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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 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.
This is a randomized cross-over study. Subjects will be assigned to two, nominally 24-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 HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function | Device | 24 hours of automated control of FiO2 | ||
| Manual Control | Other | 24 hours of manual control of FiO2 |
| Measure | Description | Time Frame |
|---|---|---|
| Target Range Compliance: | Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21% | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Avoidance of SpO2 Extremes: | Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21% | 24 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.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Wilińska, MD, PhD | Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw | Principal Investigator |
| Anton HLC van Kaam, Prof. MD PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam | Netherlands | ||||
| Szpital Położniczo - Ginekologiczny Ujastek |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39019542 | Result | Wilinska M, Bachman T, Szczapa T, Wroblewska-Seniuk K, Chojnacka K, Loniewska B, Olszanska K, Rzepecka Weglarz B, Janusz K, Piwowarczyk P, Onland W, Hutten GJ, van Leuteren RW, van Kaam AH. Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study). BMJ Paediatr Open. 2024 Jul 16;8(1):e002583. doi: 10.1136/bmjpo-2024-002583. |
| Label | URL |
|---|---|
| Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study) | View source |
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| Krakow |
| Poland |
| Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego | Poznan | Poland |
| SPSK 2 Pomeranian Medical University | Szczecin | Poland |
| Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw | Warsaw | Poland |