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

NCT ID: NCT01229384

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-03-31

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Positive Airway Pressure Nebulization

Will administer nebulized medications using Positive Airway Pressure Nebulization

Group Type: EXPERIMENTAL

Positive Airway Pressure nebulization

Intervention Type: DEVICE

Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure

Standard Nebulization

Current standard of administering nebulized medications without positive airway pressure

Group Type: ACTIVE_COMPARATOR

Standard passive nebulization of respiratory medications

Intervention Type: DEVICE

Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.

Interventions

Positive Airway Pressure nebulization

Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure

Intervention Type: DEVICE

Standard passive nebulization of respiratory medications

Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Phoenix Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark Hostetler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zebulon J Timmons, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Children's Hospital

Mark Hostetler, MD

Role: STUDY_DIRECTOR

Phoenix Children's Hospital

Other Identifiers

BronchPAP

Identifier Type: -

Identifier Source: org_study_id