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

Vyaire Medical

Status: Not yet enrolling

Conditions: Respiratory Insufficiency Syndrome of Newborn

Treatments: Device: fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation); Device: fabian Therapy evolution ventilators with manual FiO2 control

Study type: Observational

Funder types: Industry

Identifiers

NCT05823909

100-P0310

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 47 estimated patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No Healthy Volunteers

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