Neonatal Respiratory DistressPOSTRNCT06207994
PRICO: OPTI Target Range
A study testing Narrow TR and Shifted TR in people with Neonatal Respiratory Distress and Very Low Birth Weight Infant, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range Read more about this study
- Who is it for?
- Ages 2 weeks and older
- Conditions the study is for
- Neonatal Respiratory Distress, Very Low Birth Weight Infant
- What is being tested?
- Narrow TR and Shifted TR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Feb 2024to 30 Nov 2025
- Phase
- Interventional
- 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 2 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained.
Who cannot join
- Informed consent is not obtained
- Recording device for automated control of FiO2 is not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of a Narrower SpO2 Target Range on Performance of an Automatic FiO2 Control System: a Randomized Study
The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range
Read the detailed description
A-FiO2 systems have consistently proven to be more effective than manual control. Because it is more precise than manual control, studies of some A-FiO2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. Similar studies of the A-FiO2 system (PRICO) used in the investigator's NICU have not been conducted.
The standard of practice in the investigator's NICU is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. Based on the studies of other A-FiO2 systems the investigators believe a slightly narrower width target range would be more effective. Therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal.
- Being tested
- Narrow TR, Shifted TR
- Keywords
- SpO2 Target Range, pulse oximetry, automatic oxygen control
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow TRDevice
The width of the PRICO SpO2 TR is set to 3% SpO2.
Shifted TRDevice
The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.
| Study group | Role | What they receive |
|---|---|---|
| Standard Target Range | No intervention | The SpO2 TR width is set to 5% SpO2, as is routine in the department. The actual TR will vary depending on the GA, as is standard practice in the department. |
| Narrow Target Range | Experimental | The SpO2 TR width is set narrower than the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department. Receives: Device: Narrow TR |
| Shifted Target Range | Experimental | The SpO2 TR width is set as the Standard TR. The median of the TR is shifted up compared to the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department. Receives: Device: Shifted TR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time in the set SpO2 target range
Percent time in the set SpO2 target range (compliance). Periods with SpO2 higher than the target range with FiO2 = 0.21 will be included in the target range compliance.
Measured: 30 days of intervention if possible
Percent time at SpO2 ≤80% and >98%
Percent time at SpO2 ≤80% and >98% (safety). Periods with SpO2 higher than 98% with FiO2 = 0.21 will be excluded.
Measured: 30 days of intervention if possible
Secondary outcomes (2)
Percent time above the set SpO2 target range
Percent time above the set SpO2 target range. Periods with SpO2 higher than the target range with FiO2 = 0.21 will be excluded from time above the target range.
Measured: 30 days of intervention if possible
Percent time below the set SpO2 target range
Percent time below the set SpO2 target range.
Measured: 30 days of intervention if possible
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start20 Feb 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be switched between the standard target range, the narrow target range, and the target range with a higher median every 12 hours. The sequence will be randomized differently for each subject, with a balanced block design such that every 3 days each range is evaluated twice. Once enrolled, each subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2 or 30 days, whichever is shorter. All other elements of care will be as routinely used.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Motol
- Responsible party
- Sponsor
- Investigators
- Ekaterina Orlova, MD, Principal investigator, Motol University Hospital Prague, Neonatal UnitJan Janota, MD, PhD, Principal investigator, Motol University Hospital Prague, Neonatal UnitThomas E Bachman, MSc, Principal investigator, Czech Technical University in PragueJana Dornakova, MD, Principal investigator, Motol University Hospital Prague, Neonatal Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207994
- Sponsor's protocol ID
- PricoOptiTR
- Acronym
- POSTR
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be made available upon reasonable request in a deidentified, HIPAA-compliant form.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Narrower SpO2 Target Range on Performance of an Automatic FiO2 Control System: a Randomized Study
- ClinicalTrials.gov ID
- NCT06207994
- Acronym / sponsor ID
- POSTR / PricoOptiTR
- Keywords
- SpO2 Target Range, pulse oximetry, automatic oxygen control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- University Hospital, Motol
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 17 Jan 2024 (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.
The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range
Detailed description
A-FiO2 systems have consistently proven to be more effective than manual control. Because it is more precise than manual control, studies of some A-FiO2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. Similar studies of the A-FiO2 system (PRICO) used in the investigator's NICU have not been conducted.
The standard of practice in the investigator's NICU is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. Based on the studies of other A-FiO2 systems the investigators believe a slightly narrower width target range would be more effective. Therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be switched between the standard target range, the narrow target range, and the target range with a higher median every 12 hours. The sequence will be randomized differently for each subject, with a balanced block design such that every 3 days each range is evaluated twice. Once enrolled, each subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2 or 30 days, whichever is shorter. All other elements of care will be as routinely used.
| Arm | Type | Receives |
|---|---|---|
| Standard Target Range | No intervention | –The SpO2 TR width is set to 5% SpO2, as is routine in the department. The actual TR will vary depending on the GA, as is standard practice in the department. |
| Narrow Target Range | Experimental | Device: Narrow TRThe SpO2 TR width is set narrower than the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department. |
| Shifted Target Range | Experimental | Device: Shifted TRThe SpO2 TR width is set as the Standard TR. The median of the TR is shifted up compared to the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department. |
Who may qualify
- Ages
- 2 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained.
Key exclusion criteria (2 listed)
- Informed consent is not obtained
- Recording device for automated control of FiO2 is not available
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 |
|---|---|---|
| Narrow TRThe width of the PRICO SpO2 TR is set to 3% SpO2. | Device | Narrow Target Range |
| Shifted TRThe lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2. | Device | Shifted Target Range |
Primary outcome
Percent time in the set SpO2 target range
Time frame: 30 days of intervention if possible
Percent time in the set SpO2 target range (compliance). Periods with SpO2 higher than the target range with FiO2 = 0.21 will be included in the target range compliance.
Percent time at SpO2 ≤80% and >98%
Time frame: 30 days of intervention if possible
Percent time at SpO2 ≤80% and >98% (safety). Periods with SpO2 higher than 98% with FiO2 = 0.21 will be excluded.
2 secondary outcomes
Percent time above the set SpO2 target range
Time frame: 30 days of intervention if possible
Percent time below the set SpO2 target range
Time frame: 30 days of intervention if possible
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 16 Jun 2026.
- Individual participant dataSharing planned: Yes. The IPD will be made available upon reasonable request in a deidentified, HIPAA-compliant form.
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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.
Ekaterina Orlova, MD principal investigator
Motol University Hospital Prague, Neonatal Unit
Jan Janota, MD, PhD principal investigator
Motol University Hospital Prague, Neonatal Unit
Thomas E Bachman, MSc principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow TR and Shifted TR in people with Neonatal Respiratory Distress and Very Low Birth Weight Infant, run by Czech Technical University in Prague at 1 site in Czechia.
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 1 inclusion and 2 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Percent time in the set SpO2 target range (time frame: 30 days of intervention if possible). The study lists 2 primary outcomes in all. 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 16 Jun 2026.