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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05823909

Enrollment

Registered

2023-04-21

Start date

2023-06-30

Completion date

2024-08-31

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency Syndrome of Newborn

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.

Interventions

DEVICEfabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)

12 hours Automated PRICO FiO2 control

DEVICEfabian Therapy evolution ventilators with manual FiO2 control

12 hours Manual PRICO FiO2 control

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Weeks to 37 Weeks

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

Design outcomes

Primary

Measure	Time frame	Description
Target Range Compliance	12 hours	Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%

Secondary

Measure	Time frame	Description
Avoidance of SpO2 Extremes	12 hours	Percentage of time that SpO2 is a) \<80% and b) \>98% when FiO2\>21%

Countries

Italy

Contacts

Primary ContactJens Krugmann, MD

Jens.Krugmann@vyaire.com+41 76 5090989

Backup ContactJulie Tantau

Julie.wTantau@vyaire.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026