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PRICO: OPTI Target Range

NCT06207994 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-25

No results posted yet for this study

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

Interventions

DEVICE

Narrow TR

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

DEVICE

Shifted TR

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

Sponsors & Collaborators

  • University Hospital, Motol

    collaborator OTHER

  • Czech Technical University in Prague

    lead OTHER

Principal Investigators

  • Ekaterina Orlova, MD · Motol University Hospital Prague, Neonatal Unit

  • Jan Janota, MD, PhD · Motol University Hospital Prague, Neonatal Unit

  • Thomas E Bachman, MSc · Czech Technical University in Prague

  • Jana Dornakova, MD · Motol University Hospital Prague, Neonatal Unit

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06207994 on ClinicalTrials.gov