NCT04957472

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Vyaire Medical · Industry
• Sex: All
• Age: —
• 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 the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.

Detailed description

This is a randomized cross-over study. Subjects will be assigned to two, nominally 24-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 in Children

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-14
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2021-07-12
• Last updated: 2024-08-23

Locations

5 sites across 2 countries: Netherlands, Poland