Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions

Study Overview
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Brief Summary
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Hypothesis: That administration of nebulized therapy for bronchiolitis when using positive airway pressure is superior to standard mask ventilation in reducing hospital admissions. Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by a variety of different viruses. It is the most common LRTI in children under 24 months old. Multiple studies have documented variation in treatment, hospitalization rates, and length of hospital stay for bronchiolitis, suggesting a lack of consensus and an opportunity to improve care for this common disorder. Research to determine optimal delivery methods of respiratory medications that may augment oxygenation by decreasing atelectasis (Lung cell collapse) and increasing oxygen saturation have not been done. Currently bronchodilators are delivered through a passive process, inhaled as they are nebulized (made from liquid into gas) into a face mask. This study will evaluate whether using a newly developed positive pressure nebulization device that uses pressure to expand lung cells and, hypothetically, deliver the medication better, improves oxygenation by reducing atelectasis (lung cell collapse) to decrease hospitalization in infants with moderate to severe bronchiolitis. Positive pressure nebulization is a relatively new adaptation of a previously existing modality, and is already currently in use here at PCH.

Official Title
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Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions

Conditions
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Bronchiolitis

Intervention / Treatment
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* Device: Positive Airway Pressure nebulization
* Device: Standard passive nebulization of respiratory medications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants 2-24 months with moderate to severe bronchiolitis Exclusion Criteria: Those outside the age range of 2-24 months, or less than postconceptual age of 48weeks for premature infants Those with comorbid conditions such as cyanotic heart disease, home oxygen use, tracheostomy use, or other serious medical conditions. Those with history of apnea

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 24 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Airway Pressure Nebulization<br>Will administer nebulized medications using Positive Airway Pressure Nebulization | Device: Positive Airway Pressure nebulization<br>* Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure<br>|
| Active Comparator: Standard Nebulization<br>Current standard of administering nebulized medications without positive airway pressure | Device: Standard passive nebulization of respiratory medications<br>* Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization Rates | Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bronchiolitis Score | Will measure change in bronchiolitis score by repiratory therapy of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. | day of presentation | 
| Change in Oxygen Saturation | Will measure change in oxygen saturation of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. | Day of presentation | 
| Intensive Care Unit Admission Rate | Will measure rate of hospitalization in the intensive care unit of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. | day of presentation | 
| Length of Stay | Will measure length of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. | To be determined | 
| Unscheduled Return to the Emergency Department | Will measure rate of unscheduled return to the ED of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. | 2 weeks |