Clinical trial NCT04957472: Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU
Official title: Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency in Children
Lead sponsor: Vyaire Medical
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Target Range Compliance:
timeFrame: 24 hours
Secondary outcomes:
measure: Avoidance of SpO2 Extremes:
timeFrame: 24 hours
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Kraków
country: Poland
facility: Szpital Położniczo - Ginekologiczny Ujastek
city: Poznań
country: Poland
facility: Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego
city: Szczecin
country: Poland
facility: SPSK 2 Pomeranian Medical University
city: Warsaw
country: Poland
facility: Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw
Study officials:
affiliation: Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw
name: Maria Wilińska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center, Amsterdam, The Netherlands
name: Anton HLC van Kaam, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.