Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU

CompletedOBSERVATIONAL
Enrollment

47

Participants

Timeline

Start Date

January 14, 2022

Primary Completion Date

October 28, 2022

Study Completion Date

October 28, 2022

Conditions
Respiratory Insufficiency in Children
Interventions
DEVICE

fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function

24 hours of automated control of FiO2

OTHER

Manual Control

24 hours of manual control of FiO2

Trial Locations (5)

Unknown

Amsterdam UMC, Amsterdam

Szpital Położniczo - Ginekologiczny Ujastek, Krakow

Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego, Poznan

SPSK 2 Pomeranian Medical University, Szczecin

Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Vyaire Medical

INDUSTRY

NCT04957472 - Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU | Biotech Hunter | Biotech Hunter