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

Bronchiolitis Clinical Trial

— BPAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01229384
• Other study ID #: BronchPAP
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2010
• Last updated: June 8, 2012
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2012
• Source: Phoenix Children's Hospital
• Contact: Zebulon J Timmons, MD
• Phone: 402-203-9303
• Email: ztimmons[@]phoenixchildrens.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 24 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Device:
• Positive Airway Pressure nebulization
Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
• Standard passive nebulization of respiratory medications
Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization Rates	Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.	2 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No