the United States. Pediatrics. 2008 Feb;121(2):244-52. doi: 10.1542/peds.2007-1392.

  PMID: 18245414 BACKGROUND

• Kini NM, Robbins JM, Kirschbaum MS, Frisbee SJ, Kotagal UR; Child Health Accountability Initiative. Inpatient care for uncomplicated bronchiolitis: comparison with Milliman and Robertson guidelines. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1323-7. doi: 10.1001/archpedi.155.12.1323.

  PMID: 11732950 BACKGROUND

• Pelletier AJ, Mansbach JM, Camargo CA Jr. Direct medical costs of bronchiolitis hospitalizations in the United States. Pediatrics. 2006 Dec;118(6):2418-23. doi: 10.1542/peds.2006-1193.

  PMID: 17142527 BACKGROUND

• Mallory MD, Shay DK, Garrett J, Bordley WC. Bronchiolitis management preferences and the influence of pulse oximetry and respiratory rate on the decision to admit. Pediatrics. 2003 Jan;111(1):e45-51. doi: 10.1542/peds.111.1.e45.

  PMID: 12509594 BACKGROUND

• Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.

  PMID: 18843717 BACKGROUND

• Mai XM, Nilsson L, Kjellman NI, Bjorksten B. Hypertonic saline challenge tests in the diagnosis of bronchial hyperresponsiveness and asthma in children. Pediatr Allergy Immunol. 2002 Oct;13(5):361-7. doi: 10.1034/j.1399-3038.2002.01011.x.

  PMID: 12431196 BACKGROUND

• Wark P, McDonald VM. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD001506. doi: 10.1002/14651858.CD001506.pub3.

  PMID: 19370568 BACKGROUND

• Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.

  PMID: 20713480 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis; Hypoxia

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cortney Braund, MD
• Organization: Children's Hospital Colorado/University of Colorado

Cortney.Braund@childrenscolorado.org

4406696880

Study Officials

• Cortney Braund, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: July 15, 2016
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-02