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Bilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study

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What is being tested

Philips Respironics V60 Non-invasive ventilator, BPAP

+ Standard Therapy

DeviceOther
Who is being recruted

Asthma+5

+ Bronchial Diseases

+ Hypersensitivity

From 5 to 17 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2021
See protocol details

Summary

Principal SponsorColumbia University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2021

Actual date on which the first participant was enrolled.

Asthma is the most common chronic illness of childhood. Bilevel positive airway pressure (BPAP) has been suggested as an adjunct therapy in the setting of moderate to severe asthma exacerbations. It is a form of noninvasive positive pressure ventilation that provides both an inspiratory positive airway pressure (IPAP) as well as an expiratory positive airway pressure (EPAP). The goal of this study is to determine the feasibility of enrolling, randomizing, and completing data collection in at least 30 participants over a one-year period. The investigators will enroll children 5 to 17 years of age presenting to the emergency department with a moderate to severe asthma exacerbation. Eligible participants will be randomized into two groups: standard therapy (continuous albuterol) or standard therapy plus BPAP. The following data will be collected: Pediatric Respiratory Assessment Measure (PRAM) score at 0, 2 and 4 hours, vital signs at 0, 2 and 4 hours, rate of adverse events and Pediatric Intensive Care Unit (PICU) admissions, duration continuous albuterol, length of hospital stay, and rates of intubations or deaths.

Official TitleBilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study
NCT04656587
Principal SponsorColumbia University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesStatus Asthmaticus

Criteria

4 inclusion criteria required to participate
5 to 17 years of age (inclusive) presenting to the Emergency Department (ED) with an asthma exacerbation

Prior clinician diagnosis of asthma

PRAM score of 4 or greater after initial albuterol/atrovent back to backs, steroids, +/- oxygen

Need for continuous nebulized albuterol therapy

5 exclusion criteria prevent from participating
Hypercapneic respiratory failure (partial pressure of carbon dioxide > 60 mmHg)

Hypoxemic respiratory failure (SaO2 < 90% with fraction of inspired oxygen > 0.35)

Presence of a tracheostomy or baseline noninvasive ventilation requirement

Non-asthma causes of wheezing (foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Application of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.

Group II

Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers