Transfusion-Related Changes in Oxidative Stress Markers in Newborns
Official title: Transfusion-Related Changes in Oxidative Stress Biomarkers in Neonates - a Three-Part Prospective Observational Pilot Study
Run by Medical University of Graz · NCT07672275 · Data updated 2026-11-12
This study tests whether red blood cell transfusions and oxygen therapy affect oxidative stress markers in newborns, especially extremely preterm babies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Minutes to 5 Months |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Status | Recruiting |
| Started | December 12, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | February 1, 2028 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07672275 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
ELGANs (22+5 to 27+6 weeks gestation) and other NICU neonates whose families provide informed consent and where full life-support decisions are in place.
✕Probably not a fit
Patients without full life-support decisions or without consent, or those with congenital malformations or fetal hemoglobinopathies, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines how transfused red blood cells and oxygen exposure influence oxidative stress biomarkers in neonates. It includes multiple parts: infants monitored in the NICU at birth, other NICU-admitted neonates, and extremely preterm infants (22+5 to 27+6 weeks) requiring full life-support decisions. Peroxide analyses are performed using TOC Omnignostica technologies and near-infrared imaging to explore ROS dynamics. The study leverages parental informed consent and excludes cases with congenital malformations, fetal anemia requiring in-utero transfusion, and lack of life-support decisions. Lead sponsorship is by the Medical University of Graz with no listed collaborators and is conducted at the Graz neonatology division.
Why it matters
Potential benefit: Findings could help refine transfusion practices and oxygen therapy to minimize oxidative stress in vulnerable newborns.
How similar studies have gone: Previous work has shown oxidative stress markers can be influenced by transfusion and oxygen exposure in neonates, though this exact approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Part A: * Neonates who are monitored on the NICU immediately after birth * Written parental informed consent Part B: * Term and preterm neonates admitted to the NICU for medical treatment * Age ad admission \<48 hours * Written parental informed consent Part C: * ELGANs 22(+5)-27(+6) weeks (days) gestation admitted to the NICU * Decision to conduct full life support * Written parental informed consent Exclusion criteria (Part A, B, C) * No decision to conduct full life support * No parental written informed consent * Congenital malformations * Family history of hemoglobinopathies (e.g. sickle cell anemia, thalassemia) * Fetal anemia requiring in-utero A-RBC transfusions
Where it's running
-
Divison of Neonatology, Department of Pediatrics, Medical University of Graz
Graz, Styria, Austria Recruiting
Study contacts
- Principal investigator: Ena Suppan, MD — Divison of Neonatology, Department of Pediatrics, Medical University of Graz, Auenbruggerplatz 32, 8036 Graz, Austria
- Study coordinator: Ena Suppan, MD
- Email: ena.suppan@medunigraz.at
- Phone: +4331638581477; +436766459070
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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.