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no enrollments, Trial administratively closed and withdrawn
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Airway Pressure Nebulization | Experimental | Will administer nebulized medications using Positive Airway Pressure Nebulization |
|
| Standard Nebulization | Active Comparator | Current standard of administering nebulized medications without positive airway pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure nebulization | Device | Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zebulon J Timmons, MD | Phoenix Children's Hospital | Principal Investigator |
| Mark Hostetler, MD | Phoenix Children's Hospital | Study Director |
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| Standard passive nebulization of respiratory medications | Device | Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine. |
|
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 |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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