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

N/A
Waitlist Available
Led By Zebulon J Timmons, MD
Research Sponsored by Phoenix Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Infants 2-24 months with moderate to severe bronchiolitis
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of presentation
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Bronchiolitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hospitalization Rates
Secondary study objectives
Change in Oxygen Saturation
Change in bronchiolitis Score
Intensive Care Unit Admission Rate
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Positive Airway Pressure NebulizationExperimental Treatment1 Intervention
Will administer nebulized medications using Positive Airway Pressure Nebulization
Group II: Standard NebulizationActive Control1 Intervention
Current standard of administering nebulized medications without positive airway pressure

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor
76 Previous Clinical Trials
5,013,592 Total Patients Enrolled
Zebulon J Timmons, MDPrincipal InvestigatorPhoenix Children's Hospital
Mark Hostetler, MDStudy DirectorPhoenix Children's Hospital
1 Previous Clinical Trials
102 Total Patients Enrolled
~14 spots leftby Dec 2025