NCT05823909View on ClinicalTrials.gov

A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support

UnknownOBSERVATIONAL
Enrollment

47

Participants

Timeline

Start Date

June 30, 2023

Primary Completion Date

June 30, 2024

Study Completion Date

August 31, 2024

Conditions
Respiratory Insufficiency Syndrome of Newborn
Interventions
DEVICE

fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)

12 hours Automated PRICO FiO2 control

DEVICE

fabian Therapy evolution ventilators with manual FiO2 control

12 hours Manual PRICO FiO2 control

Trial Locations (2)

Unknown

Buzzi Children's Hospital, Milan

Fondazione IRCCS San Gerardo dei Tintori, Monza

Sponsors

Lead Sponsor

Vyaire Medical
All Listed Sponsors
lead

Vyaire Medical

INDUSTRY

NCT05823909 - A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support | Biotech Hunter | Biotech Hunter