[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fetal-hemoglobin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fetal-hemoglobin":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,110,153],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100644508","transfusion-related-changes-in-oxidative-stress-biomarkers-in-neonates-100644508",false,"NCT07672275","Transfusion-Related Changes in Oxidative Stress Biomarkers in Neonates","Transfusion-Related Changes in Oxidative Stress Biomarkers in Neonates - a Three-Part Prospective Observational Pilot Study","NEO-REDOX","Inclusion Criteria:\n\nPart A:\n\n* Neonates who are monitored on the NICU immediately after birth\n* Written parental informed consent\n\nPart B:\n\n* Term and preterm neonates admitted to the NICU for medical treatment\n* Age ad admission \\\u003C48 hours\n* Written parental informed consent\n\nPart C:\n\n* ELGANs 22(+5)-27(+6) weeks (days) gestation admitted to the NICU\n* Decision to conduct full life support\n* Written parental informed consent\n\nExclusion criteria (Part A, B, C)\n\n* No decision to conduct full life support\n* No parental written informed consent\n* Congenital malformations\n* Family history of hemoglobinopathies (e.g. sickle cell anemia, thalassemia)\n* Fetal anemia requiring in-utero A-RBC transfusions",true,"ALL","5 Minutes","5 Months",{"count":22,"type":23},170,"ESTIMATED","OBSERVATIONAL","Reactive oxygen species (ROS), which include peroxides, are generated in the human body as by-products of cellular metabolism. In small amounts, they fulfill important physiological functions. However, when produced in excess, they can damage cells and tissues. Extremely low gestation age neonates (ELGANs) are particularly vulnerable to such harmful effects because their antioxidant defense systems are immature, and they are exposed to increased ROS levels due to the oxygen therapy required after birth.\n\nFetal hemoglobin (HbF), the primary oxygen carrier in the blood of newborns, plays a crucial role in this context. Compared with adult hemoglobin (HbA), it has a higher oxygen affinity and a more pronounced pseudoperoxidase activity, which helps protect organs during early development from peroxides.\n\nIn addition to oxygen administration, blood transfusions can also contribute to increased ROS formation. Due to the immature hematopoietic system and the diagnostic blood sampling required, ELGANs frequently receive transfusions with adult red blood cell (A-RBC) concentrates. These lead to a rapid shift from HbF to HbA, further promoting the generation of ROS.\n\nMeasuring ROS in blood is particularly challenging because these molecules are extremely short-lived. Consequently, reference values for newborns are lacking. Therefore, the investigators aim to establish reference ranges for one ROS, the peroxide in both term and preterm healty neonates from birth event onward and to assess the effects of A-RBC transfusions on this parameter in ELGANs.\n\nFurthermore, combining near-infrared spectroscopy-derived measurements of cerebral regional tissue oxygenation with peroxide assessments requiring only minimal blood volumes (0.5 mL per sample) will provide a more comprehensive and quantitatively robust understanding of the physiological changes induced by A-RBC transfusions in ELGANs.\n\nExcessive ROS exposure is considered a key risk factor for severe complications of prematurity, including brain injury, retinopathy, and chronic lung disease. With this project, investigators aim to improve the understanding of these risks and promote new evidence-based strategies in transfusion medicine. In the long term, transfusions with HbF-rich red blood cells derived from cord blood could help reduce ROS formation and provide effective protection for particularly vulnerable preterm infants.",[27,28,29,30],"Oxidative Stress in Neonates","Near Infrared Spectroscopy","Fetal Hemoglobin","Erythrocyte Transfusion",[32,33,34,35,36],"fetal hemoglobin","erythrocyte transfusion","preterm neonates","peroxide","oxidative stress","RECRUITING","2026-06-23",{"date":40,"type":41},"2026-06-26","ACTUAL",{"date":43,"type":41},"2025-12-12",{"date":45,"type":23},"2028-02-01",{"name":47,"class":48},"Medical University of Graz","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":49},"100495785","phase-2-mt2021-08t-cell-receptor-alphabeta-depletion-pbsc-transplantation-for-heme-malignancies-100495785","NCT05735717","MT2021-08T Cell Receptor Alpha\u002FBeta Depletion PBSC Transplantation for Heme Malignancies","Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha\u002FBeta Depletion (A\u002FB TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies","Inclusion Criteria:\n\n* Histological confirmation of hematological malignancies\n* Acute leukemias\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms\n* Favorable risk AML is defined as having one of the following:\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.\n* Age 60 years of age or younger at the time of consent\n* Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active uncontrolled infection within 1 week of starting preparative therapy\n* Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.\n* Any prior autologous or allogeneic transplant\n* CML blast crisis\n* Active central nervous system malignancy","60 Years",{"count":59,"type":23},70,"INTERVENTIONAL",[62],"PHASE2","This is a phase II, open-label, prospective study of T cell receptor alpha\u002Fbeta depletion (TCR α\u002Fβ TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety\u002Ffeasibility study of the investigational procedure\u002Fproduct.",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,29,86,87],"Hematologic Malignancy","Acute Leukemia","Remission","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","AML","TP53","Intrachromosomal Amplification of Chromosome 21","Cytogenetic Abnormality","CNS Leukemia","Minimal Residual Disease","Myelodysplasia","Juvenile Myelomonocytic Leukemia","Somatic Mutation","PTPN11 Gene Mutation","N-RAS Gene Amplification","Neurofibromatosis 1","NF1 Mutation","CBL Gene Mutation","Monosomy 7","Chromosome Abnormality","Lymphoblastic Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult",[89,90,91,92,93,94,95,96,97,98,99,100],"Bu","Flu","G-CSF","GFSR","aGVHD","HCT","MAC","Mel","PBSCT","PTLD","RECIST","TCR","2026-03-31",{"date":103,"type":41},"2026-04-06",{"date":105,"type":41},"2023-05-11",{"date":107,"type":23},"2030-11-30",{"name":109,"class":48},"Masonic Cancer Center, University of Minnesota",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":18,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":60,"phases":121,"briefSummary":123,"conditions":124,"keywords":133,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":49},"100631599","heterologous-cord-blood-derived-red-blood-cell-for-transfusion-in-extremely-preterm-infants-100631599","NCT07502781","Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants","Multicenter, Randomized, Double-Blind Pilot Clinical Trial Evaluating the Impact of Transfusion With Heterologous Cord Blood-Derived Red Blood Cells Versus Adult Red Blood Cells in Extremely Premature Infants","Inclusion Criteria:\n\n* Signed informed consent obtained from parents or legal guardians.\n* Gestational age at birth \\\u003C 28 weeks or birth weight \\\u003C 1000 g.\n* Admission to one of the participating neonatal intensive care units (NICUs) in the Barcelona area.\n\nExclusion Criteria:\n\n* Prior red blood cell transfusion during the fetal or neonatal period.\n* Maternal-fetal immunization (e.g., isoimmunization).\n* Fetal hydrops.\n* Major congenital malformations.\n* Congenital infections.\n* Immediate need for blood before randomization (e.g., hemorrhagic shock, consumptive coagulopathy).\n* Participation in another clinical trial that could interfere with the primary outcome.","23 Weeks","28 Weeks",{"count":120,"type":23},176,[122],"NA","Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red blood cell transfusions during their hospital stay.\n\nCurrently, transfusions are given using red blood cells donated by adults. An alternative option is to use red blood cells collected from umbilical cord blood, which may be more similar to a newborn's own blood. This approach has been used in some neonatal units with encouraging results and no reported safety concerns.