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

23. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

170

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Österreich
    • Styria
      • Graz, Styria, Österreich, 8036
        • Rekrutierung
        • Divison of Neonatology, Department of Pediatrics, Medical University of Graz
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Ena Suppan, MD
        • Unterermittler:
          • Gerhard Cvirn, Associate Professor, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Diagnosetest: 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.
Diagnosetest: 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.
Diagnosetest: 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.
Gerät: 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.
Andere Namen:
  • t-NIRS

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peroxide levels- Part A
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Medical University of Graz

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Dezember 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

1. Februar 2028

Studienanmeldedaten

Zuerst eingereicht

15. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1319/2025

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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