Nebulized Hypertonic Saline for Bronchiolitis

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital & Research Center Oakland
Thrasher Research Fund
Information provided by (Responsible Party):
Susan Wu, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT00619918
First received: February 8, 2008
Last updated: July 29, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis

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

Primary Outcome Measures:
  • Admission Rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Length of stay defined as date of discharge minute date of admission.

  • Change in RDAI Score [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hours of Oxygen Use [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • IV Fluid Use [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Supplemental Medication Use [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Children's Hospital Los Angeles

Additional 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
Study First Received: February 8, 2008
Results First Received: July 29, 2013
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014