BORN study: 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

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. Registered on October 29, 2021 Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Teofili, Luciana [verfasserIn] Papacci, Patrizia Orlando, Nicoletta Bianchi, Maria Pasciuto, Tina Mozzetta, Iolanda Palluzzi, Fernando Giacò, Luciano Giannantonio, Carmen Remaschi, Giulia Santosuosso, Michela Beccastrini, Enrico Fabbri, Marco Valentini, Caterina Giovanna Bonfini, Tiziana Cloclite, Eleonora Accorsi, Patrizia Dragonetti, Antonella Cresi, Francesco Ansaldi, Giulia Raffaeli, Genny Villa, Stefania Pucci, Giulia Mondello, Isabella Santodirocco, Michele Ghirardello, Stefano Vento, Giovanni

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	Extremely low gestational age neonates Retinopathy of prematurity Transfusions Fetal hemoglobin Umbilical blood Randomized controlled trial

Anmerkung:	© The Author(s) 2022

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 23(2022), 1 vom: 13. Dez.
Übergeordnetes Werk:	volume:23 ; year:2022 ; number:1 ; day:13 ; month:12

Links:	Volltext

DOI / URN:	10.1186/s13063-022-06949-8

Katalog-ID:	SPR051232006

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520			\|a 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. Registered on October 29, 2021
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700	1		\|a Papacci, Patrizia \|4 aut
700	1		\|a Orlando, Nicoletta \|4 aut
700	1		\|a Bianchi, Maria \|4 aut
700	1		\|a Pasciuto, Tina \|4 aut
700	1		\|a Mozzetta, Iolanda \|4 aut
700	1		\|a Palluzzi, Fernando \|4 aut
700	1		\|a Giacò, Luciano \|4 aut
700	1		\|a Giannantonio, Carmen \|4 aut
700	1		\|a Remaschi, Giulia \|4 aut
700	1		\|a Santosuosso, Michela \|4 aut
700	1		\|a Beccastrini, Enrico \|4 aut
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allfields	10.1186/s13063-022-06949-8 doi (DE-627)SPR051232006 (SPR)s13063-022-06949-8-e DE-627 ger DE-627 rakwb eng Teofili, Luciana verfasserin (orcid)0000-0002-7214-1561 aut BORN study: 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 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. Registered on October 29, 2021 Extremely low gestational age neonates (dpeaa)DE-He213 Retinopathy of prematurity (dpeaa)DE-He213 Transfusions (dpeaa)DE-He213 Fetal hemoglobin (dpeaa)DE-He213 Umbilical blood (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Papacci, Patrizia aut Orlando, Nicoletta aut Bianchi, Maria aut Pasciuto, Tina aut Mozzetta, Iolanda aut Palluzzi, Fernando aut Giacò, Luciano aut Giannantonio, Carmen aut Remaschi, Giulia aut Santosuosso, Michela aut Beccastrini, Enrico aut Fabbri, Marco aut Valentini, Caterina Giovanna aut Bonfini, Tiziana aut Cloclite, Eleonora aut Accorsi, Patrizia aut Dragonetti, Antonella aut Cresi, Francesco aut Ansaldi, Giulia aut Raffaeli, Genny aut Villa, Stefania aut Pucci, Giulia aut Mondello, Isabella aut Santodirocco, Michele aut Ghirardello, Stefano aut Vento, Giovanni aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 13. Dez. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:13 month:12 https://dx.doi.org/10.1186/s13063-022-06949-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13 12
spelling	10.1186/s13063-022-06949-8 doi (DE-627)SPR051232006 (SPR)s13063-022-06949-8-e DE-627 ger DE-627 rakwb eng Teofili, Luciana verfasserin (orcid)0000-0002-7214-1561 aut BORN study: 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 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. Registered on October 29, 2021 Extremely low gestational age neonates (dpeaa)DE-He213 Retinopathy of prematurity (dpeaa)DE-He213 Transfusions (dpeaa)DE-He213 Fetal hemoglobin (dpeaa)DE-He213 Umbilical blood (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Papacci, Patrizia aut Orlando, Nicoletta aut Bianchi, Maria aut Pasciuto, Tina aut Mozzetta, Iolanda aut Palluzzi, Fernando aut Giacò, Luciano aut Giannantonio, Carmen aut Remaschi, Giulia aut Santosuosso, Michela aut Beccastrini, Enrico aut Fabbri, Marco aut Valentini, Caterina Giovanna aut Bonfini, Tiziana aut Cloclite, Eleonora aut Accorsi, Patrizia aut Dragonetti, Antonella aut Cresi, Francesco aut Ansaldi, Giulia aut Raffaeli, Genny aut Villa, Stefania aut Pucci, Giulia aut Mondello, Isabella aut Santodirocco, Michele aut Ghirardello, Stefano aut Vento, Giovanni aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 13. Dez. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:13 month:12 https://dx.doi.org/10.1186/s13063-022-06949-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13 12
