NCT05823909

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 47 (estimated)
• Sponsor: Vyaire Medical · Industry
• Sex: All
• Age: 0 Weeks – 37 Weeks
• Healthy volunteers: Not accepted

Summary

This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of this study is to assess, in a routine clinical environment at two centers the use of fabian-PRICO with noninvasive ventilation and its safety and performance at targeting and maintaining accurate SpO2 levels.

Detailed description

This is a randomized cross-over study. Subjects will be assigned to two, nominally 12-hour interventions, one with standard manual titration of FiO2 and the other with automated adjustment (PRICO). The order of these two interventions will be random. In addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the eCRF. This study has no additional follow-up visits.

Conditions

• Respiratory Insufficiency Syndrome of Newborn

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2023-04-21
• Last updated: 2023-04-21

Locations

2 sites across 1 country: Italy