Respiratory Insufficiency in ChildrenNCT04957472
Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU
An observational study of Respiratory Insufficiency in Children, run by Vyaire Medical at 5 sites in 2 countries.
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 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Insufficiency in Children
- What is being tested?
- fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 14 Jan 2022to 28 Oct 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Poland4 sites
Szpital Położniczo - Ginekologiczny Ujastek
Krakow
Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. K. Marcinkowskiego
Poznan
SPSK 2 Pomeranian Medical University
Szczecin
Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw
Warsaw
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 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.
Read the 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.
- Conditions
- Respiratory Insufficiency in Children
- Being tested
- fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function, Manual Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO functionDevice
24 hours of automated control of FiO2
Manual ControlOther
24 hours of manual control of FiO2
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Range Compliance:
Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%
Measured: 24 hours
Secondary outcomes (1)
Avoidance of SpO2 Extremes:
Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start14 Jan 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Insufficiency in ChildrenStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Vyaire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Wilińska, MD, PhD, Principal investigator, Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego WarsawAnton HLC van Kaam, Prof. MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957472
- Sponsor's protocol ID
- 21-001-PRICO
- Status last verified
- Aug 2024
- First submitted
- 30 Jun 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39019542
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU
- ClinicalTrials.gov ID
- NCT04957472
- Acronym / sponsor ID
- 21-001-PRICO
- Conditions
- Respiratory Insufficiency in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Vyaire MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 12 Jul 2021 (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 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 (3 listed)
- 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
Key exclusion criteria (7 listed)
- Not expected to complete 48 hours of the current respiratory support therapeutic category
- 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 HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function24 hours of automated control of FiO2 | Device | – |
| Manual Control24 hours of manual control of FiO2 | Other | – |
Primary outcome
Target Range Compliance:
Time frame: 24 hours
Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%
1 secondary outcome
Avoidance of SpO2 Extremes:
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Results publication: PubMed 39019542Wilinska 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.
- Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study)Link provided by the sponsor.
- 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.
Maria Wilińska, MD, PhD principal investigator
Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego Warsaw
Anton HLC van Kaam, Prof. MD PhD principal investigator
Amsterdam UMC, location VUmc
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency in Children, run by Vyaire Medical at 5 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Range Compliance: (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04957472, which also lists 1 linked publication.
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 23 Aug 2024.