Clinical trial NCT06984445: Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
Official title: Analysis of Cord Blood S100B Protein Levels in Neonates With Fetal Anemia Due to Hemolytic Disease Undergoing Intrauterine Transfusions: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: s100b
Hypoxia-Ischemia, Brain
Hemolytic Disease of the Fetus and Newborn
Fetal Anemia
Keywords: S100B protein
hemolytic disease of fetus and newborn (HDFN)
intrauterine transfusion (IUT)
fetal anemia
newborn
central nervous system (CNS) damage
CNS hypoxia-ischemia (HI)
Lead sponsor: Institute of Mother and Child, Warsaw, Poland
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women diagnosed with hemolytic disease of the fetus and newborn (HDFN).

Brief summary: 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.


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).

Primary outcomes:
measure: Cord blood S100B protein concentration
timeFrame: Within 3 months of enrollment
Secondary outcomes:
measure: Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis
timeFrame: Within 3 months of enrollment
measure: Association between cord blood S100B protein concentration and complete blood count parameters
timeFrame: Within 3 months of enrollment
measure: Correlation between cord blood S100B protein concentration and MCA-PSV values
timeFrame: Within 3 months of enrollment
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Mother and Child
Study officials:
affiliation: Institute of Mother and Child in Warsaw, Poland
name: Agnieszka A. Drozdowska-Szymczak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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