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

Sponsor
Vyaire Medical (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05823909
Collaborator
(none)
47
Enrollment
2
Locations
14
Anticipated Duration (Months)
23.5
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)
  • Device: fabian Therapy evolution ventilators with manual FiO2 control

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
47 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Target Range Compliance [12 hours]

    Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%

Secondary Outcome Measures

  1. Avoidance of SpO2 Extremes [12 hours]

    Percentage of time that SpO2 is a) <80% and b) >98% when FiO2>21%

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Weeks to 37 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Infants in the neonatal unit that require non-invasive respiratory support and supplemental oxygen provided by fabian Therapy evolution ventilator

  • <37 + 0 weeks gestation

  • <10 kg at study entry

  • FiO2 > 0.25

  • Informed consent form obtained as per EC requirements

Exclusion Criteria:

  • Not expected to complete 24 hours of non-invasive respiratory support

  • Congenital anomalies

  • Uncontrolled hemodynamics

  • Severe airflow obstruction

  • Intracranial hypertension

  • Start of caffeine therapy within 12 hours

  • Attending physician does not believe participation in the study is in the patient's best interest

Contacts and Locations

Locations

Site City State Country Postal Code
1 Buzzi Children's Hospital Milan Italy
2 Fondazione IRCCS San Gerardo dei Tintori Monza Italy

Sponsors and Collaborators

  • Vyaire Medical

Investigators

  • Principal Investigator: Maria Luisa Ventura, MD, Fondazione IRCCS San Gerardo dei Tintori
  • Principal Investigator: Gianluca Lista, MD, Buzzi Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vyaire Medical
ClinicalTrials.gov Identifier:
NCT05823909
Other Study ID Numbers:
  • 100-P0310
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Insufficiency

Study Results

No Results Posted as of Apr 21, 2023