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Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood

NCT07636473 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-11

No results posted yet for this study

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

Conditions

  • Prematurity Complications
  • Anemia

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.

Sponsors & Collaborators

  • University of Parma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
24 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2028-01-01
Completion
2029-11-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07636473 on ClinicalTrials.gov