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

Respiratory Insufficiency in Children Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Respiratory Insufficiency in Children

• NCT number: NCT04957472
• Study type: Observational
• Source: Vyaire Medical
• Status: Completed
• Start date: January 14, 2022
• Completion date: October 28, 2022