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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Phoenix Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mark Hostetler, Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT01229384
First received: October 26, 2010
Last updated: June 8, 2012
Last verified: June 2012

October 26, 2010
June 8, 2012
October 2011
March 2013   (final data collection date for primary outcome measure)
Hospitalization Rates [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
Same as current
Complete list of historical versions of study NCT01229384 on ClinicalTrials.gov Archive Site
  • Change in bronchiolitis Score [ Time Frame: day of presentation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will measure rate of unscheduled return to the ED of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions
Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Bronchiolitis
  • Device: Positive Airway Pressure nebulization
    Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
  • Device: Standard passive nebulization of respiratory medications
    Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.
  • Experimental: Positive Airway Pressure Nebulization
    Will administer nebulized medications using Positive Airway Pressure Nebulization
    Intervention: Device: Positive Airway Pressure nebulization
  • Active Comparator: Standard Nebulization
    Current standard of administering nebulized medications without positive airway pressure
    Intervention: Device: Standard passive nebulization of respiratory medications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
2 Months to 24 Months
Yes
Contact: Zebulon J Timmons, MD 402-203-9303 ztimmons@phoenixchildrens.com
Contact: Mark Hostetler, MD 602-546-1910 mhostetler@phoenixchildrens.com
United States
 
NCT01229384
BronchPAP
Yes
Mark Hostetler, Phoenix Children's Hospital
Phoenix Children's Hospital
Not Provided
Principal Investigator: Zebulon J Timmons, MD Phoenix Children's Hospital
Study Director: Mark Hostetler, MD Phoenix Children's Hospital
Phoenix Children's Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP