TY - JOUR
T1 - BORN study
T2 - a multicenter randomized trial investigating cord blood red blood cell transfusions to reduce the severity of retinopathy of prematurity in extremely low gestational age neonates
AU - Teofili, Luciana
AU - Papacci, Patrizia
AU - Orlando, Nicoletta
AU - Bianchi, Maria
AU - Pasciuto, Tina
AU - Mozzetta, Iolanda
AU - Palluzzi, Fernando
AU - Giacò, Luciano
AU - Giannantonio, Carmen
AU - Remaschi, Giulia
AU - Santosuosso, Michela
AU - Beccastrini, Enrico
AU - Fabbri, Marco
AU - Valentini, Caterina Giovanna
AU - Bonfini, Tiziana
AU - Cloclite, Eleonora
AU - Accorsi, Patrizia
AU - Dragonetti, Antonella
AU - Cresi, Francesco
AU - Ansaldi, Giulia
AU - Raffaeli, Genny
AU - Villa, Stefania
AU - Pucci, Giulia
AU - Mondello, Isabella
AU - Santodirocco, Michele
AU - Ghirardello, Stefano
AU - Vento, Giovanni
N1 - Funding Information:
BORN has been supported by Fresenius HemoCare. Fresenius HemoCare provided cell separators and consumables necessary for the manufacture of cord blood transfusions. Fresenius HemoCare has no role in the design of the study; in the collection, analysis, and interpretation of the data; and in writing the manuscript.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: Extremely low gestational age neonates (ELGANs, i.e., neonates born before 28 weeks of gestation) are at high risk of developing retinopathy of prematurity (ROP), with potential long-life visual impairment. Due to concomitant anemia, ELGANs need repeated red blood cell (RBC) transfusions. These produce a progressive replacement of fetal hemoglobin (HbF) by adult hemoglobin (HbA). Furthermore, a close association exists between low levels of HbF and severe ROP, suggesting that a perturbation of the HbF-mediated oxygen release may derange retinal angiogenesis and promote ROP. Methods/design: BORN (umBilical blOod to tRansfuse preterm Neonates) is a multicenter double-blinded randomized controlled trial in ELGANs, to assess the effect of allogeneic cord blood RBC transfusions (CB-RBCs) on severe ROP development. Recruitment, consent, and randomization take place at 10 neonatology intensive care units (NICUs) of 8 Italian tertiary hospitals. ELGANs with gestational age at birth comprised between 24+0 and 27+6 weeks are randomly allocated into two groups: (1) standard RBC transfusions (adult-RBCs) (control arm) and (2) CB-RBCs (intervention arm). In case of transfusion need, enrolled patients receive transfusions according to the allocation arm, unless an ABO/RhD CB-RBC is unavailable. Nine Italian public CB banks cooperate to make available a suitable amount of CB-RBC units for all participating NICUs. The primary outcome is the incidence of severe ROP (stage 3 or higher) at discharge or 40 weeks of postmenstrual age, which occurs first. Discussion: BORN is a groundbreaking trial, pioneering a new transfusion approach dedicated to ELGANs at high risk for severe ROP. In previous non-randomized trials, this transfusion approach was proven feasible and able to prevent the HbF decrease in patients requiring multiple transfusions. Should the BORN trial confirm the efficacy of CB-RBCs in reducing ROP severity, this transfusion strategy would become the preferential blood product to be used in severely preterm neonates. Trial registration: ClinicalTrials.gov NCT05100212.
AB - Background: Extremely low gestational age neonates (ELGANs, i.e., neonates born before 28 weeks of gestation) are at high risk of developing retinopathy of prematurity (ROP), with potential long-life visual impairment. Due to concomitant anemia, ELGANs need repeated red blood cell (RBC) transfusions. These produce a progressive replacement of fetal hemoglobin (HbF) by adult hemoglobin (HbA). Furthermore, a close association exists between low levels of HbF and severe ROP, suggesting that a perturbation of the HbF-mediated oxygen release may derange retinal angiogenesis and promote ROP. Methods/design: BORN (umBilical blOod to tRansfuse preterm Neonates) is a multicenter double-blinded randomized controlled trial in ELGANs, to assess the effect of allogeneic cord blood RBC transfusions (CB-RBCs) on severe ROP development. Recruitment, consent, and randomization take place at 10 neonatology intensive care units (NICUs) of 8 Italian tertiary hospitals. ELGANs with gestational age at birth comprised between 24+0 and 27+6 weeks are randomly allocated into two groups: (1) standard RBC transfusions (adult-RBCs) (control arm) and (2) CB-RBCs (intervention arm). In case of transfusion need, enrolled patients receive transfusions according to the allocation arm, unless an ABO/RhD CB-RBC is unavailable. Nine Italian public CB banks cooperate to make available a suitable amount of CB-RBC units for all participating NICUs. The primary outcome is the incidence of severe ROP (stage 3 or higher) at discharge or 40 weeks of postmenstrual age, which occurs first. Discussion: BORN is a groundbreaking trial, pioneering a new transfusion approach dedicated to ELGANs at high risk for severe ROP. In previous non-randomized trials, this transfusion approach was proven feasible and able to prevent the HbF decrease in patients requiring multiple transfusions. Should the BORN trial confirm the efficacy of CB-RBCs in reducing ROP severity, this transfusion strategy would become the preferential blood product to be used in severely preterm neonates. Trial registration: ClinicalTrials.gov NCT05100212.
KW - Extremely low gestational age neonates
KW - Fetal hemoglobin
KW - Randomized controlled trial
KW - Retinopathy of prematurity
KW - Transfusions
KW - Umbilical blood
UR - http://www.scopus.com/inward/record.url?scp=85144154039&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85144154039&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06949-8
DO - 10.1186/s13063-022-06949-8
M3 - Article
C2 - 36514106
AN - SCOPUS:85144154039
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 1010
ER -