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

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.

Study Overview

• Status: Unknown
• Conditions: Bronchiolitis
• Intervention / Treatment: Device: Positive Airway Pressure nebulization; Device: Standard passive nebulization of respiratory medications

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zebulon J Timmons, MD; Phone Number: 402-203-9303; Email: ztimmons@phoenixchildrens.com
• Study Contact Backup: Name: Mark Hostetler, MD; Phone Number: 602-546-1910; Email: mhostetler@phoenixchildrens.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children's Hospital
      • Contact: Lara Hale, BA; Phone Number: 602-546-1910; Email: lhale@phoenixchildrens.com
      • Contact: David Bank, MD; Phone Number: 602-546-1910; Email: dbank@phoenixchildrens.com
      • Principal Investigator: Zebulon J Timmons, BA, MD
      • Sub-Investigator: Mark Hostetler, MD
      • Sub-Investigator: David Bank, MD
      • Sub-Investigator: Dawn Barcellona, MD
      • Sub-Investigator: Blake Bulloch, MD
      • Sub-Investigator: Tom McConahay, MD
      • Sub-Investigator: Rustin Morse, MD
      • Sub-Investigator: Theresa Murdock, MD
      • Sub-Investigator: Anthony Pickett, MD
      • Sub-Investigator: Tamara Pottker, MD
      • Sub-Investigator: Chris Ramsook, MD
      • Sub-Investigator: Lalitha Ravi, MD
      • Sub-Investigator: Karen Scharlatt, DO
      • Sub-Investigator: Kopal Seth, MD
      • Sub-Investigator: Robert Yniguez, MD
      • Sub-Investigator: Stephanie Zimmerman, MD
      • Sub-Investigator: Ming Chien, MD
      • Sub-Investigator: Angelique Ferayorni, DO
      • Sub-Investigator: Amanda Kasem, MD
      • Sub-Investigator: William Schneider, DO
      • Sub-Investigator: Karem Collindres-Duque, DO
      • Sub-Investigator: Amanda Queen, PA
      • Sub-Investigator: Lisa Keller, NP
      • Sub-Investigator: Jessica Snow, NP
      • Sub-Investigator: Carol Thrall, NP
      • Sub-Investigator: Becky Brown, NP
      • Sub-Investigator: Scharon Schaeffer, NP
      • Sub-Investigator: Candy Schmitz, NP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Airway Pressure Nebulization; Will administer nebulized medications using Positive Airway Pressure Nebulization	Device: Positive Airway Pressure nebulization; Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
Active Comparator: Standard Nebulization; Current standard of administering nebulized medications without positive airway pressure	Device: Standard passive nebulization of respiratory medications; Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bronchiolitis Score	Will measure change in bronchiolitis score by repiratory therapy of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.	day of presentation
Change in Oxygen Saturation	Will measure change in oxygen saturation of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.	Day of presentation
Intensive Care Unit Admission Rate	Will measure rate of hospitalization in the intensive care unit of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.	day of presentation
Length of Stay	Will measure length of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.	To be determined
Unscheduled Return to the Emergency Department	Will measure rate of unscheduled return to the ED of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.	2 weeks

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital
• Investigators: Principal Investigator: Zebulon J Timmons, MD, Phoenix Children's Hospital; Study Director: Mark Hostetler, MD, Phoenix Children's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: October 26, 2010
• First Submitted That Met QC Criteria: October 26, 2010
• First Posted (Estimate): October 27, 2010

Study Record Updates

• Last Update Posted (Estimate): June 11, 2012
• Last Update Submitted That Met QC Criteria: June 8, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: BronchPAP