Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis

Study Overview
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Brief Summary
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The purpose of this study is planned to investigate whether frequently inhaled hypertonic saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.

Detailed Description
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The treatment of bronchiolitis remains largely supportive with mechanical ventilatory support as needed .Other types of treatment remain controversial.We and other researchers have demonstrated that nebulized HS and bronchodilators decreased symptoms and LOS for infants with mild to moderate viral bronchiolitis .All the aforementioned studies used 3 times per day dosing, which is significantly less than the 3 to 6 times per hour regimens often used in children in respiratory distress.Frequently nebulized HS reduced the LOS for infants with moderately severe bronchiolitis.The present study is planned to investigate whether frequently inhaled HS can relieve symptoms and signs faster than NS and shorten LOS significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects. PMID: 15266547 PMID: 12576370 PMID: 16599051 PMID: 17719935 PMID: 20014350 PMID: 12475841

Official Title
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A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: 3% hypertonic saline
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants less than 24 months of age with first episode of wheezing. Exclusion Criteria: age>24 months, previous episode of wheezing, chronic cardiac and pulmonary disease, immunodeficiency, accompanying respiratory failure, requiring mechanical ventilation, inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment, premature infants born at less than 34 weeks gestation.

Ages Eligible for Study
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Minimum Age: 1 Month
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: hypertonic saline<br>hypertonic saline (HS) | Drug: 3% hypertonic saline<br>* Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline<br>* Other names: normal saline;|
| Placebo Comparator: normal saline (NS)<br>normal saline (NS) | Drug: normal saline<br>* Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline<br>* Other names: 3% hypertonic saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis | Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis | evaluated for the hoarse voice, vomiting, diarrhea, general condition | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertonic saline solution, bronchiolitis, RSV