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

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.

Conditions

• s100b
• Hypoxia-Ischemia, Brain
• Hemolytic Disease of the Fetus and Newborn
• Fetal Anemia

Interventions

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Fetal blood count evaluation prior to IUT

Fetal blood count data, including hemoglobin and hematocrit levels, will be collected before each IUT procedure.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Complete blood count after birth

Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured within six hours after birth.

DIAGNOSTIC_TEST

Ultrasound evaluation of fetal blood flow

Fetal cerebral blood flow will be routinely assessed via ultrasound, including measurements of MCA-PSV values.

DIAGNOSTIC_TEST

Neonatal transfontanelle ultrasound assessment

A transfontanelle ultrasound examination will. be performed to assess for any abnormalities in the newborn.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• Institute of Mother and Child, Warsaw, Poland

  lead OTHER

Principal Investigators

• Agnieszka A. Drozdowska-Szymczak, MD, PhD · Institute of Mother and Child in Warsaw, Poland

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-17

Primary Completion

2026-01-31

Completion

2026-04-30

Countries

• Poland

Study Locations