Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

Study Overview
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Brief Summary
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Background: Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Despite the high prevalence and morbidity of bronchiolitis, therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation remains the cornerstone of therapy for these infants. Over the past 2 decades, research on bronchiolitis management has explored the use of nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary clearance, as well as reduce airway edema. Aim:The aim of this study is to investigate whether the addition of frequently nebulized hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill infants hospitalized with bronchiolitis.

Detailed Description
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The investigators will conduct this prospective double blind randomized clinical trial by comparing between 2 groups of patients with bronchiolitis, first group will receive 3% hypertonic saline and second group will receive 0.9% saline. Data collection includes: Name, Age, Mode of delivery, Birth weight, Current weight, Number of sibling, Immunization record, Duration of breast feeding, past medical history including number of wheezy chest, pneumonia, Parents level of education, Presence of Asthma / Allergic rhinitis in family, Pets /Smoke at home) Using the validated Respiratory Distress Assessment Instrument (RDAI) investigators will assign patients a score before and at the end of treatment. To prepare 3% sodium chloride, the investigators will dilute 60 ml 20% sodium chloride injection with 500 ml normal saline (NSS) 0.9%. Length of stay will be measured in both groups, to establish the efficacy of hypertonic saline in reducing length of stay.

Official Title
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Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis

Conditions
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Length of Hospital Stay

Intervention / Treatment
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* Other: Normal saline
* Other: Hypertonic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants up to 24 months of age with diagnosis of acute bronchiolitis In accordance with 2006 American Academy of Pediatrics (AAP) definition of bronchiolitis,we did not limit to the first episode of wheeze Patients with the diagnosis of bronchiolitis Exclusion Criteria: Chronic lung or heart disease (hemodynamically significant cardiac disease, chronic lung disease / bronchopulmonary dysplasia requiring diuretics or oxygen) Cystic fibrosis, trisomy 21, immunodeficiency / transplant recipient, neuromuscular disease

Ages Eligible for Study
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Minimum Age: 15 Days
Maximum Age: 2 Years

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: Normal saline<br>Sodium Chloride 0.9% will be provided | Other: Normal saline<br>* The normal saline will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.<br>|
| Experimental: Hypertonic saline<br>500 ml Sodium Chloride 0.9% with 60 ml Sodium Chloride 20% will be provided | Other: Hypertonic saline<br>* The mixture (500 ml Sodium Chloride 0.9% with 60 ml Sodium chloride 20%) will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | from date of admission to discharge date | an average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfer to pediatric intensive care unit (PICU) | admission to PICU | an average of 3 days | 
| use of mechanical ventilator | clinical worsening of patients requiring mechanical ventilator | an average of 3 days |