Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU

Vyaire Medical47 enrolled

Overview

This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.

This is a randomized cross-over study. Subjects will be assigned to two, nominally 24-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 Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Insufficiency in Children

Interventions

fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO functionDEVICE

24 hours of automated control of FiO2

Manual ControlOTHER

24 hours of manual control of FiO2

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Respiratory insufficiency of infants in the neonatal unit who require respiratory support and supplemental oxygen in one of 4 the therapeutic categories (Intubated HFO, Intubated CMV, Non-Invasive nasal mask, nasal cannula). * \<30 kg at study entry * Informed Consent Form obtained as per EC requirement Exclusion Criteria: * Not expected to complete 48 hours of the current respiratory support therapeutic category * Congenital anomalies * Uncontrolled hemodynamics * Severe airflow obstruction * Intracranial hypertension * Start of caffeine therapy within 12 hours * Attending physician does not believe participation of the patient is in their best interest.

Locations (5)

Amsterdam UMC

Amsterdam, Netherlands

Szpital Położniczo - Ginekologiczny Ujastek

Krakow, Poland

Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego

Poznan, Poland

SPSK 2 Pomeranian Medical University

Szczecin, Poland

Outcomes

Primary Outcomes

Target Range Compliance:

Percent-Time with SpO2 a) \<80% and b) with \>98% SpO2 with FiO2\>21%

Time frame: 24 hours

Secondary Outcomes

Avoidance of SpO2 Extremes:

Percent-Time with SpO2 a) \<80% and b) with \>98% SpO2 with FiO2\>21%

Time frame: 24 hours

Data from ClinicalTrials.gov

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