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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Respiratory Insufficiency Syndrome of Newborn

Intervention / Treatment
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* Device: fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)
* Device: fabian Therapy evolution ventilators with manual FiO2 control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)|12 hours Automated PRICO FiO2 control|
|Device: fabian Therapy evolution ventilators with manual FiO2 control|12 hours Manual PRICO FiO2 control|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Range Compliance | 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 | Percentage of time that SpO2 is a) <80% and b) >98% when FiO2>21% | 12 hours |