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

NCT01229384 | Withdrawn FDA Device

• 1 other identifier: BronchPAP
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Hospitalization Rates

  Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

  2 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Positive Airway Pressure Nebulization

EXPERIMENTAL

Will administer nebulized medications using Positive Airway Pressure Nebulization

Device: Positive Airway Pressure nebulization

Standard Nebulization

ACTIVE COMPARATOR

Current standard of administering nebulized medications without positive airway pressure

Device: Standard passive nebulization of respiratory medications

Interventions

Positive Airway Pressure nebulization DEVICE

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

Positive Airway Pressure Nebulization

Standard passive nebulization of respiratory medications DEVICE

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

Standard Nebulization

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants 2-24 months with moderate to severe bronchiolitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Zebulon J Timmons, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

• Mark Hostetler, MD

  Phoenix Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 23, 2026

Record last verified: 2026-01