Crossover Study of Work of Breathing With Different BiPAP Pressure Settings in Premature Infants

What this Trial Is About

Researchers are investigating how to best support the breathing of premature infants who have breathing difficulties at birth and may need help from a breathing machine. This study focuses on bilevel continuous positive airway pressure (BiPAP), which provides two levels of pressure to aid breathing. The goal is to find the optimal upper pressure setting on BiPAP that reduces the effort babies need to breathe. The study involves preterm infants born before 34 weeks gestation who require respiratory support before intubation, after extubation, or have ongoing breathing needs potentially linked to bronchopulmonary dysplasia. Infants in the study will experience three different upper BiPAP pressure settings—13cmH2O, 10cmH2O, and 7cmH2O—all with a baseline pressure of 5cmH2O. Each pressure level will be applied for 20 minutes, separated by a period of standard pressure for 20 minutes. A thin catheter passed through the mouth into the stomach will measure the baby’s work of breathing, alongside other simultaneous measurements. The infants are grouped based on their respiratory support needs: before intubation, after extubation, and after seven days on support. During the study, researchers will collect breathing effort data and other clinical information. Data will be securely stored and anonymized following privacy regulations. The primary outcome is the work of breathing measured over the last five minutes of each 20-minute BiPAP setting. Safety monitoring includes recording any adverse events. The total participation time varies with each infant’s BiPAP evaluation sessions. The study aims to recruit 21 infants to compare the different pressure settings and identify the most effective support level.

Different Levels of BiPAP