[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643567":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":29,"collaborators":25,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":25,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"University of Parma","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cord Blood Red Blood Cell Transfusion (CB-RBC)","EXPERIMENTAL","The experimental intervention consists of transfusion of cord blood red blood cell concentrates (CB-RBC), prepared from cord blood units donated to public cord blood banks. The units are processed as follows:\n\n* Leukodepletion using BioR Flex filters;\n* Fractionation using Compomat G5 cell separators;\n* Suspension in SAG-M additive solution;\n* Storage in DEHP-free pediatric blood bags.\n\nAll units are irradiated with gamma rays prior to administration and transfused within 24 hours after irradiation. Safety is ensured through screening for infectious diseases (HIV, HBV, HCV, syphilis, bacterial and fungal cultures).\n\nThe dose, volume, and frequency of transfusion follow the same guidelines as adult red blood cell concentrates (A-RBC), according to current Italian neonatal standards. Transfusion is performed by the clinical staff of the Neonatology Unit according to the standard protocol.",[13],"Combination Product: Cord Blood Red Blood Cell Transfusion (CB-RBC)",{"label":15,"type":16,"description":17,"interventionNames":18},"Adult Donor Red Blood Cell Transfusion (A-RBC)","ACTIVE_COMPARATOR","The control arm receives transfusions of adult donor red blood cell concentrates (A-RBC), leukodepleted and irradiated according to the same thresholds and doses as the experimental arm, representing the Italian standard of care for anemic preterm neonates and ensuring that the only difference between the two arms is the source of the transfusion product - and therefore the HbF content - with respect to which CB-RBC is expected to demonstrate superiority",[19],"Other: Adult Donor Red Blood Cell Transfusion (A-RBC)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Transfusion of leukodepleted, gamma-irradiated cord blood-derived red blood cell concentrates (CB-RBC), prepared from donated public cord blood bank units, characterized by high fetal hemoglobin (HbF) content and administered according to standard neonatal transfusion thresholds",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Transfusion of leukodepleted, gamma-irradiated adult-donor derived red blood cell concentrates (A-RBC) administered according to standard neonatal transfusion thresholds.",[15],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Serafina Perrone","Professor of Pediatrics","100643567","personalizing-preterm-neonatal-transfusions-with-fetal-hemoglobin-enriched-cord-blood-100643567",false,"NCT07636473","Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood","Advancing Neonatal Health: Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood","ANH-Prestige","Inclusion Criteria:\n\n* Preterm neonates born between 24+0 and 31+6 weeks of gestational age;\n* Requirement for at least one red blood cell transfusion during hospitalization, according to current Italian transfusion thresholds;\n* Written informed consent obtained from parents or legal guardians prior to any study procedure.\n\nExclusion Criteria:\n\n* Gestational age \\> 32+0 weeks;\n* Pregnancy complicated by maternal-fetal alloimmunization (e.g., hemolytic disease of the newborn);\n* Pregnancy complicated by fetal hydrops;\n* Major congenital anomalies or genetic syndromes;\n* Previous red blood cell transfusions (prior to enrollment);\n* Perinatal hemorrhage at delivery;\n* Documented congenital infections (TORCH).","ALL","24 Weeks","31 Weeks",{"count":45,"type":46},200,"ESTIMATED","INTERVENTIONAL",[49],"NA","Long-term morbidities among very low birth weight infants remain a significant challenge. Oxidative stress is a key factor in the pathogenesis of 'free radical (FR) diseases of prematurity,' including retinopathy of prematurity, bronchopulmonary dysplasia, necrotizing enterocolitis, and intraventricular hemorrhage. Red blood cell (RBC) transfusions are recognized as a contributing factor to FR-related diseases. RBCs contain adult hemoglobin (HbA), which has a lower affinity for oxygen. This characteristic increases oxygen delivery and tissue uptake, leading to a potentially harmful state of hyperoxia and over-generation of FRs. The strategy employs a multidisciplinary approach to evaluate the impact of cord blood transfusions in anemic newborns. Results will be assessed in relation to short- and long-term neonatal outcomes to determine the effectiveness of this new preventive strategy. Improving the current data are critical for setting action priorities for and monitoring progress",[52,53],"Prematurity Complications","Anemia",[55,56,57],"Cord Blood red blood cells","transfusion","preterm newborns","NOT_YET_RECRUITING","2026-06-09",{"date":61,"type":62},"2026-06-11","ACTUAL",{"date":64,"type":46},"2026-11-01",{"date":66,"type":46},"2029-11-01",{"name":5,"class":6}]