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NCT Number: NCT04818762

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

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 within the first 6 hours after birth in neonates with respiratory distress differs in neonates with early onset infection and neonate without infection

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Key information

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Graz, Styria, 8036, Austria

Location status: Recruiting

Location contact

Gerhard Pichler, MD

CONTACT

[email protected]

0043 316 385 80520

Gerhard Pichler, MD

PRINCIPAL_INVESTIGATOR

About this study

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 potential to detect centralisation due to perfusion heterogeneity, arterio-venous shunting and impaired autoregulation. Thus, peripheral muscle NIRS measurement has the potential to provide information at early stages of inflammation also due to infection, due to microvascular dysfunction, when other routine vital parameters are still within normal ranges.

Objectives

Primary aim To assess, if pFTOE measured by five short NIRS (re-)applications within the first 6 hours after birth differs in neonates with early onset infection and neonates without infection.

Secondary aims To assess, if cerebral fractional tissue oxygen extraction (cFTOE) and cFTOE/pFTOE measured by five short NIRS (re-)applications within the first 6 hours after birth differs in neonates with early onset infection and neonates without infection. To assess, if there is a difference in pFTOE, cFTOE and cFTOE/pFTOE between term and preterm neonates.

Methods

Study population: Term and preterm neonates ≥30+0 weeks of gestation with respiratory distress and risk factors for infection admitted to the neonatal intensive care unit (NICU) on the first day after vaginal delivery or caesarean section on the first day after birth will be eligible for this study. Inclusion criteria are signs of respiratory distress at time-point of inclusion, age <6h and decision to conduct full life support. There will be four groups consisted with term(1) and preterm(2) neonates with early onset infection and term(3) and preterm(4) neonates without.

Procedure: Patients and maternal medical history, routinely sampled laboratory results and blood culture will be documented in each neonate.

Measurement: The NIRS-measurement will take place once within 6 hours after birth. For NIRS measurements the NIRO 200NX will be used and the NIRS sensors will be applied by hand on the right forearm (pTOI) and on the left forehead (cTOI) until stable signals are obtained for approximately 30 seconds, respectively. Then the sensors will be removed for 10sec rest period. After that the sensors will be reapplied in approximately the same positions. This procedure will be repeated five times.

Level of originality As many term and preterm neonates are admitted to the NICU after birth due to respiratory distress, there is growing interest in methods enabling to recognize subtle early signs like micro-vascular dysfunction due to infection. In the present study the investigators want to evaluate in neonates with respiratory distress if peripheral muscle and cerebral FTOE measured by short reapplications with NIRS in the first hours after birth enables to recognize early microvascular dysfunction and compromised oxygenation due to infections.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. pFTOE

    Time frame: 5 minutes (duration of 5 re-applications)

    pFTOE within 6 hours after birth

Secondary outcomes

  1. cFTOE

    Time frame: 5 minutes (duration of 5 re-applications)

    cFTOE and cFTOE/pFTOE within 6 hours after birth

  2. gestational age

    Time frame: up to 10 weeks (until term age - discharge)

    term and preterm neonates

Other outcomes

  1. TOI

    Time frame: 5 minutes (duration of 5 re-applications)

    cTOI, pTOI

  2. routine monitoring data - arterial oxygen saturation (SpO2)

    Time frame: up to 10 weeks (until term age - discharge)

    SpO2 in percentage (%)

  3. routine monitoring data - heart rate (HR)

    Time frame: up to 10 weeks (until term age - discharge)

    HR im beats per minute (bpm)

  4. routine monitoring data - blood pressure (RR)

    Time frame: up to 10 weeks (until term age - discharge)

    RR in mmHg

  5. routine monitoring data (temperature)

    Time frame: up to 10 weeks (until term age - discharge)

    temperature in °C

  6. Laboratory parameter

    Time frame: up to 10 weeks (until term age - discharge)

    C reactive protein (mg/l) - routinely sampled

  7. Laboratory parameter

    Time frame: up to 10 weeks (until term age - discharge)

    leukocytes (per µl) - routinely sampled

  8. Laboratory parameter

    Time frame: up to 10 weeks (until term age - discharge)

    IT-ratio - routinely sampled

  9. Laboratory parameter

    Time frame: up to 10 weeks (until term age - discharge)

    blood cultures - routinely sampled

  10. Demographic data of the neonate

    Time frame: up to 10 weeks (until term age - discharge)

    gestational age (weeks)

  11. Demographic data of the neonate

    Time frame: up to 10 weeks (until term age - discharge)

    birth weight (grams)

  12. Demographic data of the neonate

    Time frame: up to 10 weeks (until term age - discharge)

    risk factors

  13. Data of the neonate

    Time frame: up to 10 weeks (until term age - discharge)

    diagnosis (descriptive)

  14. Data of the neonate

    Time frame: up to 10 weeks (until term age - discharge)

    therapy (descriptive)

  15. Medication

    Time frame: up to 10 weeks (until term age - discharge)

    medication in appropriate dosage

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Wolfsberger, MD

CONTACT

[email protected]

0043 316 385 81135

Gerhard Pichler, Prof., MD

CONTACT

[email protected]

0043 316 385 80520

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates - a Prospective Pilot Observational Study

Acronym: pFTOE

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 26, 2021
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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