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

Not Applicable

• Conditions: Bronchiolitis
• Interventions: Device: Positive Airway Pressure nebulization; Device: Standard passive nebulization of respiratory medications

• Registration Number: NCT01229384
• Lead Sponsor: Phoenix Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Study Start: 2011-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-08
• Last Update Posted: 2012-06-11
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positive Airway Pressure Nebulization	Positive Airway Pressure nebulization	Will administer nebulized medications using Positive Airway Pressure Nebulization
Standard Nebulization	Standard passive nebulization of respiratory medications	Current standard of administering nebulized medications without positive airway pressure

Primary Outcome Measures

Name	Time	Method
Hospitalization Rates	2 weeks	Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

Secondary Outcome Measures

Name	Time	Method
Change in bronchiolitis Score	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	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	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	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	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.

Trial Locations

Locations (1)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States