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Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia

Recruitingn/aAges 18 Years - anyFemaleInstitute of Mother and Child, Warsaw, Poland
NCT06984445 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
Study Group - Inclusion Criteria: 1. Singleton pregnancy. 2. Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening. 3. Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow. 4. Fetal anemia requiring IUT, indicated by a MCA-PSV MoM value exceeding 1.5. Study Group - Exclusion Criteria: 1\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs). Control Group - Inclusion Criteria: 1. Singleton pregnancy. 2. Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening. 3. Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow. 4. No indications for IUT, as determined by MCA-PSV MoM values \<1.5 in routine assessments of fetal cerebral arterial flow. Control Group - Exclusion Criteria: 1\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).
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What it tests

  • Cord blood S100B protein level prior to IUT
  • Umbilical cord blood gas analysis prior to IUT
  • Fetal blood count evaluation prior to IUT
  • Cord blood S100B protein concentration at birth
  • Umbilical cord blood gas analysis at birth
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Where

1 site
Institute of Mother and Child
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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