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

Institute of Mother and Child, Warsaw, Poland

Status

Enrolling

Conditions

Fetal Anemia

s100b

Hemolytic Disease of the Fetus and Newborn

Hypoxia-Ischemia, Brain

Treatments

Diagnostic Test: Cord blood S100B protein concentration at birth

Diagnostic Test: Fetal blood count evaluation prior to IUT

Diagnostic Test: Complete blood count after birth

Diagnostic Test: Umbilical cord blood gas analysis at birth

Diagnostic Test: Umbilical cord blood gas analysis prior to IUT

Diagnostic Test: Complete blood count analysis in cord blood at birth

Diagnostic Test: Cord blood S100B protein level prior to IUT

Diagnostic Test: Ultrasound evaluation of fetal blood flow

Diagnostic Test: Neonatal transfontanelle ultrasound assessment

Study type

Observational

Funder types

Other

Identifiers

NCT06984445

S100BIUT

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Study Group - Inclusion Criteria:

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.

Study Group - Exclusion Criteria:

Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).

Control Group - Inclusion Criteria:

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.

Control Group - Exclusion Criteria:

Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).

Trial design

180 participants in 2 patient groups

Study group

Description:

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.

Treatment: