Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

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

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.

Sponsors & Collaborators

• Institute of Mother and Child, Warsaw, Poland

  lead OTHER

Principal Investigators

• Agnieszka A. Drozdowska-Szymczak, MD, PhD · Institute of Mother and Child in Warsaw, Poland

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-18

Primary Completion

2025-12-31

Completion

2026-03-31

Countries

• Poland

Study Locations