48
Participants
Start Date
October 1, 2025
Primary Completion Date
October 30, 2026
Study Completion Date
October 30, 2026
GentleFit Mask, Gentlefit Prong, Standard of Care Interface
The subject will be randomized to sequence of interfaces. The subject will wear each of three NIV interfaces for 8 cumulative hours, for a total of 24 hours. Pressure achieved using each GentleFit interface will be compared to pressure achieved by standard of care interface.
Children's Hospital of Philadelphia, Philadelphia
Children's Hospital of Philadelphia
OTHER