An interventional study of Bilevel positive airway pressure ventilation in Pediatric Asthma, Acute Asthma and BiPAP, sponsored by Columbia University. Recruiting at 3 sites in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to assess the feasibility of early initiation of bilevel positive airway pressure (BPAP) in the emergency department (ED) for children with severe asthma exacerbations. It will also collect preliminary data on the safety and potential effectiveness of this approach.
The main questions it aims to answer are:
Researchers will compare early initiation of BPAP plus standard asthma therapy to standard asthma therapy alone to determine whether early BPAP is a feasible and potentially beneficial treatment strategy.
Participants will 1) receive standard asthma therapy with or without early BPAP in the ED, 2) be monitored closely during the ED visit and hospitalization, and 3) have clinical data collected from routine care, including asthma severity scores, treatments, and outcomes.
The study will enroll approximately 36 participants (about 12 per site) across three sites over one year to inform a future multicenter randomized controlled trial.
Severe asthma exacerbations are a common reason for pediatric emergency department (ED) visits, hospital admissions, and pediatric intensive care unit (PICU) use. Although first-line therapies such as inhaled beta-agonists, anticholinergics, and systemic corticosteroids are well established, the optimal second-line treatment for children who remain in moderate to severe respiratory distress is unclear.
Bilevel positive airway pressure (BPAP) is a form of non-invasive positive pressure ventilation that may improve airway patency, reduce work of breathing, improve ventilation-perfusion matching, and enhance delivery of inhaled bronchodilator therapy. Prior pediatric studies suggest potential physiologic and clinical benefit, but available randomized trials have been small and have generally evaluated BPAP after PICU admission rather than early in the ED course. Therefore, the feasibility, safety, and potential clinical impact of early ED initiation of BPAP remain uncertain.
This multicenter, randomized, unblinded feasibility trial will enroll approximately 36 children across three sites. Participants will be children with severe asthma exacerbations who remain symptomatic after completion of standard first-line therapy and continue to require continuous albuterol. Patients will be randomized to receive either BPAP plus continuous albuterol or continuous albuterol alone during an approximately 2-hour intervention period. BPAP will be delivered using FDA-cleared devices, with mask interface and pressure settings managed according to routine clinical practice. After the intervention period, all further asthma treatment and respiratory support will be determined by the treating clinical team.
The primary purpose of this study is to assess feasibility of conducting a future definitive multicenter randomized trial. Feasibility domains include patient identification, consent and assent processes, timely randomization, BPAP initiation and adherence, completion of asthma severity assessments, and collection of clinical and safety data. Clinical outcomes, including asthma severity, duration of continuous albuterol, BPAP use, ED disposition, PICU and hospital admission, length of stay, and readmission, will be summarized descriptively. Safety monitoring will include adverse events potentially related to BPAP or continuous albuterol, including air leak syndrome, vomiting, aspiration, hypotension, skin breakdown, tachycardia, and tremor.
This feasibility trial is not powered to detect treatment efficacy. Results will be used to refine trial procedures, assess protocol adherence, estimate enrollment and data completion rates, and inform the design of a future multicenter randomized trial evaluating whether early ED initiation of BPAP reduces critical care resource use and improves outcomes in children with severe asthma exacerbations.
Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Absolute or relative contraindication to BPAP, defined as any of the following:
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:
Note: Oxygen is not a required first-line therapy.
Participants randomized to this arm will receive BPAP plus continuous albuterol administered via FDA-approved delivery systems according to routine clinical practice. BPAP will be delivered using an appropriately sized nasal or face mask and managed by trained respiratory therapists and/or nursing staff per standard care. Continuous albuterol will be administered through the BPAP circuit per manufacturer recommendations or site-specific practice. BPAP settings may be adjusted at the discretion of the treating clinician. Participants will remain on BPAP for approximately 2 hours or until continuous albuterol is discontinued, whichever occurs first. After the intervention period, continuation of BPAP will be at the treating clinical team's discretion.
