Respiratory Insufficiency Syndrome of NewbornNCT05823909
A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support
An observational study of Respiratory Insufficiency Syndrome of Newborn, run by Vyaire Medical at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 37 weeks
- Conditions the study is for
- Respiratory Insufficiency Syndrome of Newborn
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2023to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 37 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Julie Tantau contact
Italy2 sites
Buzzi Children's Hospital
Milan
Gianluca Lista, MD
Fondazione IRCCS San Gerardo dei Tintori
Monza
Maria Luisa Ventura, MD
About this study
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.
Read the detailed description
This is a randomized cross-over study. Subjects will be assigned to two, nominally 12-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.
- Being tested
- fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation), fabian Therapy evolution ventilators with manual FiO2 control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)Device
12 hours Automated PRICO FiO2 control
fabian Therapy evolution ventilators with manual FiO2 controlDevice
12 hours Manual PRICO FiO2 control
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Range Compliance
Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%
Measured: 12 hours
Secondary outcomes (1)
Avoidance of SpO2 Extremes
Percentage of time that SpO2 is a) <80% and b) >98% when FiO2>21%
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency Syndrome of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vyaire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Luisa Ventura, MD, Principal investigator, Fondazione IRCCS San Gerardo dei TintoriGianluca Lista, MD, Principal investigator, Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823909
- Sponsor's protocol ID
- 100-P0310
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support
- ClinicalTrials.gov ID
- NCT05823909
- Acronym / sponsor ID
- 100-P0310
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Vyaire MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized cross-over study. Subjects will be assigned to two, nominally 12-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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Not expected to complete 24 hours of non-invasive respiratory support
- Congenital anomalies
- Uncontrolled hemodynamics
- Severe airflow obstruction
- Intracranial hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)12 hours Automated PRICO FiO2 control | Device | – |
| fabian Therapy evolution ventilators with manual FiO2 control12 hours Manual PRICO FiO2 control | Device | – |
Primary outcome
Target Range Compliance
Time frame: 12 hours
Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%
1 secondary outcome
Avoidance of SpO2 Extremes
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Tantau contact
Maria Luisa Ventura, MD principal investigator
Fondazione IRCCS San Gerardo dei Tintori
Gianluca Lista, MD principal investigator
Buzzi Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency Syndrome of Newborn, run by Vyaire Medical at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Krugmann, MD (+41 76 5090989, Jens.Krugmann@vyaire.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Range Compliance (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.