Bilevel positive airway pressure (BPAP) for severe pediatric asthma exacerbations: A randomized, controlled trial.

/ABSTRACT Severe asthma exacerbations are a major cause of intensive care unit admissions in children, leading to significant healthcare burden in the United States. While there are clear guidelines for first-line treatment, the benefit of non-invasive ventilation (NIV) remains unknown for children who fail to respond to the first-line treatment. Bilevel Positive Airway Pressure (BPAP) is a type of NIV that may be an important second-line therapy for managing severe asthma exacerbations in children but has not been sufficiently studied. Our ultimate goal is to determine if early, emergency department (ED) initiation of BPAP for at least two hours decreases critical care resource use and is safe in children with severe asthma exacerbations. As a step toward this goal, the aims of the proposed study are: Specific Aim 1: To develop a consensus-derived protocol for ED BPAP administration and the use of asthma therapies for children with severe asthma exacerbations among sites that may participate in the definitive trial and among whom practice variation exists. We will use a consensus decision-making model to create a protocol for ED BPAP use and other asthma therapies. Specific Aim 2: To determine a primary outcome measure for the definitive study of early ED BPAP in children with severe asthma exacerbations that reflects critical care resource use. We will use a Delphi method to gain consensus across sites, with measures to be evaluated including, but not limited to: intensive care unit (ICU) admission rate, ICU length of stay, duration of BPAP use, and duration of continuous albuterol. Specific Aim 3: To demonstrate the feasibility to enroll sufficient patients, adhere to an ED protocol for BPAP use for at least 2 hours, and complete other key study procedures for a subsequent multicenter randomized trial comparing early ED BPAP to no BPAP for children with severe asthma exacerbations. We will conduct a feasibility RCT that aims to mirror a subsequent multicenter trial in design, population, intervention arms, procedures, and outcomes assessed. The study will be conducted within the Pediatric Emergency Care Applied Research Network (PECARN). The results will inform the definitive trial of early use of ED BPAP in children with severe acute asthma. The definitive RCT will potentially have a tremendous benefit to both individual patients and the healthcare system. Project Number: 1R34HL173384-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Maria Kwok (+1 co-PI) | Institution: COLUMBIA UNIVERSITY HEALTH SCIENCES, NEW YORK, NY | Award Amount: $427,256 | Activity Code: R34 | Study Section: NHLBI Single-Site and Pilot Clinical Trials Study Section[SSPT (OA)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R34HL17338401A1