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Completed

NCT Number: NCT06207994

PRICO: OPTI Target Range

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

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Key information

Conditions

Neonatal Respiratory Distress Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases Very Low Birth Weight Infant

Age range

2 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motol University Hospital

Prague, 15500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained.

Exclusion criteria

  • Informed consent is not obtained
  • Recording device for automated control of FiO2 is not available

Treatment and study plan

Narrow TR

Device

The width of the PRICO SpO2 TR is set to 3% SpO2.

Shifted TR

Device

The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Percent time above the set SpO2 target range

    Time frame: 30 days of intervention if possible

    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.

  2. Percent time below the set SpO2 target range

    Time frame: 30 days of intervention if possible

    Percent time below the set SpO2 target range.

Other outcomes

  1. Associated effects

    Time frame: 30 days of intervention if possible

    Effects associated with the mode of ventilation and set SpO2 control (based on gestational age) will be explored. The effects will be treated as covariables in a multivariate linear regression model with SpO2 target range compliance as a dependent variable.

  2. Stability

    Time frame: 30 days of intervention if possible

    Effects associated with infant stability will be explored. The stability will be assessed based on the mean time in the SpO2 target range.

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Collaborators

  • University Hospital, Motol

Registry information

Official study title

Evaluation of the Impact of a Narrower SpO2 Target Range on Performance of an Automatic FiO2 Control System: a Randomized Study

Acronym: POSTR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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