Oxidative Stress in NeonatesNEO-REDOXNCT07672275
Transfusion-Related Changes in Oxidative Stress Biomarkers in Neonates
An observational study of Oxidative Stress in Neonates and Near Infrared Spectroscopy, run by Medical University of Graz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 minutes to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress in Neonates, Near Infrared Spectroscopy, Fetal Hemoglobin
- What is being tested?
- Peroxide analysis-TOC Omnignostica Forschungs GmbH and Near Infrared Imaging
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteAustria
- Study dates
- 12 Dec 2025to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 minutes to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Divison of Neonatology, Department of Pediatrics, Medical University of Graz
Graz, Styria, 8036
Ena Suppan, MD, +43 676 645 90 70, ena.suppan@medunigraz.at
Gerhard Pichler, University Professor, MD, + 43-316-385-80520, gerhard.pichler@medunigraz.at
About this study
Official title: 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.
Read more
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.
- Conditions
- Oxidative Stress in Neonates, Near Infrared Spectroscopy, Fetal Hemoglobin, Erythrocyte Transfusion
- Being tested
- Peroxide analysis-TOC Omnignostica Forschungs GmbH, Near Infrared Imaging
- Keywords
- fetal hemoglobin, erythrocyte transfusion, preterm neonates, peroxide, oxidative stress
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroxide analysis-TOC Omnignostica Forschungs GmbHDiagnostic test
- 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.
Near Infrared ImagingDevice
Also called t-NIRS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Peroxide analysis-TOC Omnignostica Forschungs GmbH | |
| 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. Receives: Diagnostic Test: Peroxide analysis-TOC Omnignostica Forschungs GmbH | |
| 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. Receives: Diagnostic Test: Peroxide analysis-TOC Omnignostica Forschungs GmbH; Device: Near Infrared Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroxide levels- Part A
Baseline peroxide levels in umbilical artery
Baseline peroxide levels in umbilical vein
Measured: 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
Peroxide levels at admission (<48h). Peroxide levels 48-72 h after admission. Peroxide levels 5-7 days after admission.
Measured: Part B: From enrollment until one week (7 days) after the admission to the neonatal intensive care unit.
Peroxide levels- Part C
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:
- Around an A-RBC transfusion: 1h before, 6h during and 1h after
- 12-24 hours after an A-RBC transfusion: over 1h
- 6-8 days following an A-RBC transfusion: over 1h
Measured: Part C: From enrollment to the postmenstrual age of 40+0 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start12 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative Stress in NeonatesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ena Suppan, MD, Principal investigator, Divison of Neonatology, Department of Pediatrics, Medical University of Graz, Auenbruggerplatz 32, 8036 Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672275
- Sponsor's protocol ID
- 1319/2025
- Acronym
- NEO-REDOX
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion-Related Changes in Oxidative Stress Biomarkers in Neonates - a Three-Part Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT07672275
- Acronym / sponsor ID
- NEO-REDOX / 1319/2025
- Conditions
- Oxidative Stress in Neonates, Near Infrared Spectroscopy, Fetal Hemoglobin, Erythrocyte Transfusion
- Keywords
- fetal hemoglobin, erythrocyte transfusion, preterm neonates, peroxide, oxidative stress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: healthy preterm and term neonates | – | Diagnostic Test: Peroxide analysis-TOC Omnignostica Forschungs GmbHAll 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 admitted to the NICU | – | Diagnostic Test: Peroxide analysis-TOC Omnignostica Forschungs GmbHPreterm 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. |
| Part C: Extremely low gestational age neonates <28+0 weeks gestation | – | Diagnostic Test: Peroxide analysis-TOC Omnignostica Forschungs GmbH, Device: Near Infrared ImagingELGANs (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. |
Who may qualify
- Ages
- 5 minutes to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (11 listed)
- Neonates who are monitored on the NICU immediately after birth
- Written parental informed consent
- Term and preterm neonates admitted to the NICU for medical treatment
- Age ad admission <48 hours
- Written parental informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peroxide analysis-TOC Omnignostica Forschungs GmbH1. 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. | Diagnostic test | Part A: healthy preterm and term neonates, Part B: Preterm and term neonates admitted to the NICU, Part C: Extremely low gestational age neonates <28+0 weeks gestation |
| Near Infrared ImagingAlso: t-NIRSFor 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. | Device | Part C: Extremely low gestational age neonates <28+0 weeks gestation |
Primary outcome
Peroxide levels- Part A
Time frame: 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
Peroxide levels- Part B
Time frame: 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.
Peroxide levels- Part C
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ena Suppan, MD principal investigator
Divison of Neonatology, Department of Pediatrics, Medical University of Graz, Auenbruggerplatz 32, 8036 Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress in Neonates and Near Infrared Spectroscopy, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ena Suppan, MD (+4331638581477; +436766459070, ena.suppan@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peroxide levels- Part A (time frame: Part A: From enrollment to the end of blood sampling from the placental part of the umbilical cord, at latest 30 minutes after birth.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.