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New study aims to uncover hidden risks of blood transfusions in preterm babies

NCT ID NCT07672275

Knowledge-focused Sponsor: Medical University of Graz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how blood transfusions affect tiny molecules called peroxides in very premature babies. These molecules can damage cells if they build up. Researchers will measure peroxide levels before and after transfusions, and also use a special light device to check oxygen in the brain. The goal is to understand these changes better and find ways to make transfusions safer for newborns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide reference values for oxidative stress in newborns and guide safer transfusion practices for preterm infants.
What could go wrong
This is a small, early observational pilot study. It does not test a treatment, so it cannot directly improve outcomes. Results may not apply to all hospitals or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

5 minutes to 5 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

beta thalassemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erythrocyte transfusion Fetal hemoglobin Near-infrared spectroscopy Oxidative stress in neonates

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Divison of Neonatology, Department of Pediatrics, Medical University of Graz

    RECRUITING

    Graz, Styria, 8036, Austria

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