A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support
1 other identifier
observational
47
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedApril 21, 2023
April 1, 2023
1 year
April 10, 2023
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Target Range Compliance
Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%
12 hours
Secondary Outcomes (1)
Avoidance of SpO2 Extremes
12 hours
Interventions
12 hours Automated PRICO FiO2 control
12 hours Manual PRICO FiO2 control
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vyaire Medicallead
Study Sites (2)
Buzzi Children's Hospital
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Luisa Ventura, MD
Fondazione IRCCS San Gerardo dei Tintori
- PRINCIPAL INVESTIGATOR
Gianluca Lista, MD
Buzzi Children's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2023
First Posted
April 21, 2023
Study Start
June 1, 2023
Primary Completion
June 1, 2024
Study Completion
August 1, 2024
Last Updated
April 21, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share