UnknownNot Applicable

A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support

Italy47 participantsStarted 2023-06

Plain-language summary

This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of this study is to assess, in a routine clinical environment at two centers the use of fabian-PRICO with noninvasive ventilation and its safety and performance at targeting and maintaining accurate SpO2 levels.

Who can participate

Age range0 Weeks – 37 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants in the neonatal unit that require non-invasive respiratory support and supplemental oxygen provided by fabian Therapy evolution ventilator * \<37 + 0 weeks gestation * \<10 kg at study entry * FiO2 \> 0.25 * Informed consent form obtained as per EC requirements Exclusion Criteria: * Not expected to complete 24 hours of non-invasive respiratory support * Congenital anomalies * Uncontrolled hemodynamics * Severe airflow obstruction * Intracranial hypertension * Start of caffeine therapy within 12 hours * Attending physician does not believe participation in the study is in the patient's best interest

What they're measuring

Target Range Compliance

Timeframe: 12 hours

Trial details

NCT IDNCT05823909

SponsorVyaire Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-06

Contact for this trial

Jens Krugmann, MD

+41 76 5090989 Jens.Krugmann@vyaire.com

View on ClinicalTrials.gov More Respiratory Insufficiency Syndrome of Newborn trials