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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency in Children
• Intervention / Treatment: Device: fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function; Other: Manual Control

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC
• Poland
  • Kraków, Poland
    • Szpital Położniczo - Ginekologiczny Ujastek
  • Poznań, Poland
    • Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego
  • Szczecin, Poland
    • SPSK 2 Pomeranian Medical University
  • Warsaw, Poland
    • Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Members of the Investigational team will periodically review records to identify and maintain a pool of potential investigation candidates from the NICU. It is anticipated that this pool will be significantly larger than capacity of the team to enroll into the investigation.

The parents of potential candidates will be approached for discussion and consent prior to the desired intervention.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Range Compliance:	Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Avoidance of SpO2 Extremes:	Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%	24 hours

Collaborators and Investigators

• Sponsor: Vyaire Medical
• Investigators: Principal Investigator: Maria Wilińska, MD, PhD, Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw; Principal Investigator: Anton HLC van Kaam, Prof. MD PhD, University Medical Center, Amsterdam, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 21-001-PRICO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No