Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions
Overview
- Phase
- Not Applicable
- Intervention
- Positive Airway Pressure nebulization
- Conditions
- Bronchiolitis
- Sponsor
- Phoenix Children's Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Hospitalization Rates
- Status
- Withdrawn
- Last Updated
- 3 months ago
Overview
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.
Investigators
Mark Hostetler
Principal Investigator
Phoenix Children's Hospital
Eligibility Criteria
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
Arms & Interventions
Positive Airway Pressure Nebulization
Will administer nebulized medications using Positive Airway Pressure Nebulization
Intervention: Positive Airway Pressure nebulization
Standard Nebulization
Current standard of administering nebulized medications without positive airway pressure
Intervention: Standard passive nebulization of respiratory medications
Outcomes
Primary Outcomes
Hospitalization Rates
Time Frame: 2 weeks
Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
Secondary Outcomes
- Change in bronchiolitis Score(day of presentation)
- Change in Oxygen Saturation(Day of presentation)
- Intensive Care Unit Admission Rate(day of presentation)
- Length of Stay(To be determined)
- Unscheduled Return to the Emergency Department(2 weeks)