allfields_unstemmed	10.1186/s13063-022-06949-8 doi (DE-627)SPR051232006 (SPR)s13063-022-06949-8-e DE-627 ger DE-627 rakwb eng Teofili, Luciana verfasserin (orcid)0000-0002-7214-1561 aut BORN study: 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 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. Registered on October 29, 2021 Extremely low gestational age neonates (dpeaa)DE-He213 Retinopathy of prematurity (dpeaa)DE-He213 Transfusions (dpeaa)DE-He213 Fetal hemoglobin (dpeaa)DE-He213 Umbilical blood (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Papacci, Patrizia aut Orlando, Nicoletta aut Bianchi, Maria aut Pasciuto, Tina aut Mozzetta, Iolanda aut Palluzzi, Fernando aut Giacò, Luciano aut Giannantonio, Carmen aut Remaschi, Giulia aut Santosuosso, Michela aut Beccastrini, Enrico aut Fabbri, Marco aut Valentini, Caterina Giovanna aut Bonfini, Tiziana aut Cloclite, Eleonora aut Accorsi, Patrizia aut Dragonetti, Antonella aut Cresi, Francesco aut Ansaldi, Giulia aut Raffaeli, Genny aut Villa, Stefania aut Pucci, Giulia aut Mondello, Isabella aut Santodirocco, Michele aut Ghirardello, Stefano aut Vento, Giovanni aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 13. Dez. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:13 month:12 https://dx.doi.org/10.1186/s13063-022-06949-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13 12
allfieldsGer	10.1186/s13063-022-06949-8 doi (DE-627)SPR051232006 (SPR)s13063-022-06949-8-e DE-627 ger DE-627 rakwb eng Teofili, Luciana verfasserin (orcid)0000-0002-7214-1561 aut BORN study: 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 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. Registered on October 29, 2021 Extremely low gestational age neonates (dpeaa)DE-He213 Retinopathy of prematurity (dpeaa)DE-He213 Transfusions (dpeaa)DE-He213 Fetal hemoglobin (dpeaa)DE-He213 Umbilical blood (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Papacci, Patrizia aut Orlando, Nicoletta aut Bianchi, Maria aut Pasciuto, Tina aut Mozzetta, Iolanda aut Palluzzi, Fernando aut Giacò, Luciano aut Giannantonio, Carmen aut Remaschi, Giulia aut Santosuosso, Michela aut Beccastrini, Enrico aut Fabbri, Marco aut Valentini, Caterina Giovanna aut Bonfini, Tiziana aut Cloclite, Eleonora aut Accorsi, Patrizia aut Dragonetti, Antonella aut Cresi, Francesco aut Ansaldi, Giulia aut Raffaeli, Genny aut Villa, Stefania aut Pucci, Giulia aut Mondello, Isabella aut Santodirocco, Michele aut Ghirardello, Stefano aut Vento, Giovanni aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 13. Dez. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:13 month:12 https://dx.doi.org/10.1186/s13063-022-06949-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13 12
allfieldsSound	10.1186/s13063-022-06949-8 doi (DE-627)SPR051232006 (SPR)s13063-022-06949-8-e DE-627 ger DE-627 rakwb eng Teofili, Luciana verfasserin (orcid)0000-0002-7214-1561 aut BORN study: 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 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. Registered on October 29, 2021 Extremely low gestational age neonates (dpeaa)DE-He213 Retinopathy of prematurity (dpeaa)DE-He213 Transfusions (dpeaa)DE-He213 Fetal hemoglobin (dpeaa)DE-He213 Umbilical blood (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Papacci, Patrizia aut Orlando, Nicoletta aut Bianchi, Maria aut Pasciuto, Tina aut Mozzetta, Iolanda aut Palluzzi, Fernando aut Giacò, Luciano aut Giannantonio, Carmen aut Remaschi, Giulia aut Santosuosso, Michela aut Beccastrini, Enrico aut Fabbri, Marco aut Valentini, Caterina Giovanna aut Bonfini, Tiziana aut Cloclite, Eleonora aut Accorsi, Patrizia aut Dragonetti, Antonella aut Cresi, Francesco aut Ansaldi, Giulia aut Raffaeli, Genny aut Villa, Stefania aut Pucci, Giulia aut Mondello, Isabella aut Santodirocco, Michele aut Ghirardello, Stefano aut Vento, Giovanni aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 13. Dez. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:13 month:12 https://dx.doi.org/10.1186/s13063-022-06949-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13 12
language	English
source	Enthalten in Trials 23(2022), 1 vom: 13. Dez. volume:23 year:2022 number:1 day:13 month:12
sourceStr	Enthalten in Trials 23(2022), 1 vom: 13. Dez. volume:23 year:2022 number:1 day:13 month:12
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Extremely low gestational age neonates Retinopathy of prematurity Transfusions Fetal hemoglobin Umbilical blood Randomized controlled trial
isfreeaccess_bool	true
container_title	Trials
authorswithroles_txt_mv	Teofili, Luciana @@aut@@ Papacci, Patrizia @@aut@@ Orlando, Nicoletta @@aut@@ Bianchi, Maria @@aut@@ Pasciuto, Tina @@aut@@ Mozzetta, Iolanda @@aut@@ Palluzzi, Fernando @@aut@@ Giacò, Luciano @@aut@@ Giannantonio, Carmen @@aut@@ Remaschi, Giulia @@aut@@ Santosuosso, Michela @@aut@@ Beccastrini, Enrico @@aut@@ Fabbri, Marco @@aut@@ Valentini, Caterina Giovanna @@aut@@ Bonfini, Tiziana @@aut@@ Cloclite, Eleonora @@aut@@ Accorsi, Patrizia @@aut@@ Dragonetti, Antonella @@aut@@ Cresi, Francesco @@aut@@ Ansaldi, Giulia @@aut@@ Raffaeli, Genny @@aut@@ Villa, Stefania @@aut@@ Pucci, Giulia @@aut@@ Mondello, Isabella @@aut@@ Santodirocco, Michele @@aut@@ Ghirardello, Stefano @@aut@@ Vento, Giovanni @@aut@@
