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

Respiratory Insufficiency Syndrome of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05823909
• Other study ID #: 100-P0310
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2023
• Source: Vyaire Medical
• Contact: Jens Krugmann, MD
• Phone: +41 76 5090989
• Email: Jens.Krugmann[@]vyaire.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 47
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Respiratory Insufficiency Syndrome of Newborn

Intervention

Device:
• fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)
12 hours Automated PRICO FiO2 control
• fabian Therapy evolution ventilators with manual FiO2 control
12 hours Manual PRICO FiO2 control

Locations

Country	Name	City	State
Italy	Buzzi Children's Hospital	Milan
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza

Sponsors (1)

Lead Sponsor	Collaborator
Vyaire Medical

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Range Compliance	Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%	12 hours
Secondary	Avoidance of SpO2 Extremes	Percentage of time that SpO2 is a) <80% and b) >98% when FiO2>21%	12 hours