Evaluating the Utility of S100B Protein Concentration for Diagnosing Fetal Central Nervous System Hypoxia-Ischemia in Children With Late Fetal Growth Retardation: 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
- 120
- 试验地点
- 1
- 主要终点
- Cord blood S100B protein concentration
研究概览
简要总结
S100B protein is a biomarker that increases following central nervous system (CNS) damage. Measuring this protein's levels may allow for the early identification of infants at high risk for developmental abnormalities, such as fetal growth restriction (FGR), even on the first day of life, in a non-invasive manner. Early detection could enable timely interventions and rehabilitation, potentially improving the child's prognosis and long-term outcomes. This study investigates two groups of full-term pregnancies: a study group with prenatally diagnosed late FGR, and a control group with normal fetal growth. Following delivery, cord blood samples from both groups will be analyzed for S100B protein concentrations, pH, base excess (BE), and lactate levels. Additionally, fetal blood flow parameters in the umbilical artery (UA), uterine arteries (UtA), ductus venosus (DV), and middle cerebral artery (MCA) will be monitored via ultrasound within 48 hours before delivery. This study aims to compare S100B protein concentrations in umbilical cord blood between the two groups and to assess correlations with fetal Doppler parameters, pH, BE, and lactate levels in cord blood gas analysis. Ultimately, we seek to determine the effectiveness of S100B protein concentration as a biomarker for diagnosing fetal CNS hypoxia- ischemia in FGR-affected children, compared to those with normal growth.
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
- •Women with a full-term pregnancy (≥37 weeks of gestation), singleton.
- •Pregnancy complicated by FGR.
- •Study Group -
排除标准
- •Antenatal (at recruitment):
- •Maternal conditions that may affect the blood flow in placental vessels, including smoking, use of illicit stimulant substances, or pregestational diabetes.
- •Maternal depression requiring pharmacological treatment (e.g., SSRIs).
- •Intrapartum:
- •Factors indicating a possible intrauterine infection, such as amniotic fluid leakage for more than 15 hours, spontaneous preterm labor, diagnosed intrauterine infection, or symptoms of infection in the mother.
- •Prolonged labor lasting more than 15 hours.
- •Control Group - Inclusion Criteria:
- •Women with a full-term pregnancy (≥37 weeks of gestation), singleton.
- •Pregnancy not complicated by FGR.
- •Control Group - Exclusion Criteria:
- •Antenatal (at recruitment):
- •Maternal conditions that may affect placental blood flow, such as smoking, use of illicit stimulant substances, pregestational diabetes, or chronic hypertension.
- •Maternal depression requiring pharmacological treatment (e.g., SSRIs).
- •Risk factors for intrauterine HI, including abnormal fetal blood flow parameters on ultrasound, abnormal CTG recordings, or the need for intrauterine transfusion.
- •Intrapartum:
- •Indicators of possible intrauterine infection, such as amniotic fluid leakage for more than 15 hours, spontaneous preterm delivery, diagnosed intrauterine infection, or maternal symptoms of infection.
- •Risk factors for perinatal HI.
- •Prolonged labor lasting more than 15 hours (counted from the onset of regular uterine contractions).
- •Birth weight below the 10th percentile or above the 90th percentile.
- •Apgar score less than 8 at the 1st, 3rd, 5th, or 10th minute of life.
- •Abnormal umbilical cord blood gas analysis results, defined as pH < 7.15 or BE < -9.3 mmol/l.
- •Neonatal anemia requiring a top-up transfusion within the first 24 hours of life
结局指标
主要结局
Cord blood S100B protein concentration
时间窗: Within 3 months of enrollment
The study's primary endpoint will be the concentration of S100B protein measured from a cord blood sample taken 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)
- Association between cord blood S100B protein concentration and fetal blood flow parameters(Within 3 months of enrollment)
研究者
Agnieszka Drozdowska-Szymczak
MD, PhD
Institute of Mother and Child, Warsaw, Poland