BronchiolitisBPAPNCT01229384
Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions
A study testing Positive Airway Pressure nebulization and Standard passive nebulization of respiratory medications in people with Bronchiolitis, run by Phoenix Children's Hospital.
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. Read more about this study
- Who is it for?
- Ages 2 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Positive Airway Pressure nebulization and Standard passive nebulization of respiratory medications
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants 2-24 months with moderate to severe bronchiolitis
Who cannot join
- 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
About this study
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.
Read more
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.
- Conditions
- Bronchiolitis
- Being tested
- Positive Airway Pressure nebulization, Standard passive nebulization of respiratory medications
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure nebulizationDevice
Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
Standard passive nebulization of respiratory medicationsDevice
Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Positive Airway Pressure Nebulization | Experimental | Will administer nebulized medications using Positive Airway Pressure Nebulization Receives: Device: Positive Airway Pressure nebulization |
| Standard Nebulization | Active comparator | Current standard of administering nebulized medications without positive airway pressure Receives: Device: Standard passive nebulization of respiratory medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization Rates
Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
Measured: 2 weeks
Secondary outcomes (5)
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.
Measured: day of presentation
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.
Measured: Day of presentation
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.
Measured: day of presentation
Length of Stay
Will measure length of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
Measured: To be determined
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: no enrollments, Trial administratively closed and withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Hostetler, Phoenix Children's Hospital
- Investigators
- Zebulon J Timmons, MD, Principal investigator, Phoenix Children's HospitalMark Hostetler, MD, Study director, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229384
- Sponsor's protocol ID
- BronchPAP
- Acronym
- BPAP
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2010
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions
- ClinicalTrials.gov ID
- NCT01229384
- Acronym / sponsor ID
- BPAP / BronchPAP
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no enrollments, Trial administratively closed and withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Airway Pressure Nebulization | Experimental | Device: Positive Airway Pressure nebulizationWill administer nebulized medications using Positive Airway Pressure Nebulization |
| Standard Nebulization | Active comparator | Device: Standard passive nebulization of respiratory medicationsCurrent standard of administering nebulized medications without positive airway pressure |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants 2-24 months with moderate to severe bronchiolitis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Airway Pressure nebulizationUsing a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure | Device | Positive Airway Pressure Nebulization |
| Standard passive nebulization of respiratory medicationsPatients will receive standard passively inhaled nebulized albuterol and racemic epinephrine. | Device | Standard Nebulization |
Primary outcome
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.
5 secondary outcomes
Change in bronchiolitis Score
Time frame: day of presentation
Change in Oxygen Saturation
Time frame: Day of presentation
Intensive Care Unit Admission Rate
Time frame: day of presentation
Length of Stay
Time frame: To be determined
Unscheduled Return to the Emergency Department
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zebulon J Timmons, MD principal investigator
Phoenix Children's Hospital
Mark Hostetler, MD study director
Phoenix Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Positive Airway Pressure nebulization and Standard passive nebulization of respiratory medications in people with Bronchiolitis, run by Phoenix Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization Rates (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.