Analysis of Cord Blood S100B Protein Levels in Neonates With Fetal Anemia Due to Hemolytic Disease Undergoing Intrauterine Transfusions: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Cord blood S100B protein concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Study Group -
排除标准
- •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).
结局指标
主要结局
Cord blood S100B protein concentration
时间窗: 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.
次要结局
- Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis(Within 3 months of enrollment)
- Correlation between cord blood S100B protein concentration and MCA-PSV values(Within 3 months of enrollment)
- Association between cord blood S100B protein concentration and complete blood count parameters(Within 3 months of enrollment)
研究者
Agnieszka Drozdowska-Szymczak
MD, PhD
Institute of Mother and Child, Warsaw, Poland