%0 Journal Article
%T 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.
%A Teofili L
%A Papacci P
%A Dani C
%A Cresi F
%A Remaschi G
%A Pellegrino C
%A Bianchi M
%A Ansaldi G
%A Campagnoli MF
%A Vania B
%A Lepore D
%A Franco FGS
%A Fabbri M
%A de Vera d' Aragona RP
%A Molisso A
%A Beccastrini E
%A Dragonetti A
%A Orazi L
%A Pasciuto T
%A Mozzetta I
%A Baldascino A
%A Locatelli E
%A Valentini CG
%A Giannantonio C
%A Carducci B
%A Gabbriellini S
%A Albiani R
%A Ciabatti E
%A Nicolotti N
%A Baroni S
%A Mazzoni A
%A Besso FG
%A Serrao F
%A Purcaro V
%A Coscia A
%A Pizzolo R
%A Raffaeli G
%A Villa S
%A Mondello I
%A Trimarchi A
%A Beccia F
%A Ghirardello S
%A Vento G
%J Ital J Pediatr
%V 50
%N 1
%D 2024 Aug 7
%M 39113069
%F 3.288
%R 10.1186/s13052-024-01714-w
%X <B>BACKGROUND: </B>Preterm infants are at high risk for retinopathy of prematurity (ROP), with potential life-long visual impairment. Low fetal hemoglobin (HbF) levels predict ROP. It is unknown if preventing the HbF decrease also reduces ROP.<BR><B>METHODS: </B>BORN is an ongoing multicenter double-blinded randomized controlled trial investigating whether transfusing HbF-enriched cord blood-red blood cells (CB-RBCs) instead of adult donor-RBC units (A-RBCs) reduces the incidence of severe ROP (NCT05100212). Neonates born between 24 and 27 + 6 weeks of gestation are enrolled and randomized 1:1 to receive adult donor-RBCs (A-RBCs, arm A) or allogeneic CB-RBCs (arm B) from birth to the postmenstrual age (PMA) of 31 + 6 weeks. Primary outcome is the rate of severe ROP at 40 weeks of PMA or discharge, with a sample size of 146 patients. A prespecified interim analysis was scheduled after the first 58 patients were enrolled, with the main purpose to evaluate the safety of CB-RBC transfusions.<BR><B>RESULTS: </B>Results in the intention-to-treat and per-protocol analysis are reported. Twenty-eight patients were in arm A and 30 in arm B. Overall, 104 A-RBC units and 49 CB-RBC units were transfused, with a high rate of protocol deviations. A total of 336 adverse events were recorded, with similar incidence and severity in the two arms. By per-protocol analysis, patients receiving A-RBCs or both RBC types experienced more adverse events than non-transfused patients or those transfused exclusively with CB-RBCs, and suffered from more severe forms of bradycardia, pulmonary hypertension, and hemodynamically significant patent ductus arteriosus. Serum potassium, lactate, and pH were similar after CB-RBCs or A-RBCs. Fourteen patients died and 44 were evaluated for ROP. Ten of them developed severe ROP, with no differences between arms. At per-protocol analysis each A-RBC transfusion carried a relative risk for severe ROP of 1.66 (95% CI 1.06-2.20) in comparison with CB-RBCs. The area under the curve of HbF suggested that HbF decrement before 30 weeks PMA is critical for severe ROP development. Subsequent CB-RBC transfusions do not lessen the ROP risk.<BR><B>CONCLUSIONS: </B>The interim analysis shows that CB-RBC transfusion strategy in preterm neonates is safe and, if early adopted, might protect them from severe ROP.<BR><B>BACKGROUND: </B>Prospectively registered at ClinicalTrials.gov on October 29, 2021. Identifier number NCT05100212.