umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)
- Conditions
- Retinopathy of Prematurity
- Interventions
- Biological: adult donor RBC concentratesBiological: cord blood-RBC concentrates
- Registration Number
- NCT05100212
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- gestational age (GA) at birth between 24+0 and 27+6 weeks
- signed informed consent of parents.
One or more of the following:
- maternal-fetal immunization
- hydrops fetalis
- major congenital malformations associated or not with genetic syndromes
- previous transfusions
- hemorrhage at birth
- congenital infections
- health care team deeming it inappropriate to approach the infant's family for informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adult-RBC transfusions adult donor RBC concentrates Adult-red blood cell concentrate transfusions CB-RBC transfusions cord blood-RBC concentrates Cord blood-red blood cell concentrate transfusions
- Primary Outcome Measures
Name Time Method Retinopathy of prematurity up to the age of 40 weeks Incidence of severe ROP (stage 3 and higher) in CB-RBC and A-RBC arms
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Azienda Ospedaliero Universitaria Careggi
๐ฎ๐นFirenze, Italy
Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo,
๐ฎ๐นFoggia, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
๐ฎ๐นMilan, Italy
Ospedale Evangelico Villa Betania
๐ฎ๐นNaples, Italy
AORN Santobono-Pausilipon
๐ฎ๐นNapoli, Italy
Fondazione IRCCS Policlinico S. Matteo
๐ฎ๐นPavia, Italy
Azienda Ospedaliero Universitaria Pisana
๐ฎ๐นPisa, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
๐ฎ๐นReggio Calabria, Italy
Fondazione Policlinico Universitario A.Gemelli IRCCS
๐ฎ๐นRome, Italy
Cittร della Salute e della Scienza
๐ฎ๐นTorino, Italy