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Transfusion-Related Changes in Oxidative Stress Biomarkers in Neonates (NEO-REDOX)

23. června 2026 aktualizováno: Medical University of Graz

Transfusion-Related Changes in Oxidative Stress Biomarkers in Neonates - a Three-Part Prospective Observational Pilot Study

Reactive oxygen species (ROS), which include peroxides, are generated in the human body as by-products of cellular metabolism. In small amounts, they fulfill important physiological functions. However, when produced in excess, they can damage cells and tissues. Extremely low gestation age neonates (ELGANs) are particularly vulnerable to such harmful effects because their antioxidant defense systems are immature, and they are exposed to increased ROS levels due to the oxygen therapy required after birth.

Fetal hemoglobin (HbF), the primary oxygen carrier in the blood of newborns, plays a crucial role in this context. Compared with adult hemoglobin (HbA), it has a higher oxygen affinity and a more pronounced pseudoperoxidase activity, which helps protect organs during early development from peroxides.

In addition to oxygen administration, blood transfusions can also contribute to increased ROS formation. Due to the immature hematopoietic system and the diagnostic blood sampling required, ELGANs frequently receive transfusions with adult red blood cell (A-RBC) concentrates. These lead to a rapid shift from HbF to HbA, further promoting the generation of ROS.

Measuring ROS in blood is particularly challenging because these molecules are extremely short-lived. Consequently, reference values for newborns are lacking. Therefore, the investigators aim to establish reference ranges for one ROS, the peroxide in both term and preterm healty neonates from birth event onward and to assess the effects of A-RBC transfusions on this parameter in ELGANs.

Furthermore, combining near-infrared spectroscopy-derived measurements of cerebral regional tissue oxygenation with peroxide assessments requiring only minimal blood volumes (0.5 mL per sample) will provide a more comprehensive and quantitatively robust understanding of the physiological changes induced by A-RBC transfusions in ELGANs.

Excessive ROS exposure is considered a key risk factor for severe complications of prematurity, including brain injury, retinopathy, and chronic lung disease. With this project, investigators aim to improve the understanding of these risks and promote new evidence-based strategies in transfusion medicine. In the long term, transfusions with HbF-rich red blood cells derived from cord blood could help reduce ROS formation and provide effective protection for particularly vulnerable preterm infants.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

170

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Rakousko
    • Styria
      • Graz, Styria, Rakousko, 8036
        • Nábor
        • Divison of Neonatology, Department of Pediatrics, Medical University of Graz
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Ena Suppan, MD
        • Dílčí vyšetřovatel:
          • Gerhard Cvirn, Associate Professor, PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Part A: All neonates routinely monitored immediately after birth at the Division of Neonatology, Department of Pediatrics, Medical University of Graz, will be eligible for peroxide measurements from umbilical cord blood to establish baseline values.

Part B: Preterm and term neonates (>=37+0 weeks ́gestation) admitted to the NICU for medical treatment without RBC transfusions, will be included in the study of time-dependent changes in peroxide levels.

