Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-31
SponsorUniversity of Parma

About this trial

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

Eligibility criteria

Qualifiers

Preterm neonates born between 24+0 and 31+6 weeks of gestational age;

Requirement for at least one red blood cell transfusion during hospitalization, according to current Italian transfusion thresholds;

Written informed consent obtained from parents or legal guardians prior to any study procedure.

Disqualifiers

Gestational age > 32+0 weeks;

Pregnancy complicated by maternal-fetal alloimmunization (e.g., hemolytic disease of the newborn);

Pregnancy complicated by fetal hydrops;

Major congenital anomalies or genetic syndromes;

Trial design

Treatments tested in this trial

  • Cord Blood Red Blood Cell Transfusion (CB-RBC)
  • Adult Donor Red Blood Cell Transfusion (A-RBC)

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators