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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04957472
Other study ID # 21-001-PRICO
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT03824249 - Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation N/A
Recruiting NCT05418530 - Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics Randomized, Crossover Clinical Study N/A