Part C: ELGANs (22+5-27+6 weeks ́gestation) will be included in the study on the effects of RBC transfusions on changes in peroxide levels.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Part A: healthy preterm and term neonates
All neonates routinely monitored immediately after birth at the Division of Neonatology, Department of Pediatrics, Medical University of Graz, will be eligible for peroxide measurements from umbilical cord blood to establish baseline values.
Diagnostický test: Peroxide analysis-TOC Omnignostica Forschungs GmbH
1. Freshly prepared serum or EDTA plasma samples (total volume 0.5 ml) stored at room temperature for no longer than 30 minutes will be used for the peroxide analysis (TOC Omnignostica Forschungs GmbH, Höflein/Danube, Austria). If an immediate testing is not possible, samples will be stored at -20 °C for a maximum of two weeks.
Part B: Preterm and term neonates admitted to the NICU
Preterm and term neonates admitted to the NICU for medical treatment without exposure to RBC transfusions, will be eligible for the measurement of time-dependent changes in peroxide levels.
Diagnostický test: Peroxide analysis-TOC Omnignostica Forschungs GmbH
1. Freshly prepared serum or EDTA plasma samples (total volume 0.5 ml) stored at room temperature for no longer than 30 minutes will be used for the peroxide analysis (TOC Omnignostica Forschungs GmbH, Höflein/Danube, Austria). If an immediate testing is not possible, samples will be stored at -20 °C for a maximum of two weeks.
Part C: Extremely low gestational age neonates <28+0 weeks gestation
ELGANs (22+5-27+6 weeks´gestation) will be included in the study on the effects of RBC transfusions on changes in peroxide levels alongside a NIRS measurement of changes in regional cerebral oxygenation before, during and after the transfusion.
Diagnostický test: Peroxide analysis-TOC Omnignostica Forschungs GmbH
1. Freshly prepared serum or EDTA plasma samples (total volume 0.5 ml) stored at room temperature for no longer than 30 minutes will be used for the peroxide analysis (TOC Omnignostica Forschungs GmbH, Höflein/Danube, Austria). If an immediate testing is not possible, samples will be stored at -20 °C for a maximum of two weeks.
Přístroj: Near Infrared Imaging
For NIRS measurements the t-NIRS 1 (Hamamatsu, Japan) will be used. This monitor uses a "continuous wave spatially resolved" technique and measures cerebral regional oxygen saturation (crSO2) non-invasively. A cerebral sensor will be placed and fixed with a CPAP cap on the left forehead. Duration of the transfusional measurement will be 8 hours (1h before, 6h during and 1h after the transfusion). Duration of post-transfusional measurement will be 1 hour and performed 12-24h and 6-8 days after the transfusion.
Ostatní jména:
  • t-NIRS

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Peroxide levels- Part A
Časové okno: Part A: From enrollment to the end of blood sampling from the placental part of the umbilical cord, at latest 30 minutes after birth.

Baseline peroxide levels in umbilical artery

Baseline peroxide levels in umbilical vein
Part A: From enrollment to the end of blood sampling from the placental part of the umbilical cord, at latest 30 minutes after birth.
Peroxide levels- Part B
Časové okno: Part B: From enrollment until one week (7 days) after the admission to the neonatal intensive care unit.
Peroxide levels at admission (<48h). Peroxide levels 48-72 h after admission. Peroxide levels 5-7 days after admission.
Part B: From enrollment until one week (7 days) after the admission to the neonatal intensive care unit.
Peroxide levels- Part C
Časové okno: Part C: From enrollment to the postmenstrual age of 40+0 weeks.

FHbF and HbFc in pre-transfusional and post-transfusional routinely sampled blood samples in ELGANs undergoing A-RBC transfusions up to 8 days after each transfusion.

Peroxide levels in pre-transfusional and post-transfusional blood samples, synchronized with routine blood draws in ELGANs undergoing A-RBC transfusions up to 8 days after each transfusion.

Cerebral NIRS measurement of the regional tissue oxygenation:

  1. Around an A-RBC transfusion: 1h before, 6h during and 1h after
  2. 12-24 hours after an A-RBC transfusion: over 1h
  3. 6-8 days following an A-RBC transfusion: over 1h
Part C: From enrollment to the postmenstrual age of 40+0 weeks.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Medical University of Graz

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ena Suppan, MD, Divison of Neonatology, Department of Pediatrics, Medical University of Graz, Auenbruggerplatz 32, 8036 Graz, Austria

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

12. prosince 2025

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

1. února 2028

Termíny zápisu do studia

První předloženo

15. prosince 2025

První předloženo, které splnilo kritéria kontroly kvality

23. června 2026

První zveřejněno (Aktuální)

26. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1319/2025

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

The following individual participant data will be shared:

De-identified individual participant data underlying the results reported in the primary and secondary outcome analyses, including baseline demographic characteristics (e.g., age, sex), eligibility variables, group assignment, outcome measures, and key covariates used in the statistical analyses.

The following data will not be shared:

Direct identifiers (e.g., names, addresses), free-text clinical notes, imaging files, genetic data, and any data that could reasonably lead to re-identification of participants.

Časový rámec sdílení IPD

IPD and supporting information will be available beginning 6 months after publication of the primary results and ending 5 years after publication.

Kritéria přístupu pro sdílení IPD

De-identified individual participant data underlying the published results may be shared with qualified researchers upon reasonable request, subject to approval by the study investigators and execution of a data-sharing agreement.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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