PRICO: OPTI Target Range

Very Low Birth Weight Infant Clinical Trial

— POSTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207994
• Other study ID #: PricoOptiTR
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Czech Technical University in Prague
• Contact: Jakub Rafl, PhD
• Phone: +420728229991
• Email: rafl[@]fbmi.cvut.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Weeks and older

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

Related Conditions & MeSH terms

• Birth Weight
• Neonatal Respiratory Distress
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Very Low Birth Weight Infant

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Czechia	Motol University Hospital	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Czech Technical University in Prague	University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Associated effects	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.	30 days of intervention if possible
Other	Stability	Effects associated with infant stability will be explored. The stability will be assessed based on the mean time in the SpO2 target range.	30 days of intervention if possible
Primary	Percent time in the set SpO2 target range	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.	30 days of intervention if possible
Primary	Percent time at SpO2 =80% and >98%	Percent time at SpO2 =80% and >98% (safety). Periods with SpO2 higher than 98% with FiO2 = 0.21 will be excluded.	30 days of intervention if possible
Secondary	Percent time above the set SpO2 target range	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.	30 days of intervention if possible
Secondary	Percent time below the set SpO2 target range	Percent time below the set SpO2 target range.	30 days of intervention if possible