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

Respiratory Insufficiency in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957472
• Other study ID #: 21-001-PRICO
• Status: Completed
• Start date: January 14, 2022
• Est. completion date: October 28, 2022

Study information

• Verified date: July 2022
• Source: Vyaire Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Respiratory Insufficiency in Children

Intervention

Device:
• fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function
24 hours of automated control of FiO2

Other:
• Manual Control
24 hours of manual control of FiO2

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Poland	Szpital Polozniczo - Ginekologiczny Ujastek	Kraków
Poland	Ginekologiczno-Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego	Poznan
Poland	SPSK 2 Pomeranian Medical University	Szczecin
Poland	Centre of Postgraduate Medical Education, SPSK im prof.W.Orlowskiego Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Vyaire Medical

Countries where clinical trial is conducted

Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Range Compliance:	Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%	24 hours
Secondary	Avoidance of SpO2 Extremes:	Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%	24 hours