Principal investigator: Prof. Luciana Teofili – Medicina Trasfusionale, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica, ed Ematologia;
Co-Principal Investigator: Prof. Patrizia Papacci – Neonatologia, Dipartimento per le Scienze della Salute della Donna, del Bambino e di Sanità Pubblica. Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
In collaboration with: Tina Pasciuto, Iolanda Mozzetta, Gabriele Placidi, Paolo Casu – Data Collection; Fernando Palluzzi, Luciano Giaco’ – Bioinformatics
Promoted by Fondazione Policlinico A. Gemelli IRCSS, with the support of Fresenius HemoCare.
Registered at https://clinicaltrials.gov/ ; identifier NCT05100212.
Extremely low gestational age neonates (i.e., born before 28 gestation weeks) need repeated red blood cell concentrate transfusions from adult donors (A-RBC). A plenty of studies reported that repeated transfusions are associated with a high risk of mortality and morbidity. Recent observations showed a close association between low levels of fetal hemoglobin (HbF) and severity of retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD), suggesting that the harmful effect of transfusions is mediated by the progressive loss of HbF in recipients. According to a pilot study from our group, cord blood RBC (CB-RBC) transfusions maintain the HbF at significantly higher levels than A-RBC, potentially preventing ROP and BPD or strongly reducing their severity.
BORN study is recruiting premature neonates, with the goal of testing the efficacy of the innovative CB-RBC transfusion practice to reduce the incidence of severe forms of ROP over the standard transfusions. BORN also aims to estimate the optimal HbF level to prevent severe ROP and reduce severity of other prematurity associated diseases.
Study sites. BORN is an ongoing multi-center Italian study involving Cord Blood Banks and Neonatal Intensive Care Units.