WithdrawnNot Applicable

BPAP in Pediatric Asthma Pilot Study

Stopped: PI left institution.

0Started 2021-01-15

Plain-language summary

The investigators aim to study the effect and safety of bilevel positive airway pressure (BPAP) in children with moderate to severe asthma exacerbations - by examining the effects of early initiation of BPAP in pediatric patients who present to the emergency room with a moderate to severe asthma exacerbation. The study is interested in how early initiation of BPAP affects PRAM scores, vital signs, as well as the total duration of continuous albuterol in the patient population.

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Contra-indication to BPAP (facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Scale (GCS) 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy, current weight \< 20kg)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year.

Timeframe: One year

Trial details

NCT IDNCT04656587

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-27

View on ClinicalTrials.gov More Asthma in Children trials