Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates (pFTOE)

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

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

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Neonatal Infection

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 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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Gerhard Pichler, Prof., MD; Phone Number: 0043 316 385 80520; Email: gerhard.pichler@medunigraz.at
• Study Contact Backup: Name: Christina Wolfsberger, MD; Phone Number: 0043 316 385 81135; Email: christina.wolfsberger@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Department of Pediatrics, Division of Neonatology, Medical University of Graz
      • Contact: Gerhard Pichler, MD; Phone Number: 0043 316 385 80520; Email: gerhard.pichler@medunigraz.at
      • Principal Investigator: Gerhard Pichler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 hours (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Term and preterm neonates ≥30+0 weeks of gestation with respiratory distress and risk factors for infection admitted to the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz after vaginal delivery or caesarean section on the first day after birth will be eligible for the study.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Preterm neonates with infection; Preterm neonates (30+0 - 36+6 weeks of gestation) with clinical and laboratory signs of early onset infection (within 72 hours after birth).
Preterm neonates without infection; Preterm neonates (30+0 - 36+6 weeks of gestation) without clinical and laboratory signs of early onset infection (within 72 hours after birth).
Term neonates with infection; Preterm neonates (30+0 - 36+6 weeks of gestation) with clinical and laboratory signs of early onset infection (within 72 hours after birth).
Term neonates without infection; Preterm neonates (30+0 - 36+6 weeks of gestation) without clinical and laboratory signs of early onset infection (within 72 hours after birth).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pFTOE	pFTOE within 6 hours after birth	5 minutes (duration of 5 re-applications)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cFTOE	cFTOE and cFTOE/pFTOE within 6 hours after birth	5 minutes (duration of 5 re-applications)
gestational age	term and preterm neonates	up to 10 weeks (until term age - discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TOI	cTOI, pTOI	5 minutes (duration of 5 re-applications)
routine monitoring data - arterial oxygen saturation (SpO2)	SpO2 in percentage (%)	up to 10 weeks (until term age - discharge)
routine monitoring data - heart rate (HR)	HR im beats per minute (bpm)	up to 10 weeks (until term age - discharge)
routine monitoring data - blood pressure (RR)	RR in mmHg	up to 10 weeks (until term age - discharge)
routine monitoring data (temperature)	temperature in °C	up to 10 weeks (until term age - discharge)
Laboratory parameter	C reactive protein (mg/l) - routinely sampled	up to 10 weeks (until term age - discharge)
Laboratory parameter	leukocytes (per µl) - routinely sampled	up to 10 weeks (until term age - discharge)
Laboratory parameter	IT-ratio - routinely sampled	up to 10 weeks (until term age - discharge)
Laboratory parameter	blood cultures - routinely sampled	up to 10 weeks (until term age - discharge)
Demographic data of the neonate	gestational age (weeks)	up to 10 weeks (until term age - discharge)
Demographic data of the neonate	birth weight (grams)	up to 10 weeks (until term age - discharge)
Demographic data of the neonate	risk factors	up to 10 weeks (until term age - discharge)
Data of the neonate	diagnosis (descriptive)	up to 10 weeks (until term age - discharge)
Data of the neonate	therapy (descriptive)	up to 10 weeks (until term age - discharge)
Medication	medication in appropriate dosage	up to 10 weeks (until term age - discharge)

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Gerhard Pichler, Prof., MD, Medical University of Graz, Department of Pediatric and Adolescent Medicine, Division of Neonatology

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Infections; Communicable Diseases
• Other Study ID Numbers: pFTOE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No