15
Participants
Start Date
September 2, 2021
Primary Completion Date
October 19, 2023
Study Completion Date
October 19, 2023
Automated Control
The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.
Manual Control
The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.
Children's National Hospital & Research Institute, Washington D.C.
University of Utah Hospital, Salt Lake City
Seattle Children's Hospital, Seattle
Collaborators (1)
Children's National Research Institute
OTHER
Seattle Children's Hospital
OTHER
University of Utah
OTHER
Vapotherm, Inc.
INDUSTRY