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

Recruiting

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

• Registration Number: NCT06984445
• Lead Sponsor: Institute of Mother and Child, Warsaw, Poland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-17
• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-01-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cord blood S100B protein concentration	Within 3 months of enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis	Within 3 months of enrollment	The correlation between cord blood S100B protein concentration and pH, BE, and lactate levels, measured before the IUT in the study group and from umbilical cord blood samples collected after birth in both the study and control groups.
Correlation between cord blood S100B protein concentration and MCA-PSV values	Within 3 months of enrollment	The association between cord blood S100B protein concentration and MCA-PSV values determined via fetal ultrasound.
Association between cord blood S100B protein concentration and complete blood count parameters	Within 3 months of enrollment	The relationship between cord blood S100B protein concentration and Hgb and Hct levels, measured from cord blood samples collected before IUT in the study group, as well as from cord blood at birth and venous blood within the first six hours of life in both groups.

Trial Locations

Locations (1)

Institute of Mother and Child; 🇵🇱 Warsaw, Poland