PRICO: OPTI Target Range

Not Applicable

Recruiting

• Conditions: Neonatal Respiratory Distress; Very Low Birth Weight Infant
• Interventions: Device: Narrow TR; Device: Shifted TR

• Registration Number: NCT06207994
• Lead Sponsor: Czech Technical University in Prague

Brief 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

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 Timeline

• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-17
• Study Start: 2024-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Narrow Target Range	Narrow TR	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.
Shifted Target Range	Shifted TR	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.

Primary Outcome Measures

Name	Time	Method
Percent time in the set SpO2 target range	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%	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 Outcome Measures

Name	Time	Method
Percent time above the set SpO2 target range	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.
Percent time below the set SpO2 target range	30 days of intervention if possible	Percent time below the set SpO2 target range.

Trial Locations

Locations (1)

Motol University Hospital; 🇨🇿 Prague, Czechia