PRICO: OPTI Target Range

NCT06207994 | Recruiting

• 1 other identifier: PricoOptiTR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal Respiratory Distress; Very Low Birth Weight Infant

Keywords

SpO2 Target Range; pulse oximetry; automatic oxygen control

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Percent time above the set SpO2 target range

  30 days of intervention if possible

• Percent time below the set SpO2 target range

  30 days of intervention if possible

Other Outcomes (2)

• Associated effects

  30 days of intervention if possible

• Stability

  30 days of intervention if possible

Study Arms (3)

Standard Target Range

NO INTERVENTION

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

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.

Device: Narrow TR

Shifted Target Range

EXPERIMENTAL

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.

Device: Shifted TR

Interventions

Narrow TR DEVICE

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

Narrow Target Range

Shifted TR DEVICE

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

Shifted Target Range

Eligibility Criteria

• Age: 2 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Czech Technical University in Prague: lead
• University Hospital, Motol: collaborator

Study Sites (1)

Motol University Hospital

Prague, 15500, Czechia

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ekaterina Orlova, MD

  Motol University Hospital Prague, Neonatal Unit

  PRINCIPAL INVESTIGATOR

• Jan Janota, MD, PhD

  Motol University Hospital Prague, Neonatal Unit

  PRINCIPAL INVESTIGATOR

• Thomas E Bachman, MSc

  Czech Technical University in Prague

  PRINCIPAL INVESTIGATOR

• Jana Dornakova, MD

  Motol University Hospital Prague, Neonatal Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub Rafl, PhD

CONTACT

+420728229991; rafl@fbmi.cvut.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be switched between the standard target range, the narrow target range, and the target range with a higher median every 12 hours. The sequence will be randomized differently for each subject, with a balanced block design such that every 3 days each range is evaluated twice. Once enrolled, each subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2 or 30 days, whichever is shorter. All other elements of care will be as routinely used.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 17, 2024
• Study Start: February 20, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)