Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in context
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 (NCT...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-09-01
|
| Series: | EClinicalMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S258953702500358X |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849237559333355520 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Luciana Teofili |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-b60dbe2111124a2b81ef89bb1d844f18 |
| institution | Kabale University |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj-art-b60dbe2111124a2b81ef89bb1d844f182025-08-20T04:01:56ZengElsevierEClinicalMedicine2589-53702025-09-018710342610.1016/j.eclinm.2025.103426Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in contextLuciana Teofili0Patrizia Papacci1Claudio Pellegrino2Carlo Dani3Francesco Cresi4Giulia Remaschi5Giulia Ansaldi6Carmen Giannantonio7Maria Francesca Campagnoli8Barbara Vania9Marco Fabbri10Roberta Penta de Vera d' Aragona11Anna Molisso12Enrico Beccastrini13Antonella Dragonetti14Tina Pasciuto15Sabrina Gabbriellini16Silvia Baroni17Francesca Serrao18Velia Purcaro19Genny Raffaeli20Stefania Villa21Daniele Prati22Isabella Mondello23Alessandra Falcone24Maria Letizia Patti25Tiziana Boggini26Paola Bergamaschi27Domenico Lepore28Fabrizio Gaetano Saverio Franco29Lorenzo Orazi30Iolanda Mozzetta31Antonio Baldascino32Caterina Giovanna Valentini33Emanuela Locatelli34Roberto Albiani35Federico Genzano Besso36Giulia Vanina Cantone37Alessandra Coscia38Alfonso Trimarchi39Giacomo Cavallaro40Stefano Ghirardello41Giovanni Vento42Fondazione 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.Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, ItalyAzienda Ospedaliero Universitaria Careggi, Firenze, ItalyCittà della Salute e della Scienza, Torino, Italy; Department of Public Health and Pediatrics, Università di Torino, Torino, ItalyAzienda Ospedaliero Universitaria Careggi, Firenze, ItalyCittà della Salute e della Scienza, Torino, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, ItalyCittà della Salute e della Scienza, Torino, ItalyCittà della Salute e della Scienza, Torino, ItalyAzienda Ospedaliero Universitaria Pisana, Pisa, ItalyOspedale Santobono Pausilipon, Napoli, ItalyOspedale Evangelico Villa Betania, Napoli, ItalyAzienda Ospedaliero Universitaria Careggi, Firenze, ItalyCittà della Salute e della Scienza, Torino, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, ItalyAzienda Ospedaliero Universitaria Pisana, Pisa, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, ItalyFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; Department of Clinical Sciences and Community Health, Università di Milano, ItalyFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, ItalyFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; Department of Clinical Sciences and Community Health, Università di Milano, ItalyGrande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, ItalyGrande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, ItalyFondazione IRCCS Policlinico S. Matteo, Pavia, ItalyFondazione IRCCS Policlinico S. Matteo, Pavia, ItalyFondazione IRCCS Policlinico S. Matteo, Pavia, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, ItalyAzienda Ospedaliero Universitaria Careggi, Firenze, ItalyPolo Nazionale Ipovisione IAPB Italia Onlus, Rome, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, ItalyCittà della Salute e della Scienza, Torino, ItalyCittà della Salute e della Scienza, Torino, ItalyCittà della Salute e della Scienza, Torino, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, ItalyCittà della Salute e della Scienza, Torino, Italy; Department of Public Health and Pediatrics, Università di Torino, Torino, ItalyGrande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, ItalyFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, ItalyFondazione IRCCS Policlinico S. Matteo, Pavia, ItalyFondazione Policlinico A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, ItalySummary: 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).http://www.sciencedirect.com/science/article/pii/S258953702500358XExtremely low gestational age neonatesRetinopathy of prematurityTransfusionsFetal hemoglobinUmbilical bloodRandomized controlled trial |
| spellingShingle | 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 Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in context EClinicalMedicine Extremely low gestational age neonates Retinopathy of prematurity Transfusions Fetal hemoglobin Umbilical blood Randomized controlled trial |
| title | Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in context |
| title_full | Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in context |
| title_fullStr | Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in context |
| title_full_unstemmed | Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in context |
| title_short | Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trialResearch in context |
| title_sort | cord red blood cell transfusions for severe retinopathy in preterm neonates in italy a multicenter randomized controlled trialresearch in context |
| topic | Extremely low gestational age neonates Retinopathy of prematurity Transfusions Fetal hemoglobin Umbilical blood Randomized controlled trial |
| url | http://www.sciencedirect.com/science/article/pii/S258953702500358X |
| work_keys_str_mv | AT lucianateofili cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT patriziapapacci cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT claudiopellegrino cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT carlodani cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT francescocresi cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT giuliaremaschi cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT giuliaansaldi cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT carmengiannantonio cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT mariafrancescacampagnoli cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT barbaravania cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT marcofabbri cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT robertapentadeveradaragona cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT annamolisso cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT enricobeccastrini cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT antonelladragonetti cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT tinapasciuto cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT sabrinagabbriellini cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT silviabaroni cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT francescaserrao cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT veliapurcaro cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT gennyraffaeli cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT stefaniavilla cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT danieleprati cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT isabellamondello cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT alessandrafalcone cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT marialetiziapatti cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT tizianaboggini cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT paolabergamaschi cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT domenicolepore cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT fabriziogaetanosaveriofranco cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT lorenzoorazi cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT iolandamozzetta cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT antoniobaldascino cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT caterinagiovannavalentini cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT emanuelalocatelli cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT robertoalbiani cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT federicogenzanobesso cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT giuliavaninacantone cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT alessandracoscia cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT alfonsotrimarchi cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT giacomocavallaro cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT stefanoghirardello cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext AT giovannivento cordredbloodcelltransfusionsforsevereretinopathyinpretermneonatesinitalyamulticenterrandomizedcontrolledtrialresearchincontext |