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

NCT04957472 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2024-08-23

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 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.

Conditions

  • Respiratory Insufficiency in Children

Interventions

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

Sponsors & Collaborators

  • Vyaire Medical

    lead INDUSTRY

Principal Investigators

  • Maria Wilińska, MD, PhD · Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw

  • Anton HLC van Kaam, Prof. MD PhD · University Medical Center, Amsterdam, The Netherlands

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2022-10-28
Completion
2022-10-28

Countries

  • Netherlands
  • Poland

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 NCT04957472 on ClinicalTrials.gov