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

Vyaire Medical

Status: Completed

Conditions: Respiratory Insufficiency in Children

Treatments: Device: fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function; Other: Manual Control

Study type: Observational

Funder types: Industry

Identifiers

NCT04957472

21-001-PRICO

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 47 patients

Sex: All

Volunteers: No Healthy Volunteers

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.