Nasal Irrigation in Infants With Bronchiolitis.

Study Overview
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Brief Summary
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Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration. Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out. The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.

Official Title
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Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: Isotonic solution (NaCl 0.9%)
* Drug: Hypertonic solution (NaCl 3%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants <1 year diagnosis of bronchiolitis with respiratory distress, rhinitis, cough oxygen saturation between 88 and 94% Exclusion Criteria: previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry) chronic illness

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 365 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isotonic solution (NaCl 0.9%)<br>Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril | Drug: Isotonic solution (NaCl 0.9%)<br> <br> |
| Experimental: Hypertonic solution (NaCl 3%)<br>Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril | Drug: Hypertonic solution (NaCl 3%)<br> <br> |
| No Intervention: Supportive care<br>Wiping the nose, positioning the child, changing a wet diaper, feeding. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation (%) | Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter | up to 50 minutes after allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory effort (WARME score) | Evaluation of the respiratory effort using the validated WARME score (evaluation of: 1) respiratory rate; 2) prolonged expiration; 2) wheezing; 3) air exchange; 4) muscle use). | 5, 15, 20, 50 minutes after allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, Normal saline solution, Hypertonic solution, Nasal irrigation