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

NCT04818762 | Recruiting

• 1 other identifier: pFTOE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal Infection; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• pFTOE

  pFTOE within 6 hours after birth

  5 minutes (duration of 5 re-applications)

Secondary Outcomes (2)

• cFTOE

  5 minutes (duration of 5 re-applications)

• gestational age

  up to 10 weeks (until term age - discharge)

Other Outcomes (15)

• TOI

  5 minutes (duration of 5 re-applications)

• routine monitoring data - arterial oxygen saturation (SpO2)

  up to 10 weeks (until term age - discharge)

• routine monitoring data - heart rate (HR)

  up to 10 weeks (until term age - discharge)

Study Arms (4)

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).

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Decision to conduct full life support
• Written informed consent
• Age \< 6 hours

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

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

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gerhard Pichler, Prof., MD

  Medical University of Graz, Department of Pediatric and Adolescent Medicine, Division of Neonatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard Pichler, Prof., MD

CONTACT

0043 316 385 80520; gerhard.pichler@medunigraz.at

Christina Wolfsberger, MD

CONTACT

0043 316 385 81135; christina.wolfsberger@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 26, 2021
• Study Start: February 26, 2021
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)