Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trial.
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Teofili Luciana, Papacci Patrizia, Pellegrino Claudio, Dani Carlo, Cresi Francesco, Remaschi Giulia, Ansaldi Giulia, Giannantonio Carmen, Campagnoli Maria Francesca, Vania Barbara, Fabbri Marco, de Vera d' Aragona Roberta Penta, Molisso Anna, Beccastrini Enrico, Dragonetti Antonella, Pasciuto Tina, Gabbriellini Sabrina, Baroni Silvia, Serrao Francesca, Purcaro Velia, Raffaeli Genny, Villa Stefania, Prati Daniele, Mondello Isabella, Falcone Alessandra, Patti Maria Letizia, Boggini Tiziana, Bergamaschi Paola, Lepore Domenico, Franco Fabrizio Gaetano Saverio, Orazi Lorenzo, Mozzetta Iolanda, Baldascino Antonio, Valentini Caterina Giovanna, Locatelli Emanuela, Albiani Roberto, Besso Federico Genzano, Cantone Giulia Vanina, Coscia Alessandra, Trimarchi Alfonso, Cavallaro Giacomo, Ghirardello Stefano, Vento Giovanni
Аннотация
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).