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| Name | Class |
|---|---|
| Fresenius Kabi | INDUSTRY |
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Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients. In this clinical setting, repeated red blood cell (RBC) transfusions independently predict a poor outcome, with a higher risk for mortality and morbidity. Recent studies from our own and other groups highlighted a close association between low levels of fetal hemoglobin (HbF) and severity of retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD), two disabilities that frequently complicate preterm birth. This association is not surprising, considering that 1) preterm neonates have a highly immature antioxidant reserve and both ROP and BPD rely on the oxidative damage as underlying mechanism; 2) in comparison with HbA, HbF is endowed with higher oxygen affinity, greater redox potential, higher tetrameric stability, and higher ability to generate unbound nitric oxide, all functions potentially protective in presence of an oxidative challenge; 3) in normal prenatal life, developing organ and tissues are exposed exclusively to HbF until last weeks of gestation; 4) in preterm neonates, the switch of the synthesis from HbF to HbA occurs around their due date, i.e., several weeks after the premature birth; 5) when preterm neonates receive transfusions, their tissues are abruptly exposed to high levels of HbA. We have recently run a pilot trial demonstrating as a proof-of-concept that transfusing cord blood red blood cell concentrates (CB-RBC) effectively prevents or restrains the HbF loss consequent to adult donor standard transfusions (A-RBC). This study explores the hypothesis that transfusing CB-RBCs instead of A-RBC may lower the incidence of severe ROP in ELGANs needing transfusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult-RBC transfusions | Active Comparator | Adult-red blood cell concentrate transfusions |
|
| CB-RBC transfusions | Experimental | Cord blood-red blood cell concentrate transfusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cord blood-RBC concentrates | Biological | Patients in the experimental arm are candidates to receive CB-RBC units until the completion of 29 weeks of postmenstrual age (29+6). In case of unavailability of an ABO/Rh matched CB-RBC unit, patients receive adult -RBC (standard transfusions). |
| Measure | Description | Time Frame |
|---|---|---|
| Retinopathy of prematurity | Incidence of severe ROP (stage 3 and higher) in CB-RBC and A-RBC arms | up to the age of 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
One or more of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Luciana Teofili, MD | Fondazione Policlinico Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Careggi | Florence | Italy | ||||
| Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39113069 | Derived | Teofili L, Papacci P, Dani C, Cresi F, Remaschi G, Pellegrino C, Bianchi M, Ansaldi G, Campagnoli MF, Vania B, Lepore D, Franco FGS, Fabbri M, de Vera d' Aragona RP, Molisso A, Beccastrini E, Dragonetti A, Orazi L, Pasciuto T, Mozzetta I, Baldascino A, Locatelli E, Valentini CG, Giannantonio C, Carducci B, Gabbriellini S, Albiani R, Ciabatti E, Nicolotti N, Baroni S, Mazzoni A, Besso FG, Serrao F, Purcaro V, Coscia A, Pizzolo R, Raffaeli G, Villa S, Mondello I, Trimarchi A, Beccia F, Ghirardello S, Vento G. Cord blood transfusions in extremely low gestational age neonates to reduce severe retinopathy of prematurity: results of a prespecified interim analysis of the randomized BORN trial. Ital J Pediatr. 2024 Aug 7;50(1):142. doi: 10.1186/s13052-024-01714-w. | |
| 36514106 |
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Interventional, randomized, controlled, double-blind, with an adaptive design to evaluate safety and efficacy of allogeneic CB-RBC transfusions.
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| adult donor RBC concentrates | Biological | Patients in the comparator arm are candidates to receive adult donor-RBC units |
|
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| Foggia |
| Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Italy |
| AORN Santobono-Pausilipon | Naples | Italy |
| Ospedale Evangelico Villa Betania | Naples | Italy |
| Fondazione IRCCS Policlinico S. Matteo | Pavia | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy |
| Azienda Ospedaliera Bianchi Melacrino Morelli | Reggio Calabria | Italy |
| Fondazione Policlinico Universitario A.Gemelli IRCCS | Rome | 00168 | Italy |
| Città della Salute e della Scienza | Torino | Italy |
| Derived |
| Teofili L, Papacci P, Orlando N, Bianchi M, Pasciuto T, Mozzetta I, Palluzzi F, Giaco L, Giannantonio C, Remaschi G, Santosuosso M, Beccastrini E, Fabbri M, Valentini CG, Bonfini T, Cloclite E, Accorsi P, Dragonetti A, Cresi F, Ansaldi G, Raffaeli G, Villa S, Pucci G, Mondello I, Santodirocco M, Ghirardello S, Vento G. 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. Trials. 2022 Dec 13;23(1):1010. doi: 10.1186/s13063-022-06949-8. |
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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