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
Verified date | July 2022 |
Source | Vyaire Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Vyaire Medical |
Netherlands, Poland,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06249009 -
Diaphragmatic Work During HFNC and CPAP Support
|
N/A | |
Not yet recruiting |
NCT06364280 -
Pediatric Prehospital Airway Resuscitation Trial
|
N/A | |
Completed |
NCT05229172 -
Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)
|
||
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 |