Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
Launched by INSTITUTE OF MOTHER AND CHILD, WARSAW, POLAND · May 14, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the levels of a protein called S100B in cord blood from newborns who have a condition known as hemolytic disease of the fetus and newborn (HDFN), which can lead to fetal anemia. This study focuses on babies who require intrauterine transfusions (IUTs) because of severe anemia, as these situations might put them at risk for brain injury. Researchers want to see if measuring S100B levels before the transfusions can help predict which babies are more likely to experience complications related to their brain.
To participate in this trial, mothers must be pregnant with a single baby and have a confirmed diagnosis of HDFN. They should also have medical records and ultrasound results showing the need for an intrauterine transfusion due to severe fetal anemia. Participants in the study group will have their S100B levels measured before each transfusion, and both groups will have samples taken at birth to compare results. This study aims to improve our understanding of fetal anemia and its effects on newborns, which could help guide better care for affected families.
Gender
FEMALE
Eligibility criteria
- 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).
About Institute Of Mother And Child, Warsaw, Poland
The Institute of Mother and Child, located in Warsaw, Poland, is a leading research and clinical institution dedicated to improving maternal and child health outcomes. With a strong emphasis on innovative medical research, the institute conducts a wide range of clinical trials aimed at advancing pediatric and obstetric care. Its multidisciplinary team of experts collaborates closely with healthcare professionals and academic institutions to ensure the highest standards of scientific rigor and ethical integrity in all studies. By fostering a collaborative environment, the Institute of Mother and Child strives to translate research findings into effective clinical practices that enhance the well-being of mothers and children both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warsaw, , Poland
Patients applied
Trial Officials
Agnieszka A. Drozdowska-Szymczak, MD, PhD
Principal Investigator
Institute of Mother and Child in Warsaw, Poland
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported