A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Study Overview
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Brief Summary
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The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).

Detailed Description
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Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. There have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. Several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the United States and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the United States. The objective of this study is to conduct the first double-blind, randomized controlled trial in the United States of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.

Official Title
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A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: 3% sodium chloride
* Drug: 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis. Exclusion Criteria: status asthmaticus chronic cardiopulmonary disease Trisomy 21 immunodeficiency or transplant recipient neuromuscular disease admission directly to the intensive care unit previous use of nebulized hypertonic saline less than 12 hours prior to presentation previous enrollment in the study in the 72 hours prior to presentation

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Nebulized Hypertonic Saline<br>4mL nebulized 3% sodium chloride every 4 hours until discharge | Drug: 3% sodium chloride<br>* 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge<br>* Other names: HS;|
| Placebo Comparator: Nebulized Normal Saline<br>4 mL nebulized 0.9% sodium chloride every 4 hours until discharge | Drug: 0.9% sodium chloride<br>* 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in the Study-LOS--Intention to Treat Analysis | Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used. | Time of first study treatment until time of discharge | 
| Length of Stay in the Study-LOS by Per Protocol Analysis | Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used. | Time of first study treatment until time of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission for Bronchiolitis Within 7 Days of Discharge | Phone call at 7 days to assess for readmission to any hospital | within 7 days of hospital discharge | 
| Clinical Worsening | transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment | though hospitalization/time period receiving study treatment, average 2-3 days | 
| Total Adverse Events | Clinical worsening events (defined prior) + 7 day readmissions | Time of enrollment in the study through 1 week after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants, Hypertonic saline, Bronchiolitis, Wheezing, Nebulized, Bronchodilator