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 range

0 Weeks – 37 Weeks

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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