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

NCT06984445 | Recruiting

• 1 other identifier: S100BIUT
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• Cord blood S100B protein concentration

  Cord blood S100B protein concentration, measured both before the IUT in the study group and from umbilical cord blood samples collected after birth in both the study and control groups.

  Within 3 months of enrollment

Secondary Outcomes (3)

• Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis

  Within 3 months of enrollment

• Association between cord blood S100B protein concentration and complete blood count parameters

  Within 3 months of enrollment

• Correlation between cord blood S100B protein concentration and MCA-PSV values

  Within 3 months of enrollment

Study Arms (2)

Study group

Pregnant women with HDFN-related fetal anemia requiring intrauterine transfusion (IUT). The need for IUT is determined based on prenatal ultrasound assessment of the peak systolic velocity in the middle cerebral artery (MCA-PSV), expressed as multiples of the median (MoM). A MoM value greater than 1.5 is indicative of severe fetal anemia and serves as the primary criterion for IUT.

Diagnostic Test: Cord blood S100B protein level prior to IUT; Diagnostic Test: Umbilical cord blood gas analysis prior to IUT; Diagnostic Test: Fetal blood count evaluation prior to IUT; Diagnostic Test: Cord blood S100B protein concentration at birth; Diagnostic Test: Umbilical cord blood gas analysis at birth; Diagnostic Test: Complete blood count after birth; Diagnostic Test: Ultrasound evaluation of fetal blood flow; Diagnostic Test: Neonatal transfontanelle ultrasound assessment; Diagnostic Test: Complete blood count analysis in cord blood at birth

Control group

Women with pregnancies complicated by HDFN who do not meet the criteria for intrauterine transfusion (IUT).

Diagnostic Test: Cord blood S100B protein concentration at birth; Diagnostic Test: Umbilical cord blood gas analysis at birth; Diagnostic Test: Complete blood count after birth; Diagnostic Test: Ultrasound evaluation of fetal blood flow; Diagnostic Test: Neonatal transfontanelle ultrasound assessment; Diagnostic Test: Complete blood count analysis in cord blood at birth

Interventions

Cord blood S100B protein level prior to IUT DIAGNOSTIC_TEST

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.

Study group

Umbilical cord blood gas analysis prior to IUT DIAGNOSTIC_TEST

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.

Study group

Fetal blood count evaluation prior to IUT DIAGNOSTIC_TEST

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

Study group

Cord blood S100B protein concentration at birth DIAGNOSTIC_TEST

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.

Control group; Study group

Umbilical cord blood gas analysis at birth DIAGNOSTIC_TEST

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.

Control group; Study group

Complete blood count after birth DIAGNOSTIC_TEST

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

Control group; Study group

Ultrasound evaluation of fetal blood flow DIAGNOSTIC_TEST

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

Control group; Study group

Neonatal transfontanelle ultrasound assessment DIAGNOSTIC_TEST

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

Control group; Study group

Complete blood count analysis in cord blood at birth DIAGNOSTIC_TEST

Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured in cord blood samples collected at birth.

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women diagnosed with hemolytic disease of the fetus and newborn (HDFN).

You may qualify if:

• Singleton pregnancy.
• Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.
• Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.
• Fetal anemia requiring IUT, indicated by a MCA-PSV MoM value exceeding 1.5.

You may not qualify if:

• \. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).
• Singleton pregnancy.
• Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.
• Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.
• No indications for IUT, as determined by MCA-PSV MoM values \<1.5 in routine assessments of fetal cerebral arterial flow.
• \. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).

Sponsors & Collaborators

• Institute of Mother and Child, Warsaw, Poland: lead

Study Sites (1)

Institute of Mother and Child

Warsaw, 01-211, Poland

RECRUITING

Related Publications (30)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and whole blood samples

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Erythroblastosis, Fetal

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Immune System Diseases

Study Officials

• Agnieszka A. Drozdowska-Szymczak, MD, PhD

  Institute of Mother and Child in Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka A. Drozdowska-Szymczak, MD, PhD

CONTACT

+48 22 32 77 411; agnieszka.drozdowska@imid.med.pl

Sabina A. Łukawska, MD

CONTACT

+48 691 235 077; sabina.lukawska@imid.med.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: July 17, 2024
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

PL (1)