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

Not yet recruiting

• Conditions: Respiratory Insufficiency Syndrome of Newborn

• Registration Number: NCT05823909
• Lead Sponsor: Vyaire Medical

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Last Update Submitted: 2023-04-10
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Study Start: 2023-06
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Buzzi Children's Hospital; 🇮🇹 Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Italy