[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemolytic-disease-of-the-fetus-and-newborn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemolytic-disease-of-the-fetus-and-newborn":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100607862","a-study-on-hemolytic-disease-of-the-fetus-and-newborn-hdfn-through-global-registry-100607862",false,"NCT07194070","A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry","Global Prospective Hemolytic Disease of the Fetus and Newborn Registry","GERANIUM","Inclusion Criteria:\n\n* Pregnant with an estimated gestational age (GA) (based on ultrasound dating) up to week 24\n* History of a previous alloimmunized pregnancy that included at least one of the following: Fetal anemia diagnosed by middle cerebral artery (MCA) doppler ultrasound; Received greater than or equal to (\\>=) 1 intrauterine transfusion (IUT) as a result of hemolytic disease of the fetus and newborn (HDFN); Fetal hydrops; Stillbirth or fetal demise with fetal or placental pathology indicative of HDFN; Neonatal exchange transfusion due to HDFN; Neonatal simple transfusion due to HDFN; Neonatal hyperbilirubinemia due to HDFN; Positive direct antiglobulin test (DAT) in neonate\n* Documented presence of maternal alloantibody based on local laboratory results during current pregnancy\n* Evidence of an antigen-positive fetus corresponding to the current maternal alloantibody: Fetal antigen status confirmed by cell-free fetal DNA (cffDNA); OR Fetal antigen status confirmed by amniocentesis; OR Paternal genotype confirmed\n* Pregnant participant or a legally acceptable representative has provided informed consent (per local regulations or ethics committee requirements) for the collection and use of their medical data and the medical data for their corresponding fetuses\u002Fneonates\u002Finfants\u002Fchildren\n\nExclusion Criteria:\n\n* Participant actively participating in an interventional trial of an investigational agent\n* At risk for HDFN due to ABO being the sole alloimmunization antigen in the current pregnancy (that is, ABO plus another antigen is permissible)","FEMALE","18 Years",{"count":20,"type":21},175,"ESTIMATED","2 Years","OBSERVATIONAL","The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk for hemolytic disease of the fetus and newborn (HDFN) and receiving standard of care (SoC). HDFN is a blood disease that occurs in babies before birth or just after birth when the blood types of the pregnant individual and babies are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the fetus\u002Fbaby.",[26],"Hemolytic Disease of the Fetus and Newborn","RECRUITING","2026-06-04",{"date":30,"type":31},"2026-06-05","ACTUAL",{"date":33,"type":31},"2025-12-17",{"date":35,"type":21},"2030-09-30",{"name":37,"class":38},"Janssen Research & Development, LLC","INDUSTRY",13,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100509368","phase-3-a-study-of-nipocalimab-in-pregnancies-at-risk-for-severe-hemolytic-disease-of-the-fetus-and-newborn-hdfn-100509368","NCT05912517","A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)","A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)","AZALEA","Inclusion Criteria:\n\n* Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13\\^0\u002F7 to Week 18\\^6\u002F7 at randomization\n* History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as documented:\n\n  1. fetal anemia as result of HDFN or fetal hydrops as result of HDFN or received greater than or equal to (\\>=)1 IUT as a result of HDFN or\n  2. fetal loss or neonatal death as a result of HDFN, with maternal alloantibody titers for Rhesus antigen D protein (RhD), Kell, Kell Rhesus antigen C protein (Rhc), Rhesus antigen E protein (RhE), or RhC antigen above the critical levels (anti-Kell \\>=4; other \\>=16) and evidence of an antigen-positive fetus\n* During the current pregnancy, presence of maternal alloantibody to RhD, Rhc, RhE, or RhC antigen with titers above the critical level (anti-Kell \\>= 4; other \\>=16) based on the designated central lab results at screening\n* Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cell-free fetal DNA (cffDNA) performed at the central laboratory\n* Have screening lab test results within values within the study protocol-specified parameters: a) albumin \\>= lower limit of normal (LLN); b) alanine transaminase (AST) less than or equal to (\\\u003C=) 2 × upper limit of normal (ULN); c) alanine transaminase (ALT) \\\u003C=2 × ULN d) creatinine \\\u003C=0.8 milligrams per deciliter (mg\u002FdL), SI: \\\u003C=70.7 micromole per liter (μmol\u002FL), and Serum total immunoglobulins G (IgG) ≥ 600 mg\u002FdL SI: \\>=6 g\u002FL\n* Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical lab tests performed at screening\n\nExclusion Criteria:\n\n* Currently pregnant with a multiple gestation (twins or more)\n* Evidence of fetal anemia prior to randomization in the current pregnancy\n* History of severe preeclampsia prior to GA Week 34 or severe fetal growth restriction (estimated fetal weight \\\u003C3rd percentile, based on local fetal growth normative standards) in a previous pregnancy\n* Current uncontrolled hypertension\n* History of myocardial infarction, unstable ischemic heart disease, or stroke\n* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Has inflammatory or autoimmune diseases requiring immunosuppressive therapies that may jeopardize the safety of the participant\n* Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and\u002For squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study intervention)\n* Is currently receiving systemic corticosteroids or other immunosuppressants for disorders unrelated to the pregnancy\n* Has received or planning to receive plasmapheresis, immunoadsorption therapy, intravenous immunoglobulin (IV Ig), or any immunoglobulin (Ig)G fragment crystallizable (Fc)-related protein therapeutics during the current pregnancy\n* Has a severe infection including opportunistic infections\n* Presence of abnormal (protocol-specified) hematologic lab values during screening\n* History of an unprovoked pulmonary embolism or history of recurrent deep vein thrombosis (DVT)\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","45 Years",{"count":50,"type":21},120,"INTERVENTIONAL",[53],"PHASE3","The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.",[26],{"date":30,"type":31},{"date":58,"type":31},"2023-12-20",{"date":60,"type":21},"2029-10-08",{"name":37,"class":38},62,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100591747","cord-blood-s100b-protein-levels-in-neonates-following-intrauterine-transfusions-for-hdfn-associated-fetal-anemia-100591747","NCT06984445","Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia","Analysis of Cord Blood S100B Protein Levels in Neonates With Fetal Anemia Due to Hemolytic Disease Undergoing Intrauterine Transfusions: A Prospective Cohort Study","Study Group - Inclusion Criteria:\n\n1. Singleton pregnancy.\n2. Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.\n3. Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.\n4. Fetal anemia requiring IUT, indicated by a MCA-PSV MoM value exceeding 1.5.\n\nStudy Group - Exclusion Criteria:\n\n1\\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).\n\nControl Group - Inclusion Criteria:\n\n1. Singleton pregnancy.\n2. Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.\n3. Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.\n4. No indications for IUT, as determined by MCA-PSV MoM values \\\u003C1.5 in routine assessments of fetal cerebral arterial flow.\n\nControl Group - Exclusion Criteria:\n\n1\\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).",{"count":71,"type":21},180,"levated levels of S100B protein are a well-established marker of central nervous system (CNS) damage. Fetal anemia resulting from hemolytic disease of the fetus and newborn (HDFN) often necessitates intrauterine transfusions (IUTs) and represents a significant risk factor for CNS injury. However, it remains uncertain whether S100B protein levels can reliably predict which fetuses are at higher risk for CNS complications in this context. Furthermore, the potential role of measuring S100B concentrations before IUT in prenatal assessments, and its relationship to the severity of anemia and fetal cerebral blood flow, remains poorly understood. This study aims to investigate the concentration of S100B protein in cord blood from newborns with HDFN-related fetal anemia requiring IUT. The study group comprises pregnancies complicated by HDFN with abnormal middle cerebral artery (MCA) blood flow, indicating the need for IUT. In this group, S100B protein levels will be measured before each IUT, with additional measurements if further transfusions are required. The control group consists of pregnancies with HDFN that do not require IUT. Cord blood samples will be collected at birth to evaluate S100B protein levels in both groups. Additionally, fetal MCA blood flow will be monitored, and in the study group, fetal hemoglobin and hematocrit levels will be assessed before each IUT. The primary endpoints of the study include the measurement of cord blood S100B protein levels before IUT in the study group and at birth in both groups. Secondary endpoints will explore the potential correlations between S100B protein levels and umbilical cord blood gas parameters (e.g., pH, BE, lactate), fetal cerebral blood flow parameters (e.g., MCA-PSV values), and blood count parameters (e.g., hemoglobin and hematocrit levels), both before IUT in the study group and after birth in both groups.",[74,75,26,76],"s100b","Hypoxia-Ischemia, Brain","Fetal Anemia",[78,79,80,81,82,83,84],"S100B protein","hemolytic disease of fetus and newborn (HDFN)","intrauterine transfusion (IUT)","fetal anemia","newborn","central nervous system (CNS) damage","CNS hypoxia-ischemia (HI)","2025-05-14",{"date":87,"type":31},"2025-05-22",{"date":89,"type":31},"2024-07-17",{"date":91,"type":21},"2026-04-30",{"name":93,"class":94},"Institute of Mother and Child, Warsaw, Poland","OTHER",1]