Measuring S100B Protein Levels in Newborns After Intrauterine Blood Transfusions for 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

This study is testing if measuring a specific protein in the blood of newborns who received blood transfusions before birth can help predict the risk of brain problems later on.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institute of Mother and Child, Warsaw, Poland (Academic / other)
• Locations: 1 site (Warsaw)
• Trial ID: NCT06984445 on ClinicalTrials.gov

What this trial studies

This observational study investigates the levels of S100B protein in the cord blood of newborns who have undergone intrauterine transfusions (IUT) due to hemolytic disease of the fetus and newborn (HDFN) associated with fetal anemia. It aims to determine whether S100B protein levels can predict the risk of central nervous system complications in these infants. The study will measure S100B protein concentrations before each IUT and at birth, alongside umbilical cord blood gas analysis and fetal blood count evaluations. The focus is on pregnancies with abnormal middle cerebral artery blood flow, indicating the need for IUT.

Who should consider this trial

Good fit: Ideal candidates include singleton pregnancies diagnosed with HDFN requiring intrauterine transfusions, confirmed by maternal blood screening and abnormal fetal blood flow assessments.

Not a fit: Patients who do not require intrauterine transfusions or have maternal chronic use of SSRIs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify fetuses at higher risk for CNS complications, potentially improving prenatal care and outcomes for affected newborns.

How similar studies have performed: While the approach of measuring S100B protein levels in this context is novel, similar studies have explored biomarkers for CNS injury in other settings.

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).

Where this trial is running

Warsaw

• Institute of Mother and Child — Warsaw, Poland (Recruiting)

Study contacts

• Principal investigator: Agnieszka A. Drozdowska-Szymczak, MD, PhD — Institute of Mother and Child in Warsaw, Poland
• Study coordinator: Agnieszka A. Drozdowska-Szymczak, MD, PhD

Conditions s100b; Hypoxia-Ischemia, Brain; Hemolytic Disease of the Fetus and Newborn; Fetal Anemia; S100B protein; hemolytic disease of fetus and newborn; intrauterine transfusion; fetal anemia