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

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.

• 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

Primary outcomes

• Target Range Compliance [12 hours]: Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%

Secondary outcomes

• Avoidance of SpO2 Extremes [12 hours]: Percentage of time that SpO2 is a) <80% and b) >98% when FiO2>21%

Sex: All, ages: 0 Weeks to 37 Weeks

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

• Maria Luisa Ventura, MD, Principal investigator, Fondazione IRCCS San Gerardo dei Tintori
• Gianluca Lista, MD, Principal investigator, Buzzi Children's Hospital