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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation) | Device | 12 hours Automated PRICO FiO2 control | ||
| fabian Therapy evolution ventilators with manual FiO2 control | Device | 12 hours Manual PRICO FiO2 control |
| Measure | Description | Time Frame |
|---|---|---|
| Target Range Compliance | Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21% | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Avoidance of SpO2 Extremes | Percentage of time that SpO2 is a) <80% and b) >98% when FiO2>21% | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Krugmann, MD | Contact | +41 76 5090989 | Jens.Krugmann@vyaire.com | |
| Julie Tantau | Contact | Julie.wTantau@vyaire.com |
| Name | Affiliation | Role |
|---|---|---|
| Maria Luisa Ventura, MD | Fondazione IRCCS San Gerardo dei Tintori | Principal Investigator |
| Gianluca Lista, MD | Buzzi Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buzzi Children's Hospital | Milan | Italy |
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| Fondazione IRCCS San Gerardo dei Tintori | Monza | Italy |
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