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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04957472

Enrollment

Registered

2021-07-12

Start date

2022-01-14

Completion date

2022-10-28

Last updated

2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency in Children

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.

Interventions

DEVICEfabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function

24 hours of automated control of FiO2

OTHERManual Control

24 hours of manual control of FiO2

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026