[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591747":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":64,"centralContacts":69,"locations":78,"responsibleParty":110,"collaborators":10,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":10,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":10,"enrollmentInfo":122,"targetDuration":10,"studyType":125,"phases":10,"briefSummary":126,"conditions":127,"keywords":132,"overallStatus":81,"whyStopped":10,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Institute of Mother and Child, Warsaw, Poland","OTHER",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group",null,"Pregnant women with HDFN-related fetal anemia requiring intrauterine transfusion (IUT). The need for IUT is determined based on prenatal ultrasound assessment of the peak systolic velocity in the middle cerebral artery (MCA-PSV), expressed as multiples of the median (MoM). A MoM value greater than 1.5 is indicative of severe fetal anemia and serves as the primary criterion for IUT.",[13,14,15,16,17,18,19,20,21],"Diagnostic Test: Cord blood S100B protein level prior to IUT","Diagnostic Test: Umbilical cord blood gas analysis prior to IUT","Diagnostic Test: Fetal blood count evaluation prior to IUT","Diagnostic Test: Cord blood S100B protein concentration at birth","Diagnostic Test: Umbilical cord blood gas analysis at birth","Diagnostic Test: Complete blood count after birth","Diagnostic Test: Ultrasound evaluation of fetal blood flow","Diagnostic Test: Neonatal transfontanelle ultrasound assessment","Diagnostic Test: Complete blood count analysis in cord blood at birth",{"label":23,"type":10,"description":24,"interventionNames":25},"Control group","Women with pregnancies complicated by HDFN who do not meet the criteria for intrauterine transfusion (IUT).",[16,17,18,19,20,21],[27,32,36,40,44,48,52,56,60],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DIAGNOSTIC_TEST","Cord blood S100B protein level prior to IUT","One milliliter of cord blood will be collected before each IUT procedure to measure S100B protein concentration. The sample will be labeled with the mother's name, date of birth, collection date, and IUT indication, then sent to the laboratory for centrifugation.",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Umbilical cord blood gas analysis prior to IUT","Half a milliliter of cord blood will be collected before each IUT procedure for immediate umbilical cord blood gas analysis, including pH, base excess (BE), and lactate levels.",[9],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"Fetal blood count evaluation prior to IUT","Fetal blood count data, including hemoglobin and hematocrit levels, will be collected before each IUT procedure.",[9],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"Cord blood S100B protein concentration at birth","After delivery, one milliliter of blood will be collected from the severed umbilical cord to measure the concentration of S100B protein. The sample will be labeled with the mother's name, the child's birth date and sex, and the collection date, before being sent to the laboratory for centrifugation.",[23,9],{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":10},"Umbilical cord blood gas analysis at birth","After birth, 0.5 mL of blood will be collected from the severed umbilical cord to assess pH, base excess (BE), and lactate levels in an umbilical cord blood gas analysis.",[23,9],{"type":28,"name":49,"description":50,"armGroupLabels":51,"otherNames":10},"Complete blood count after birth","Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured within six hours after birth.",[23,9],{"type":28,"name":53,"description":54,"armGroupLabels":55,"otherNames":10},"Ultrasound evaluation of fetal blood flow","Fetal cerebral blood flow will be routinely assessed via ultrasound, including measurements of MCA-PSV values.",[23,9],{"type":28,"name":57,"description":58,"armGroupLabels":59,"otherNames":10},"Neonatal transfontanelle ultrasound assessment","A transfontanelle ultrasound examination will. be performed to assess for any abnormalities in the newborn.",[23,9],{"type":28,"name":61,"description":62,"armGroupLabels":63,"otherNames":10},"Complete blood count analysis in cord blood at birth","Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured in cord blood samples collected at birth.",[23,9],[65],{"name":66,"affiliation":67,"role":68},"Agnieszka A. Drozdowska-Szymczak, MD, PhD","Institute of Mother and Child in Warsaw, Poland","PRINCIPAL_INVESTIGATOR",[70,74],{"name":66,"role":71,"phone":72,"phoneExt":10,"email":73},"CONTACT","+48 22 32 77 411","agnieszka.drozdowska@imid.med.pl",{"name":75,"role":71,"phone":76,"phoneExt":10,"email":77},"Sabina A. Łukawska, MD","+48 691 235 077","sabina.lukawska@imid.med.pl",[79],{"facility":80,"status":81,"city":82,"state":10,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Institute of Mother and Child","RECRUITING","Warsaw","01-211","Poland","PL",{"type":87,"coordinates":88},"Point",[89,90],21.01178,52.22977,{"lat":90,"lon":89},[93,94,95,98,100,102,104,106,108,109],{"name":66,"role":71,"phone":72,"phoneExt":10,"email":73},{"name":75,"role":71,"phone":76,"phoneExt":10,"email":77},{"name":96,"role":97,"phone":10,"phoneExt":10,"email":10},"Natalia Mazanowska, MD, PhD","SUB_INVESTIGATOR",{"name":99,"role":97,"phone":10,"phoneExt":10,"email":10},"Beata Broniarek-Samson",{"name":101,"role":97,"phone":10,"phoneExt":10,"email":10},"Jakub Zdulski",{"name":103,"role":97,"phone":10,"phoneExt":10,"email":10},"Ewa Mierzejewska, PhD",{"name":105,"role":97,"phone":10,"phoneExt":10,"email":10},"Tadeusz Issat, MD, PhD",{"name":107,"role":97,"phone":10,"phoneExt":10,"email":10},"Paweł Krajewski, MD, PhD",{"name":66,"role":68,"phone":10,"phoneExt":10,"email":10},{"name":75,"role":68,"phone":10,"phoneExt":10,"email":10},{"type":68,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Agnieszka Drozdowska-Szymczak","MD, PhD","100591747","cord-blood-s100b-protein-levels-in-neonates-following-intrauterine-transfusions-for-hdfn-associated-fetal-anemia-100591747",false,"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).","FEMALE","18 Years",{"count":123,"type":124},180,"ESTIMATED","OBSERVATIONAL","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.",[128,129,130,131],"s100b","Hypoxia-Ischemia, Brain","Hemolytic Disease of the Fetus and Newborn","Fetal Anemia",[133,134,135,136,137,138,139],"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":142,"type":143},"2025-05-22","ACTUAL",{"date":145,"type":143},"2024-07-17",{"date":147,"type":124},"2026-04-30",{"name":5,"class":6},1]