Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions (BPAP)
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|ClinicalTrials.gov Identifier: NCT01229384|
Recruitment Status : Unknown
Verified June 2012 by Mark Hostetler, Phoenix Children's Hospital.
Recruitment status was: Recruiting
First Posted : October 27, 2010
Last Update Posted : June 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Device: Positive Airway Pressure nebulization Device: Standard passive nebulization of respiratory medications||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2013|
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.
- Hospitalization Rates [ Time Frame: 2 weeks ]Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
- Change in bronchiolitis Score [ Time Frame: day of presentation ]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 [ Time Frame: Day of presentation ]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 [ Time Frame: day of presentation ]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 [ Time Frame: To be determined ]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 [ Time Frame: 2 weeks ]Will measure rate of unscheduled return to the ED of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229384
|Contact: Zebulon J Timmons, MDfirstname.lastname@example.org|
|Contact: Mark Hostetler, MDemail@example.com|
|United States, Arizona|
|Phoenix Children's Hospital||Recruiting|
|Phoenix, Arizona, United States, 85016|
|Contact: Lara Hale, BA 602-546-1910 firstname.lastname@example.org|
|Contact: David Bank, MD 602-546-1910 email@example.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|
|Principal Investigator:||Zebulon J Timmons, MD||Phoenix Children's Hospital|
|Study Director:||Mark Hostetler, MD||Phoenix Children's Hospital|