Measuring oxygen extraction in newborns with and without infections
Official title: Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates - a Prospective Pilot Observational Study
Run by Medical University of Graz · NCT04818762 · Data updated 2026-11-12
This study is trying to see if measuring oxygen levels in the blood can show differences between newborns with infections and those without, to help understand their breathing problems better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 6 Hours |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Status | Recruiting |
| Started | February 26, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | February 1, 2026 |
| Registry record updated | March 13, 2025 |
| Trial ID | NCT04818762 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are term and preterm neonates aged less than 6 hours with signs of respiratory distress and risk factors for infection.
✕Probably not a fit
Patients who are not undergoing full life support or have severe congenital malformations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational pilot study investigates the differences in peripheral fractional tissue oxygen extraction (pFTOE) in term and preterm neonates with respiratory distress, comparing those with early onset infections to those without. Using near-infrared spectroscopy (NIRS), the study aims to monitor oxygenation and perfusion non-invasively within the first six hours after birth. The primary objective is to determine if pFTOE measurements differ between the two groups, while secondary objectives include assessing cerebral fractional tissue oxygen extraction (cFTOE) and the relationship between cFTOE and pFTOE. The study population includes neonates at risk for infection admitted to the neonatal intensive care unit (NICU).
Why it matters
Potential benefit: If successful, this study could enhance early detection of infections in newborns, potentially improving treatment outcomes.
How similar studies have gone: While the use of NIRS for monitoring oxygenation is established, this specific application in differentiating infection status in neonates is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Department of Pediatrics, Division of Neonatology, Medical University of Graz
Graz, Styria, Austria Recruiting
Study contacts
- Principal investigator: Gerhard Pichler, Prof., MD — Medical University of Graz, Department of Pediatric and Adolescent Medicine, Division of Neonatology
- Study coordinator: Gerhard Pichler, Prof., MD
- Email: gerhard.pichler@medunigraz.at
- Phone: 0043 316 385 80520
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.