Nebulized Hypertonic Saline for Bronchiolitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: Nebulized 3% saline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3% saline | Drug: Nebulized 3% saline<br>* 4 ml inhaled q8h<br>* Other names: 3% saline;|
| Placebo Comparator: 2<br>Normal saline | Drug: Placebo<br>* normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 
| Length of Stay | Length of stay defined as date of discharge minute date of admission. | 1 month | 
| Change in RDAI Score |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours of Oxygen Use |  | 14 days | 
| IV Fluid Use |  | 14 days | 
| Supplemental Medication Use |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchiolitis, hypertonic saline