Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

NCT06893926 | Recruiting

• 1 other identifier: S100BFGR
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

S100B protein; fetal growth restriction (FGR); newborn; central nervous system (CNS) damage; CNS hypoxia-ischemia (HI)

Outcome Measures

Primary Outcomes (1)

• Cord blood S100B protein concentration

  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.

  Within 3 months of enrollment

Secondary Outcomes (2)

• 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

Study Arms (2)

Study group

Women with a full-term pregnancy and a prenatal diagnosis of late-onset FGR.

Diagnostic Test: Prenatal ultrasound examination with blood flow analysis; Diagnostic Test: Umbilical cord blood gas analysis; Diagnostic Test: Umbilical cord blood S100B protein level; Diagnostic Test: Neonatal transfontanelle ultrasound assessment

Control group

Women with a full-term pregnancy and normal fetal development.

Diagnostic Test: Prenatal ultrasound examination with blood flow analysis; Diagnostic Test: Umbilical cord blood gas analysis; Diagnostic Test: Umbilical cord blood S100B protein level; Diagnostic Test: Neonatal transfontanelle ultrasound assessment

Interventions

Prenatal ultrasound examination with blood flow analysis DIAGNOSTIC_TEST

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.

Control group; Study group

Umbilical cord blood gas analysis DIAGNOSTIC_TEST

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.

Control group; Study group

Umbilical cord blood S100B protein level DIAGNOSTIC_TEST

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.

Control group; Study group

Neonatal transfontanelle ultrasound assessment DIAGNOSTIC_TEST

A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with a full-term pregnancy.

You may qualify if:

• Women with a full-term pregnancy (≥37 weeks of gestation), singleton.
• Pregnancy complicated by FGR.

You may not qualify if:

• 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.
• Women with a full-term pregnancy (≥37 weeks of gestation), singleton.
• Pregnancy not complicated by FGR.
• 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.

Sponsors & Collaborators

• Institute of Mother and Child, Warsaw, Poland: lead

Study Sites (1)

Institute of Mother and Child

Warsaw, 01-211, Poland

RECRUITING

Related Publications (25)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and whole blood samples

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes

Study Officials

• Agnieszka A. Drozdowska-Szymczak, MD, PhD

  Institute of Mother and Child in Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka A. Drozdowska-Szymczak, MD, PhD

CONTACT

+48 22 32 77 411; agnieszka.drozdowska@imid.med.pl

Sabina A. Łukawska, MD

CONTACT

+48 691 235 077; sabina.lukawska@imid.med.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 25, 2025
• Study Start: June 18, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

PL (1)