publishDateDaySort_date	2022-12-13T00:00:00Z
hierarchy_top_id	326173552
id	SPR051232006
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR051232006</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230509122601.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230508s2022 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13063-022-06949-8</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR051232006</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13063-022-06949-8-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Teofili, Luciana</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-7214-1561</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">BORN study: 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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s) 2022</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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author	Teofili, Luciana
spellingShingle	Teofili, Luciana misc Extremely low gestational age neonates misc Retinopathy of prematurity misc Transfusions misc Fetal hemoglobin misc Umbilical blood misc Randomized controlled trial BORN study: 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
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topic_title	BORN study: 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 Extremely low gestational age neonates (dpeaa)DE-He213 Retinopathy of prematurity (dpeaa)DE-He213 Transfusions (dpeaa)DE-He213 Fetal hemoglobin (dpeaa)DE-He213 Umbilical blood (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213
topic	misc Extremely low gestational age neonates misc Retinopathy of prematurity misc Transfusions misc Fetal hemoglobin misc Umbilical blood misc Randomized controlled trial
topic_unstemmed	misc Extremely low gestational age neonates misc Retinopathy of prematurity misc Transfusions misc Fetal hemoglobin misc Umbilical blood misc Randomized controlled trial
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title	BORN study: 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
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title_full	BORN study: 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
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author_browse	Teofili, Luciana Papacci, Patrizia Orlando, Nicoletta Bianchi, Maria Pasciuto, Tina Mozzetta, Iolanda Palluzzi, Fernando Giacò, Luciano Giannantonio, Carmen Remaschi, Giulia Santosuosso, Michela Beccastrini, Enrico Fabbri, Marco Valentini, Caterina Giovanna Bonfini, Tiziana Cloclite, Eleonora Accorsi, Patrizia Dragonetti, Antonella Cresi, Francesco Ansaldi, Giulia Raffaeli, Genny Villa, Stefania Pucci, Giulia Mondello, Isabella Santodirocco, Michele Ghirardello, Stefano Vento, Giovanni
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title_sort	born study: 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
title_auth	BORN study: 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
abstract	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. Registered on October 29, 2021 © The Author(s) 2022
abstractGer	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. Registered on October 29, 2021 © The Author(s) 2022
abstract_unstemmed	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. Registered on October 29, 2021 © The Author(s) 2022
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title_short	BORN study: 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
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up_date	2024-07-03T20:34:36.662Z
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR051232006</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230509122601.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230508s2022 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13063-022-06949-8</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR051232006</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13063-022-06949-8-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Teofili, Luciana</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-7214-1561</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">BORN study: 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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s) 2022</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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BORN study: 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

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