Status:

RECRUITING

Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates

Lead Sponsor:

Medical University of Graz

Conditions:

Neonatal Infection

Preterm Birth

Eligibility:

All Genders

Up to 6 years

Brief Summary

This is a prospective observational pilot study investigating if peripheral fractional tissue oxygen extraction (pFTOE) measured by five short near-infrared spectroscopy (NIRS) (re-)applications withi...

Detailed Description

Background Near-infrared spectroscopy (NIRS) enables non-invasive, continuous monitoring of oxygenation and perfusion in different tissues. In several studies NIRS has been described to have the poten...

Eligibility Criteria

Inclusion

  • Signs of respiratory distress at time-point of inclusion (tachypnoea \>60/minutes, grunting, intercostal/subcostal/jugular retractions, nasal flaring, supplemental oxygen or respiratory upport)
  • Decision to conduct full life support
  • Written informed consent
  • Age \< 6 hours

Exclusion

  • No decision to conduct full life support
  • no written informed consent
  • gestational age \<30+0 weeks of gestation
  • age \> 6 hours
  • severe congenital malformations, severe asphyxia (umbilical cord artery pH \<7.00)

Key Trial Info

Start Date :

February 26 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04818762

Start Date

February 26 2021

End Date

February 1 2026

Last Update

March 13 2025

Active Locations (1)

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Department of Pediatrics, Division of Neonatology, Medical University of Graz

Graz, Styria, Austria, 8036