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NOT YET RECRUITING
NCT07636473
NA

Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood

Sponsor: University of Parma

View on ClinicalTrials.gov

Summary

Long-term morbidities among very low birth weight infants remain a significant challenge. Oxidative stress is a key factor in the pathogenesis of 'free radical (FR) diseases of prematurity,' including retinopathy of prematurity, bronchopulmonary dysplasia, necrotizing enterocolitis, and intraventricular hemorrhage. Red blood cell (RBC) transfusions are recognized as a contributing factor to FR-related diseases. RBCs contain adult hemoglobin (HbA), which has a lower affinity for oxygen. This characteristic increases oxygen delivery and tissue uptake, leading to a potentially harmful state of hyperoxia and over-generation of FRs. The strategy employs a multidisciplinary approach to evaluate the impact of cord blood transfusions in anemic newborns. Results will be assessed in relation to short- and long-term neonatal outcomes to determine the effectiveness of this new preventive strategy. Improving the current data are critical for setting action priorities for and monitoring progress

Official title: Advancing Neonatal Health: Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood

Key Details

Gender

All

Age Range

24 Weeks - 31 Weeks

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-11-01

Completion Date

2029-11-01

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Cord Blood Red Blood Cell Transfusion (CB-RBC)

Transfusion of leukodepleted, gamma-irradiated cord blood-derived red blood cell concentrates (CB-RBC), prepared from donated public cord blood bank units, characterized by high fetal hemoglobin (HbF) content and administered according to standard neonatal transfusion thresholds

OTHER

Adult Donor Red Blood Cell Transfusion (A-RBC)

Transfusion of leukodepleted, gamma-irradiated adult-donor derived red blood cell concentrates (A-RBC) administered according to standard neonatal transfusion thresholds.