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

NCT04957472 | Completed DMC

• 1 other identifier: 21-001-PRICO
• Study Type: observational
• Target: 47
• Locations: 2 countries
• Sites: 5

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.

Conditions

Respiratory Insufficiency in Children

Outcome Measures

Primary Outcomes (1)

• Target Range Compliance:

  Percent-Time with SpO2 a) \<80% and b) with \>98% SpO2 with FiO2\>21%

  24 hours

Secondary Outcomes (1)

• Avoidance of SpO2 Extremes:

  24 hours

Interventions

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

24 hours of automated control of FiO2

Manual Control OTHER

24 hours of manual control of FiO2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyaire Medical: lead

Study Sites (5)

Amsterdam UMC

Amsterdam, Netherlands

Location

Szpital Położniczo - Ginekologiczny Ujastek

Krakow, Poland

Location

Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego

Poznan, Poland

Location

SPSK 2 Pomeranian Medical University

Szczecin, Poland

Location

Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw

Warsaw, Poland

Location

Related Publications (1)

• Wilinska M, Bachman T, Szczapa T, Wroblewska-Seniuk K, Chojnacka K, Loniewska B, Olszanska K, Rzepecka Weglarz B, Janusz K, Piwowarczyk P, Onland W, Hutten GJ, van Leuteren RW, van Kaam AH. Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study). BMJ Paediatr Open. 2024 Jul 16;8(1):e002583. doi: 10.1136/bmjpo-2024-002583.

  PMID: 39019542 RESULT

Related Links

• Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study)

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 12, 2021
• Study Start: January 14, 2022
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); NL (1)