Could a breathing machine help kids with severe asthma avoid the ICU?
NCT ID NCT07582211
First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 5 times
Summary
This study tests whether giving children aged 5-17 with severe asthma attacks early breathing support (called BPAP) in the emergency room is practical and safe. About 36 children will either get standard asthma care alone or standard care plus BPAP. The goal is to see if this approach can be studied in a larger trial and whether it might improve breathing and reduce the need for intensive care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bilevel positive airway pressure (BPAP) device
- What this could lead to
- If this works, it could show that early BPAP breathing support helps children with severe asthma attacks recover faster and avoid intensive care.
- What could go wrong
- This is a very small, early feasibility study with only 36 children. It is not designed to prove effectiveness, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation. 2. Demonstrate moderate-severe asthma exacerbation at triage (i.e., receive an institutional asthma score equivalent to moderate-severe asthma exacerbation or a Pediatric Respiratory Assessment Measure (PRAM) score of 6 or above). Exclusion Criteria: 1. Prior participation in the study. 2. Use of BPAP at any time within approximately 12 hours for this acute asthma exacerbation, including in prehospital, ED, or inpatient settings, prior to randomization. 3. Receipt of continuous albuterol for over 150 minutes prior to being approached for consent. 4. If a blood gas is obtained, PaCO2 greater than 60 mmHg on the most recent blood gas prior to being approached for consent. Note: Blood gas values are not required for eligibility confirmation. 5. Anticipated immediate need (i.e., within approximately an hour after completion of first-line therapy) for invasive mechanical ventilation (e.g., endotracheal tube or laryngeal mask airway) or non-invasive mechanical ventilation (e.g., continuous positive airway pressure (CPAP) or BPAP), as determined by the treating physician. 6. Presence of a tracheostomy or a baseline requirement for noninvasive ventilation. 7. Wheezing due to non-asthma causes (e.g., foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, or anaphylaxis). 8. Absolute or relative contraindication to BPAP, defined as any of the following: 1. Facial trauma within the area where the face mask would be applied for BPAP (excluding minor abrasion or cuts on forehead or skull). 2. Uncontrollable vomiting (i.e., \> 3 episodes within approximately 1 hour prior to being approached for consent). 3. Hypotension for age, defined as systolic blood pressure (SBP) less than 70 plus twice the patient's age in years (i.e., SBP \< 70 + \[2 x age in years\]). 4. Glasgow Coma Score of 8 or less. 5. Known or clinical suspicion for air leak syndrome (e.g., pneumothorax, pneumomediastinum, pneumopericardium, or subcutaneous emphysema). 9. Weight \< 20 kg. 10. Presence of an intra-abdominal mass compressing the stomach (e.g., due to tumor or large volume ascites) through EMR or medical history. 11. Known or suspected pregnancy by history or if pregnancy test completed by clinical team. 12. Any medical condition that, in the opinion of a site investigator, could 1) lead to difficulty complying with protocol procedures, 2) interfere with the safe completion of the study, or 3) affect the validity of the endpoint assessments. 13. PRAM score less than 7 or greater than 10 based on concurrent clinical assessment by a healthcare provider after completion of standard first-line therapies, which is defined as receiving all of the following prior to ED arrival or during the ED encounter for this acute asthma exacerbation: 1. Albuterol with or without ipratropium bromide, either at least 3 albuterol doses via inhalation method (e.g., metered-dose inhaler (MDI) or nebulized) or at least one hour of continuous albuterol (i.e., continuous nebulized albuterol or three consecutive intermittent nebulized albuterol treatments as bridging therapy). 2. Corticosteroids (e.g., Prednisolone, Prednisone, Dexamethasone/Decadron, or Methylprednisolone) via enteral, intravenous, or intramuscular methods. Note: Oxygen is not a required first-line therapy. 14. Do not require continuous albuterol or a second round of albuterol treatments (e.g., three back-to-back treatments or one hour of burst albuterol treatment) following completion of standard first-line therapies.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital of Philadelphia
NOT_YET_RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
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Nationwide Children's Hospital
NOT_YET_RECRUITINGColumbus, Ohio, 43205, United States
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