- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619918
Nebulized Hypertonic Saline for Bronchiolitis
Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90027
- Childrens Hospital Los Angeles
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Oakland, California, United States, 94609
- Children'S Hospital & Research Center At Oakland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
3% saline
|
4 ml inhaled q8h
Other Names:
|
Placebo Comparator: 2
Normal saline
|
normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Length of Stay
Time Frame: 1 month
|
Length of stay defined as date of discharge minute date of admission.
|
1 month
|
Change in RDAI Score
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hours of Oxygen Use
Time Frame: 14 days
|
14 days
|
IV Fluid Use
Time Frame: 14 days
|
14 days
|
Supplemental Medication Use
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan Wu, MD, Childrens Hospital Los Angeles/University of Southern California
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCI-06-00271
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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