EClinicalMedicine (Sep 2025)
Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in context
- Luciana Teofili,
- Patrizia Papacci,
- Claudio 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,
- Sabrina 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 Gaetano Saverio 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
Affiliations
- Luciana Teofili
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy; Corresponding author. Emotrasfusione, Fondazione Policlinico A. Gemelli IRCCS, Largo Gemelli 8, Rome, 00168, Italy.
- Patrizia Papacci
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
- Claudio Pellegrino
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
- Carlo Dani
- Azienda Ospedaliero Universitaria Careggi, Firenze, Italy
- Francesco Cresi
- Città della Salute e della Scienza, Torino, Italy; Department of Public Health and Pediatrics, Università di Torino, Torino, Italy
- Giulia Remaschi
- Azienda Ospedaliero Universitaria Careggi, Firenze, Italy
- Giulia Ansaldi
- Città della Salute e della Scienza, Torino, Italy
- Carmen Giannantonio
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy
- Maria Francesca Campagnoli
- Città della Salute e della Scienza, Torino, Italy
- Barbara Vania
- Città della Salute e della Scienza, Torino, Italy
- Marco Fabbri
- Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
- Roberta Penta de Vera d' Aragona
- Ospedale Santobono Pausilipon, Napoli, Italy
- Anna Molisso
- Ospedale Evangelico Villa Betania, Napoli, Italy
- Enrico Beccastrini
- Azienda Ospedaliero Universitaria Careggi, Firenze, Italy
- Antonella Dragonetti
- Città della Salute e della Scienza, Torino, Italy
- Tina Pasciuto
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
- Sabrina Gabbriellini
- Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
- Silvia Baroni
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
- Francesca Serrao
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy
- Velia Purcaro
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy
- Genny Raffaeli
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; Department of Clinical Sciences and Community Health, Università di Milano, Italy
- Stefania Villa
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
- Daniele Prati
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; Department of Clinical Sciences and Community Health, Università di Milano, Italy
- Isabella Mondello
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy
- Alessandra Falcone
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy
- Maria Letizia Patti
- Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy
- Tiziana Boggini
- Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy
- Paola Bergamaschi
- Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy
- Domenico Lepore
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
- Fabrizio Gaetano Saverio Franco
- Azienda Ospedaliero Universitaria Careggi, Firenze, Italy
- Lorenzo Orazi
- Polo Nazionale Ipovisione IAPB Italia Onlus, Rome, Italy
- Iolanda Mozzetta
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy
- Antonio Baldascino
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy
- Caterina Giovanna Valentini
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy
- Emanuela Locatelli
- Città della Salute e della Scienza, Torino, Italy
- Roberto Albiani
- Città della Salute e della Scienza, Torino, Italy
- Federico Genzano Besso
- Città della Salute e della Scienza, Torino, Italy
- Giulia Vanina Cantone
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy
- Alessandra Coscia
- Città della Salute e della Scienza, Torino, Italy; Department of Public Health and Pediatrics, Università di Torino, Torino, Italy
- Alfonso Trimarchi
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy
- Giacomo Cavallaro
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
- Stefano Ghirardello
- Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy
- Giovanni Vento
- Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
- DOI
- https://doi.org/10.1016/j.eclinm.2025.103426
- Journal volume & issue
-
Vol. 87
p. 103426
Abstract
Summary: 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).
Keywords
- Extremely low gestational age neonates
- Retinopathy of prematurity
- Transfusions
- Fetal hemoglobin
- Umbilical blood
- Randomized controlled trial
