PRICO: OPTI Target Range (POSTR)

Czech Technical University in Prague

Status: Enrolling

Conditions: Very Low Birth Weight Infant; Neonatal Respiratory Distress

Treatments: Device: Narrow TR; Device: Shifted TR

Study type: Interventional

Funder types: Other

Identifiers

NCT06207994

PricoOptiTR

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 2+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Standard Target Range

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Narrow TR

Shifted Target Range

Experimental group

Description:

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.

Treatment:

Device: Shifted TR