Clinical trial NCT05823909: A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support
Official title: A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Insufficiency Syndrome of Newborn
Lead sponsor: Vyaire Medical
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 47
Sex: ALL
Minimum age (years): 0
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Target Range Compliance
timeFrame: 12 hours
Secondary outcomes:
measure: Avoidance of SpO2 Extremes
timeFrame: 12 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Buzzi Children's Hospital
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
Study officials:
affiliation: Fondazione IRCCS San Gerardo dei Tintori
name: Maria Luisa Ventura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buzzi Children's Hospital
name: Gianluca Lista, MD
role: PRINCIPAL_INVESTIGATOR
References: