Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-02-20
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Target Range
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.
No interventions assigned to this group
Narrow Target Range
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.
Narrow TR
The width of the PRICO SpO2 TR is set to 3% SpO2.
Shifted Target Range
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.
Shifted TR
The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.
Interventions
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Narrow TR
The width of the PRICO SpO2 TR is set to 3% SpO2.
Shifted TR
The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Recording device for automated control of FiO2 is not available
2 Weeks
ALL
No
Sponsors
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University Hospital, Motol
OTHER
Czech Technical University in Prague
OTHER
Responsible Party
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Principal Investigators
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Ekaterina Orlova, MD
Role: PRINCIPAL_INVESTIGATOR
Motol University Hospital Prague, Neonatal Unit
Jan Janota, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Motol University Hospital Prague, Neonatal Unit
Thomas E Bachman, MSc
Role: PRINCIPAL_INVESTIGATOR
Czech Technical University in Prague
Jana Dornakova, MD
Role: PRINCIPAL_INVESTIGATOR
Motol University Hospital Prague, Neonatal Unit
Locations
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Motol University Hospital
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PricoOptiTR
Identifier Type: -
Identifier Source: org_study_id
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