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

Phoenix Children's Hospital

Status: Withdrawn

Conditions: Bronchiolitis

Treatments: Device: Standard passive nebulization of respiratory medications; Device: Positive Airway Pressure nebulization

Study type: Interventional

Funder types: Other

Identifiers

NCT01229384

BronchPAP

Details and patient eligibility

About

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.

Sex: All

Ages: 2 to 24 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Positive Airway Pressure Nebulization

Experimental group

Description:

Will administer nebulized medications using Positive Airway Pressure Nebulization

Treatment:

Device: Positive Airway Pressure nebulization

Standard Nebulization

Active Comparator group

Description:

Current standard of administering nebulized medications without positive airway pressure

Treatment:

Device: Standard passive nebulization of respiratory medications