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

Primary Purpose

Bronchiolitis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Positive Airway Pressure nebulization

Standard passive nebulization of respiratory medications

About this trial

This is an interventional treatment trial for Bronchiolitis

Eligibility Criteria

2 Months - 24 Months (Child)All SexesAccepts 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

Sites / Locations

Phoenix Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive Airway Pressure Nebulization

Standard Nebulization

Arm Description

Will administer nebulized medications using Positive Airway Pressure Nebulization

Current standard of administering nebulized medications without positive airway pressure

Outcomes

Primary Outcome Measures

Hospitalization Rates

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

Secondary Outcome Measures

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.

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.

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.

Length of Stay

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

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.

Full Information

NCT ID

NCT01229384

First Posted

October 26, 2010

Last Updated

June 8, 2012

Sponsor

Phoenix Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01229384

Brief Title

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

Acronym

BPAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Phoenix Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchiolitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Positive Airway Pressure Nebulization

Arm Type

Experimental

Arm Description

Will administer nebulized medications using Positive Airway Pressure Nebulization

Arm Title

Standard Nebulization

Arm Type

Active Comparator

Arm Description

Current standard of administering nebulized medications without positive airway pressure

Intervention Type

Device

Intervention Name(s)

Positive Airway Pressure nebulization

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Standard passive nebulization of respiratory medications

Intervention Description

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

Primary Outcome Measure Information:

Title

Hospitalization Rates

Description

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

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Change in bronchiolitis Score

Description

Will measure change in bronchiolitis score by repiratory therapy of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

Time Frame

day of presentation

Title

Change in Oxygen Saturation

Description

Will measure change in oxygen saturation of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

Time Frame

Day of presentation

Title

Intensive Care Unit Admission Rate

Description

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.

Time Frame

day of presentation

Title

Length of Stay

Description

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

Time Frame

To be determined

Title

Unscheduled Return to the Emergency Department

Description

Will measure rate of unscheduled return to the ED of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zebulon J Timmons, MD

Phone

402-203-9303

ztimmons@phoenixchildrens.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mark Hostetler, MD

Phone

602-546-1910

mhostetler@phoenixchildrens.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zebulon J Timmons, MD

Organizational Affiliation

Phoenix Children's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark Hostetler, MD

Organizational Affiliation

Phoenix Children's Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Phoenix Children's Hospital

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lara Hale, BA

Phone

602-546-1910

lhale@phoenixchildrens.com

First Name & Middle Initial & Last Name & Degree

David Bank, MD

Phone

602-546-1910

dbank@phoenixchildrens.com

First Name & Middle Initial & Last Name & Degree

Zebulon J Timmons, BA, MD

First Name & Middle Initial & Last Name & Degree

Mark Hostetler, MD

First Name & Middle Initial & Last Name & Degree

David Bank, MD

First Name & Middle Initial & Last Name & Degree

Dawn Barcellona, MD

First Name & Middle Initial & Last Name & Degree

Blake Bulloch, MD

First Name & Middle Initial & Last Name & Degree

Tom McConahay, MD

First Name & Middle Initial & Last Name & Degree

Rustin Morse, MD

First Name & Middle Initial & Last Name & Degree

Theresa Murdock, MD

First Name & Middle Initial & Last Name & Degree

Anthony Pickett, MD

First Name & Middle Initial & Last Name & Degree

Tamara Pottker, MD

First Name & Middle Initial & Last Name & Degree

Chris Ramsook, MD

First Name & Middle Initial & Last Name & Degree

Lalitha Ravi, MD

First Name & Middle Initial & Last Name & Degree

Karen Scharlatt, DO

First Name & Middle Initial & Last Name & Degree

Kopal Seth, MD

First Name & Middle Initial & Last Name & Degree

Robert Yniguez, MD

First Name & Middle Initial & Last Name & Degree

Stephanie Zimmerman, MD

First Name & Middle Initial & Last Name & Degree

Ming Chien, MD

First Name & Middle Initial & Last Name & Degree

Angelique Ferayorni, DO

First Name & Middle Initial & Last Name & Degree

Amanda Kasem, MD

First Name & Middle Initial & Last Name & Degree

William Schneider, DO

First Name & Middle Initial & Last Name & Degree

Karem Collindres-Duque, DO

First Name & Middle Initial & Last Name & Degree

Amanda Queen, PA

First Name & Middle Initial & Last Name & Degree

Lisa Keller, NP

First Name & Middle Initial & Last Name & Degree

Jessica Snow, NP

First Name & Middle Initial & Last Name & Degree

Carol Thrall, NP

First Name & Middle Initial & Last Name & Degree

Becky Brown, NP

First Name & Middle Initial & Last Name & Degree

Scharon Schaeffer, NP

First Name & Middle Initial & Last Name & Degree

Candy Schmitz, NP

12. IPD Sharing Statement

Learn more about this trial

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

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