\n\nThis study aims to determine whether transfusion with umbilical cord blood improves clinical outcomes and reduces potential side effects compared to standard adult donor blood transfusion in extremely preterm infants. We hypothesize that umbilical cord blood transfusion will be at least as safe as adult donor blood and may provide clinical benefits.\n\nAbout 115 extremely preterm infants admitted to neonatal units in Catalonia will participate. If parents agree, their baby will be randomly assigned to receive either compatible umbilical cord blood or compatible adult donor blood if a transfusion becomes necessary. Babies will only receive a transfusion if they clinically need one. If cord blood is not available at the time of transfusion, the baby will receive compatible adult donor blood regardless of the assigned group.\n\nTo evaluate the response to treatment, small blood samples will be collected at birth, at one month of life, and 24 hours after any transfusion. These samples are taken at the same times as routine blood tests, so participation does not require additional needle sticks. The amount of blood collected is minimal (about 0.2 mL per sample).\n\nIn addition, a painless and non-invasive sensor will be placed on the baby's head for 24 hours to measure oxygen delivery to the brain. Urine samples will also be collected before and after transfusion to help assess how oxygen reaches body tissues.\n\nParticipation will continue until the baby reaches 36 weeks of postmenstrual age or is discharged from the hospital, whichever comes first.",[125,126,127,128,29,129,130,131,132],"Extremely Premature Infant","Anemia Neonatal","Blood Transfusion","Umbilical Cord Blood","Bronchopulmonary Dysplasia (BPD)","Retinopathy of Prematurity (ROP)","Death; Neonatal","Intensive Care Units, Neonatal",[134,135,136,137,138,139,140,141,142,143],"Cord blood red blod cell transfusion","Umbilical cord blood transfusion","Extremely preterm infants","Neonatal anemia","Fetal hemoglobin","Adult donor red blood cells","Bronchopulmonary dysplasia","Retinopathy of prematurity","Oxygen delivery","Days requiring oxygen supplementation","NOT_YET_RECRUITING","2026-03-27",{"date":101,"type":41},{"date":148,"type":23},"2027-01",{"date":150,"type":23},"2029-12",{"name":152,"class":48},"Hospital Clinic of Barcelona",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":18,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":60,"phases":164,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":49},"100553787","phase-2-unraveling-the-impact-of-thalidomide-at-diverse-doses-in-transfusion-dependent-beta-thalassemia-100553787","NCT06490627","Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia","BTM","Inclusion Criteria:\n\n* Know case of beta thalassemia major\u002F intermediate ( transfusion dependent)\n* willing to give informed consent\n\nExclusion Criteria:\n\n* Patients with comorbidities such as liver dysfunction\n* Married patients\n* Lactating mother\n* H\u002FO thrombosis and fits","8 Years","35 Years",{"count":163,"type":23},54,[62],"The project \"Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia\" investigates the safety and efficacy of low-dose thalidomide in managing beta thalassemia, a genetic disorder causing anemia. Conducted over two years at NIBD hospital, the study involves 54 transfusion-dependent patients aged 8-35. The primary objective is to correlate thalidomide doses with disease severity, adverse effects, and treatment response, aiming to optimize treatment strategies and reduce side effects.\n\nData will be collected through clinical interviews and medical record reviews and analyzed using SPSS. Key variables include hemoglobin levels, leukocyte and reticulocyte counts, platelets, liver and spleen size, genetic modifiers, and transfusion frequency. Inclusion criteria are specific to beta thalassemia patients, while exclusion criteria rule out those with liver dysfunction, married patients, lactating mothers, and those with a history of thrombosis or fits.",[29,167,168],"Thalassemia Major","Genetic Disease",[170,171,172,173],"thalidomide","safety and efficacy","thalassemia","fetal hemoglobin inducer","2025-05-26",{"date":176,"type":41},"2025-05-30",{"date":178,"type":41},"2024-04-22",{"date":180,"type":23},"2026-04-22",{"name":182,"class":183},"National Institute of Blood and Marrow Transplant (NIBMT), Pakistan","OTHER_GOV"]