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PRICO: OPTI Target Range

PRICO: OPTI Target Range

Recruiting
2 years and older
All
Phase N/A

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Overview

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

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.

Eligibility

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

Study details
    Neonatal Respiratory Distress
    Very Low Birth Weight Infant

NCT06207994

Czech Technical University in Prague

21 October 2025

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