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

NCT05823909 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2023-04-21

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Vyaire Medical

    lead INDUSTRY

Principal Investigators

  • Maria Luisa Ventura, MD · Fondazione IRCCS San Gerardo dei Tintori

  • Gianluca Lista, MD · Buzzi Children's Hospital

Eligibility

Min Age
0 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-06-30
Completion
2024-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05823909 on ClinicalTrials.gov