Bronchiolitis
Conditions
Brief summary
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.
Interventions
DEVICEPositive Airway Pressure nebulization
Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
DEVICEStandard passive nebulization of respiratory medications
Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.
Sponsors
Phoenix Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization Rates | 2 weeks | Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in bronchiolitis Score | day of presentation | Will measure change in bronchiolitis score by repiratory therapy of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. |
| Change in Oxygen Saturation | Day of presentation | Will measure change in oxygen saturation of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. |
| Intensive Care Unit Admission Rate | day of presentation | 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. |
| Length of Stay | To be determined | Will measure length of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. |
| Unscheduled Return to the Emergency Department | 2 weeks | Will measure rate of unscheduled return to the ED of children comparing those treated with positive airway pressure nebulization and those with standard nebulization. |
Contacts
PRINCIPAL_INVESTIGATORZebulon J Timmons, MD
Phoenix Children's Hospital
STUDY_DIRECTORMark Hostetler, MD
Phoenix Children's Hospital
Outcome results
None listed