Does early red blood cell transfusion affect complications and neurodevelopment in premature infants?
Official title: The Correlation Between Packed Red Blood Cell Transfusion and Early and Late Complications of Prematurity
Run by Clinical Hospital Center Rijeka · NCT07123948 · Data updated 2026-11-12
This study tests whether giving blood transfusions in the first month of life in premature babies is linked to early complications like ROP, NEC, BPD, IVH, and to later neurodevelopmental outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 7 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Clinical Hospital Center Rijeka Academic / other |
| Locations | 1 site (Rijeka, Primorje-Gorski Kotar County) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | March 1, 2029 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07123948 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Premature infants born before 32 weeks gestation who were treated at Clinical Hospital Centre Rijeka between June 2018 and December 2021 and are now six years old or turning six in 2025.
✕Probably not a fit
Infants born at term or those without exposure to early transfusions may not experience the studied associations.
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 uses retrospective data and prospective follow-up to examine associations between early erythrocyte transfusions and prematurity-related complications. It includes infants born <32 weeks from a single hospital and tracks outcomes up to age six, including a neurodevelopmental assessment with the Weschler Intelligence Test. The research aims to clarify potential links between transfusion exposure and adverse outcomes, acknowledging that evidence so far is mixed. No transfusion-guided intervention is being tested; the study observes existing practices and outcomes. The first phase analyzes historical data, while the second phase prospectively evaluates neurodevelopment at six years old.
Why it matters
Potential benefit: If a link is found, it could inform future transfusion practices to reduce risk of complications and support better long-term outcomes for preterm infants.
How similar studies have gone: Prior studies have reported conflicting findings; some show associations between transfusions and adverse outcomes, while others do not, making this study notably observational and context-specific.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * all children born as premature infants \<32. weeks of gestation in Clinical Hospital Centre Rijeka from June 2018. to December 2021. (and who will be on September 2025. six years old) * signed informed consent Exclusion Criteria: * genetic syndromes, severe congenital anomalies
Where it's running
-
Clinical Hospital Centre Rijeka, Department of Paediatrics
Rijeka, Primorje-Gorski Kotar County, Croatia Recruiting
Study contacts
- Principal investigator: senada šerifi — Clinical Hospital Centre Rijeka, Croatia
- Study coordinator: Kristina Lah Tomulić
- Email: kristina.lah.tomulic@medri.uniri.hr
- Phone: +385992015885
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Looking at tiny particles in cord blood of babies born before 28 weeks
The team will test whether extracellular vesicles in umbilical cord blood can help predict serious complications in babies born before 28 weeks of pregnancy.
-
Imaging retinal structure in premature babies to guide care
This study tests whether bedside ultra-widefield eye imaging can better guide treatment decisions for retinopathy of prematurity in preterm infants.
-
Delayed vs Immediate Umbilical Cord Clamping in Preterm Birth
This trial tests whether delaying the clamping of the umbilical cord after birth helps preterm babies more than clamping right away.
-
Enteral DHA and ARA Supplementation for Very Preterm Infants with BPD Risk
This study tests whether giving a specific mix of DHA and ARA through feeding helps prevent bronchopulmonary dysplasia in extremely and very preterm babies.
-
Continuing CPAP protection for extremely preterm babies to reduce BPD or death
This study tests whether keeping CPAP up to 34 weeks' PMA or for at least 2 more weeks, instead of weaning to a nasal cannula, lowers the chance of bronchopulmonary dysplasia or death by 36 weeks' PMA in babies born before 29 weeks gestation.
-
Long-term impact of BPD on parents and caregivers (BronQ Family)
This project will see how having a child who had bronchopulmonary dysplasia (BPD) affects parents' and caregivers' quality of life and family burden across several countries using an online questionnaire.
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.