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

  • STATUS
    Recruiting
  • End date
    Dec 12, 2023
  • participants needed
    146
  • sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Updated on 12 December 2021

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.

Details
Condition Retinopathy of Prematurity
Treatment cord blood-RBC concentrates, adult donor RBC concentrates
Clinical Study IdentifierNCT05100212
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Last Modified on12 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

gestational age (GA) at birth between 24+0 and 27+6 weeks
signed informed consent of parents

Exclusion Criteria

One or more of the following
maternal-fetal immunization
hydrops fetalis
major congenital malformations associated or not with genetic syndromes
previous transfusions
hemorrhage at birth
congenital infections
out-born infants
health care team deeming it inappropriate to approach the infant's family for informed consent
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