Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trial
Luciana Teofili, Patrizia Papacci, C Pellegrino, Carlo Dani, Francesco Cresi, Giulia Remaschi, Giulia Ansaldi, Carmen Giannantonio, Maria Francesca Campagnoli, Barbara Vania, Marco Fabbri, Roberta Penta de Vera d’ Aragona, Anna Molisso, Enrico Beccastrini, Antonella Dragonetti, Tina Pasciuto, S Gabbriellini, Silvia Baroni, Francesca Serrao, Velia Purcaro, Genny Raffaeli, Stefania Villa, Daniele Prati, Isabella Mondello, Alessandra Falcone, Maria Letizia Patti, Tiziana Boggini, Paola Bergamaschi, Domenico Lepore, Fabrizio Franco, Lorenzo Orazi, Iolanda Mozzetta, Antonio Baldascino, Caterina Giovanna Valentini, Emanuela Locatelli, Roberto Albiani, Federico Genzano Besso, Giulia Vanina Cantone, Alessandra Coscia, Alfonso Trimarchi, Giacomo Cavallaro, Stefano Ghirardello, Giovanni Vento
Abstract
Background Red blood cell (RBC) transfusions in preterm neonates are associated with retinopathy of prematurity (ROP). Methods BORN is a multicenter randomized trial investigating whether RBC transfusions from cord blood (CB-RBCs) instead of adult donors (A-RBCs) reduce ROP severity (NCT05100212). The study was conducted between December 2021 and November 2024 in 8 hospitals sited in 8 different Italian regions. Extremely low gestational age neonates (ELGANs) were randomized 1:1 to receive A-RBCs (control) or CB-RBCs (intervention) from birth to postmenstrual age (PMA) of 29 + 6 weeks. The main outcome was severe-ROP rate at 40 weeks PMA or discharge. Findings By intention-to-treat-analysis, 56 patients per arm were evaluated: 16 in the control arm and 14 in the intervention arm developed severe ROP (28·6% versus 25·0%, risk difference [RD] −0·03 [95% CI −0·21% to 0·14%]; P = 0·831). Twenty-four (42·8%) patients in the intervention arm received also A-RBCs. Per-protocol-analysis included those patients receiving exclusively the assigned treatment, consisting of 38 ELGANs in the control arm and 17 in the intervention arm, with comparable characteristics. Thirteen ELGANs in the control arm developed severe ROP, and 10 required ROP treatment whilst no patients in the intervention arm developed severe ROP or treatment-requiring ROP (34·2% versus 0%, RD −0·34 [95% CI −0·51% to −0·07%] for severe ROP, P = 0·005, and 26·3% versus 0%, RD −0·28 [95% CI −0·46% to −0·02%] for treatment-requiring ROP, P = 0·022). Twenty-four patients in the control arm and 5 in the intervention arm developed moderate/severe BPD (63·2% versus 29·4%, RD −0·33 [95% CI −0·56% to −0·02%], P = 0·039). Interpretation CB-RBCs may protect ELGANs from severe forms of ROP and BPD. Funding Funded by Fresenius HemoCare Italia SRL (Prot. N 0038762/21-04/11/2021; grant number 5800134-FPG).