Nebulized Hypertonic Saline for Bronchiolitis
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|ClinicalTrials.gov Identifier: NCT00619918|
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : October 10, 2013
Last Update Posted : October 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Drug: Nebulized 3% saline Drug: Placebo||Phase 2 Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||447 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Drug: Nebulized 3% saline
4 ml inhaled q8h
Other Name: 3% saline
Placebo Comparator: 2
- 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 ]
- Hours of Oxygen Use [ Time Frame: 14 days ]
- IV Fluid Use [ Time Frame: 14 days ]
- Supplemental Medication Use [ Time Frame: 14 days ]
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
|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|
|Principal Investigator:||Susan Wu, MD||Childrens Hospital Los Angeles/University of Southern California|