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

Completed

• Conditions: Respiratory Insufficiency in Children

• Registration Number: NCT04957472
• 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 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.

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 Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-12
• Study Start: 2022-01-14
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

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

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Range Compliance:	24 hours	Percent-Time with SpO2 a) \<80% and b) with \>98% SpO2 with FiO2\>21%

Secondary Outcome Measures

Name	Time	Method
Avoidance of SpO2 Extremes:	24 hours	Percent-Time with SpO2 a) \<80% and b) with \>98% SpO2 with FiO2\>21%

Trial Locations

Locations (5)

Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw; 🇵🇱 Warsaw, Poland

Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego; 🇵🇱 Poznań, Poland

SPSK 2 Pomeranian Medical University; 🇵🇱 Szczecin, Poland

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Szpital Położniczo - Ginekologiczny Ujastek; 🇵🇱 Kraków, Poland