NCT06893926

Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Institute of Mother and Child, Warsaw, Poland · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• s100b
• Hypoxia-Ischemia, Brain
• Fetal Growth Restriction (FGR)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Prenatal ultrasound examination with blood flow analysis	For all patients who provide informed consent to participate in the study, an ultrasound examination is performed within 48 hours prior to delivery. This assessment includes: 1. Measurement of fetal anthropometric parameters and estimation of fetal weight. 2. Evaluation of blood flow using the pulsatility index (PI) in the UA, UtA, DV, and MCA.
DIAGNOSTIC_TEST	Umbilical cord blood gas analysis	A 0.5 mL blood sample is collected from the clamped section of the umbilical cord and immediately sent to the laboratory for cord blood gas analysis, including the determination of pH, base excess (BE), and lactate levels.
DIAGNOSTIC_TEST	Umbilical cord blood S100B protein level	A 1 mL sample of cord blood is collected in a labeled tube, which includes the mother's name, the child's gender, date of birth, and date of collection. The sample is then sent to the laboratory for centrifugation. The resulting serum samples are frozen, and once approximately 80 samples have been collected, they will be thawed and analyzed for S100B protein concentration. Any remaining material after laboratory processing will be properly disposed of.
DIAGNOSTIC_TEST	Neonatal transfontanelle ultrasound assessment	A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.

Timeline

• Start date: 2024-06-18
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: Poland