NCT01229384

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Phoenix Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Months – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
DEVICE	Positive Airway Pressure nebulization	Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
DEVICE	Standard passive nebulization of respiratory medications	Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-10-27
• Last updated: 2026-01-23

Regulatory

• FDA-regulated device study