Nebulized Hypertonic Saline for Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nebulized 3% saline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring bronchiolitis, hypertonic saline
Eligibility 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
Sites / Locations
- Childrens Hospital Los Angeles
- Children's Hospital & Research Center at Oakland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
3% saline
Normal saline
Outcomes
Primary Outcome Measures
Admission Rate
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
Length of stay defined as date of discharge minute date of admission.
Change in RDAI Score
Secondary Outcome Measures
Hours of Oxygen Use
IV Fluid Use
Supplemental Medication Use
Full Information
NCT ID
NCT00619918
First Posted
February 8, 2008
Last Updated
July 29, 2013
Sponsor
Children's Hospital Los Angeles
Collaborators
UCSF Benioff Children's Hospital Oakland, Thrasher Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT00619918
Brief Title
Nebulized Hypertonic Saline for Bronchiolitis
Official Title
Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
UCSF Benioff Children's Hospital Oakland, Thrasher Research Fund
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, hypertonic saline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
447 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
3% saline
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
Nebulized 3% saline
Other Intervention Name(s)
3% saline
Intervention Description
4 ml inhaled q8h
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
normal saline
Primary Outcome Measure Information:
Title
Admission Rate
Description
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.
Time Frame
1 day
Title
Length of Stay
Description
Length of stay defined as date of discharge minute date of admission.
Time Frame
1 month
Title
Change in RDAI Score
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Hours of Oxygen Use
Time Frame
14 days
Title
IV Fluid Use
Time Frame
14 days
Title
Supplemental Medication Use
Time Frame
14 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Wu, MD
Organizational Affiliation
Childrens Hospital Los Angeles/University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital & Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24862623
Citation
Wu S, Baker C, Lang ME, Schrager SM, Liley FF, Papa C, Mira V, Balkian A, Mason WH. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial. JAMA Pediatr. 2014 Jul;168(7):657-63. doi: 10.1001/jamapediatrics.2014.301. Erratum In: JAMA Pediatr. 2014 Oct;168(10):971.
Results Reference
derived
Learn more about this trial
Nebulized Hypertonic Saline for Bronchiolitis
We'll reach out to this number within 24 hrs