umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN) - Trial NCT05100212

Timeline & Enrollment

Primary Outcome

Retinopathy of prematurity

Summary

Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are
 among the most heavily transfused pediatric patients. In this clinical setting, repeated red
 blood cell (RBC) transfusions independently predict a poor outcome, with a higher risk for
 mortality and morbidity. Recent studies from our own and other groups highlighted a close
 association between low levels of fetal hemoglobin (HbF) and severity of retinopathy of
 prematurity (ROP) and bronchopulmonary dysplasia (BPD), two disabilities that frequently
 complicate preterm birth. This association is not surprising, considering that 1) preterm
 neonates have a highly immature antioxidant reserve and both ROP and BPD rely on the
 oxidative damage as underlying mechanism; 2) in comparison with HbA, HbF is endowed with
 higher oxygen affinity, greater redox potential, higher tetrameric stability, and higher
 ability to generate unbound nitric oxide, all functions potentially protective in presence of
 an oxidative challenge; 3) in normal prenatal life, developing organ and tissues are exposed
 exclusively to HbF until last weeks of gestation; 4) in preterm neonates, the switch of the
 synthesis from HbF to HbA occurs around their due date, i.e., several weeks after the
 premature birth; 5) when preterm neonates receive transfusions, their tissues are abruptly
 exposed to high levels of HbA. We have recently run a pilot trial demonstrating as a
 proof-of-concept that transfusing cord blood red blood cell concentrates (CB-RBC) effectively
 prevents or restrains the HbF loss consequent to adult donor standard transfusions (A-RBC).
 This study explores the hypothesis that transfusing CB-RBCs instead of A-RBC may lower the
 incidence of severe ROP in ELGANs needing transfusions.

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