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Nebulized Hypertonic Saline for Bronchiolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00619918
First Posted: February 21, 2008
Last Update Posted: October 10, 2013
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.
Collaborators:
Children's Hospital & Research Center Oakland
Thrasher Research Fund
Information provided by (Responsible Party):
Susan Wu, Children's Hospital Los Angeles
  Purpose
This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.

Condition Intervention Phase
Bronchiolitis Drug: Nebulized 3% saline Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis

Further study details as provided by Susan Wu, Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Admission Rate [ Time Frame: 1 day ]
    Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.

  • Length of Stay [ Time Frame: 1 month ]
    Length of stay defined as date of discharge minute date of admission.

  • Change in RDAI Score [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Hours of Oxygen Use [ Time Frame: 14 days ]
  • IV Fluid Use [ Time Frame: 14 days ]
  • Supplemental Medication Use [ Time Frame: 14 days ]

Enrollment: 447
Study Start Date: February 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
3% saline
Drug: Nebulized 3% saline
4 ml inhaled q8h
Other Name: 3% saline
Placebo Comparator: 2
Normal saline
Drug: Placebo
normal saline

Detailed Description:

Bronchiolitis is the most common viral respiratory infection in young children and infants. It is responsible for hundreds of thousands of outpatient visits and hospitalizations every year. Hypertonic saline may decrease swelling in the lung tissue, improve the patient's ability to clear secretions, and decrease nasal congestion. Hypertonic saline nebulizations have already been used effectively in patients with cystic fibrosis and in a few small trials on infants with bronchiolitis. Patients who come to the emergency department or inpatient ward of two urban free-standing pediatric hospitals in California between December and April and are diagnosed with bronchiolitis will be randomized into two groups- the control group will receive nebulized 0.9% normal saline, while the study group will receive nebulized 3% hypertonic saline. Nebulizations will be pretreated with albuterol, to prevent the theoretical risk of increased wheezing in patients with undiagnosed underlying asthma. Patients will be given up to 3 nebulizations in the emergency department, after which time the attending physician will decide whether admission to the hospital is required. Patients who are admitted will continue to receive the same nebulized treatment every 8 hours until discharged. Additional interventions such as epinephrine treatments and antibiotics can be ordered as indicated by the patient care team.

Investigators will measure symptom severity before and after treatments using the respiratory distress assessment instrument (RDAI). The investigators will compare rates of being admitted to the hospital in each group. The investigators will also compare RDAI scores, average length of stay, number of additional respiratory treatments needed, number of hours requiring oxygen, amount of IV fluid needed, and frequency of adverse effects. The investigators hypothesize that nebulized hypertonic saline will be a safe, cost-effective, and efficacious therapy which can be utilized in the outpatient setting to prevent hospital admission, as well as decrease length of stay for patients who require admission. Given the significant disease burden of viral bronchiolitis, the potential impact is substantial.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of viral bronchiolitis
  • between November and April

Exclusion Criteria:

  • prematurity < 34 weeks
  • chronic lung disease
  • congenital heart disease
  • history of wheezing, asthma or albuterol use
  • tracheostomy status
  • need for intensive care of assisted ventilation
  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): NCT00619918


Locations
United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital & Research Center at Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital Los Angeles
Children's Hospital & Research Center Oakland
Thrasher Research Fund
Investigators
Principal Investigator: Susan Wu, MD Childrens Hospital Los Angeles/University of Southern California
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Wu, Assistant Professor of Clinical Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT00619918     History of Changes
Other Study ID Numbers: CCI-06-00271
First Submitted: February 8, 2008
First Posted: February 21, 2008
Results First Submitted: July 29, 2013
Results First Posted: October 10, 2013
Last Update Posted: October 10, 2013
Last Verified: July 2013

Keywords provided by Susan Wu, Children's Hospital Los Angeles:
bronchiolitis
hypertonic saline

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