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

April 10, 2023 updated by: Vyaire Medical
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy
        • Buzzi Children's Hospital
        • Contact:
          • Gianluca Lista, MD
      • Monza, Italy
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
          • Maria Luisa Ventura, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Members of the Investigational team will periodically review records to identify and maintain a pool of potential investigation candidates from the NICU. It is anticipated that this pool will be significantly larger than capacity of the team to enroll into the investigation.

The parents of potential candidates will be approached for discussion and consent prior to the desired intervention.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Range Compliance
Time Frame: 12 hours
Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Avoidance of SpO2 Extremes
Time Frame: 12 hours
Percentage of time that SpO2 is a) <80% and b) >98% when FiO2>21%
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-P0310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Insufficiency Syndrome of Newborn

Clinical Trials on fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe