Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trial.

IF 10 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

EClinicalMedicine Pub Date : 2025-08-13 eCollection Date: 2025-09-01 DOI:10.1016/j.eclinm.2025.103426

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

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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).

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脐带红细胞输注治疗意大利早产儿严重视网膜病变：一项多中心随机对照试验

背景：红细胞（RBC）输注与早产儿视网膜病变（ROP）有关。方法：BORN是一项多中心随机试验，研究脐带血（cb -RBC）而非成人献血者（a -RBC）是否能降低ROP严重程度（NCT05100212）。该研究于2021年12月至2024年11月在意大利8个不同地区的8家医院进行。极低胎龄新生儿（elgan）从出生到经后年龄（PMA） 29 + 6周，按1:1的比例随机分为a -红细胞（对照组）或cb -红细胞（干预组）。主要观察指标为PMA或出院40周时的严重rop率。结果：通过意向-治疗分析，每组评估56例患者：对照组16例，干预组14例发生严重ROP （28.6% vs 25.0%，风险差异[RD] - 0.03 [95% CI - 0.21% ~ 0.14%]; P = 0.831）。干预组24例（42.8%）患者也接受了a -红细胞。按方案分析包括那些只接受指定治疗的患者，包括对照组的38个elgan和干预组的17个，具有可比的特征。对照组中有13例elgan出现严重ROP， 10例需要ROP治疗，而干预组中没有患者出现严重ROP或需要治疗的ROP（严重ROP为34.2%比0%，RD为- 0.34 [95% CI - 0.51%至- 0.07%],P = 0.005，需要治疗的ROP为26.3%比0%，RD为- 0.28 [95% CI - 0.46%至- 0.02%],P = 0.022）。对照组24例，干预组5例，出现中/重度BPD （63.2% vs 29.4%, RD = 0.33 [95% CI - 0.56% ~ - 0.02%], P = 0.039）。解释：cb - rbc可以保护elgan免受严重形式的ROP和BPD。资助：由费森尤斯血液护理意大利有限公司(Prot。N 0038762/21-04/11/2021;授权号5800134-FPG)。

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来源期刊

EClinicalMedicine Medicine-Medicine (all)

CiteScore

18.90

自引率

1.30%

发文量

506

审稿时长

22 days

期刊介绍： eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.