Device: Bilevel positive airway pressure ventilation
Participants randomized to this arm will receive continuous albuterol administered via FDA-approved delivery systems according to routine clinical practice. Non-invasive ventilation (including BPAP or CPAP) will not be initiated during the first approximately 2 hours after randomization unless clinically indicated; if initiated, the reason will be documented. All other aspects of care, including oxygen and adjunctive therapies, will be provided at the discretion of the treating clinical team per standard practice. After the intervention period, escalation of care, including initiation of BPAP or other respiratory support, will be determined by the treating clinician.
This study involves non-invasive positive pressure ventilation (NIPPV) delivered as bilevel positive airway pressure (BPAP) in children aged 5-17 years presenting to the pediatric emergency department with severe asthma exacerbations. BPAP will be administered using FDA-cleared devices according to their intended use and standard clinical practice. Therapy will be delivered via an appropriately fitted nasal or face mask and managed by trained clinical staff. Ventilator settings will be adjusted at the discretion of the treating clinician, and continuous bronchodilator therapy may be delivered through the BPAP circuit per manufacturer recommendations or site practice.
Number of eligible patients who consent
Proportion of approached, eligible patients who provide consent.
Time frame: From screening through randomization, up to 2 hours
Proportion of participants who adhere to the BPAP protocol among all those assigned to the BPAP arm
Proportion of participants in the intervention arm who receive \> 1 hour \& 45 minutes of BPAP during the planned 2-hour intervention period without unplanned interruption (\> 15 consecutive minutes), unless weaned off continuous albuterol.
Time frame: From randomization through end of 2-hour intervention
Potential efficacy outcome: Change in Pediatric Respiratory Assessment Measure (PRAM) score
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the pre-intervention to post-intervention assessment. The PRAM score ranges from 0 to 12, with higher scores indicating greater acute asthma exacerbation severity. Scores are categorized as mild (0-3), moderate (4-7), and severe (8-12).
Time frame: Pre-intervention to end of intervention, approximately 3 hours total
Potential efficacy outcome: Duration of continuous albuterol use
Duration of continuous albuterol therapy
Time frame: From randomization through hospital discharge beyond the intervention period, up to 120 hours.
Potential efficacy outcome: Duration of BPAP use
Duration of BPAP use
Time frame: From randomization through hospital discharge beyond the intervention period, up to 120 hours
Potential efficacy outcome: PICU admission
Proportion of participants requiring admissions to the pediatric intensive care unit during the index ED visit
Time frame: Disposition determined 2 hours after completion of the intervention period
Potential efficacy outcome: Hospital admission
Proportion of participants requiring hospital admission during the index ED visit
Time frame: Disposition determined 2 hours after completion of the intervention period
Potential efficacy outcome: PICU length of stay
Length of stay in the PICU (hours) among participants admitted to the PICU.
Time frame: From PICU admission to PICU discharge, up to 120 hours
Potential efficacy outcome: Hospital length of stay
Total hospital length of stay (hours) among admitted participants.
Time frame: From hospital admission to hospital discharge, up to 120 hours
Safety outcome: Air Leak Syndrome
Proportion of participants with air leak complications (e.g., pneumothorax, pneumomediastinum, pneumopericardium, or subcutaneous emphysema).
Time frame: From randomization until 4 hours post-randomization or until ED discharge, whichever occurs first.
Safety outcome: Vomiting
Proportion of participants experiencing vomiting.
Time frame: From randomization until 4 hours post-randomization or until ED discharge, whichever occurs first.
Safety outcome: Pulmonary aspiration
Proportion of participants with suspected aspiration, defined as emesis followed by new findings on chest radiograph.
Time frame: From randomization until 4 hours post-randomization or until ED discharge, whichever occurs first.
Safety outcome: Systolic hypotension
Proportion of participants with systolic blood pressure below the 5th percentile for age (defined as \<70 mmHg + \[2 × age in years\]).
Time frame: From randomization until 4 hours post-randomization or until ED discharge, whichever occurs first.
Safety outcome: Facial skin breakdown
Proportion of participants with facial pressure injury of Stage 2 or higher per National Pressure Injury Advisory Panel (NPIAP) criteria.
Time frame: From randomization until 4 hours post-randomization or until ED discharge, whichever occurs first.
Plan to share: No
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