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NCT Number: NCT06893926

Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

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.

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Key information

Conditions

s100b Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Restriction (FGR) Fetal Growth Retardation Growth Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institute of Mother and Child

Warsaw, 01-211, Poland

Location status: Recruiting

Location contact

Agnieszka A. Drozdowska-Szymczak, MD, PhD

CONTACT

[email protected]

+48 22 32 77 411

Agnieszka A. Drozdowska-Szymczak, MD, PhD

PRINCIPAL_INVESTIGATOR

Natalia Mazanowska, MD, PhD

SUB_INVESTIGATOR

Sabina A. Łukawska, MD

CONTACT

[email protected]

+48 691 235 077

Sabina A. Łukawska, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Study Group - Inclusion Criteria:

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

Study Group - Exclusion Criteria:

  • 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.
  • Postnatal:
  • Neonatal anemia requiring a top-up transfusion within the first 24 hours of life

Treatment and study plan

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:

  • Measurement of fetal anthropometric parameters and estimation of fetal weight.
  • Evaluation of blood flow using the pulsatility index (PI) in the UA, UtA, DV, and MCA.

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.

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.

Neonatal transfontanelle ultrasound assessment

Diagnostic Test

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

Primary outcomes

  1. Cord blood S100B protein concentration

    Time frame: 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.

Secondary outcomes

  1. Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis

    Time frame: Within 3 months of enrollment

    The potential correlation between cord blood S100B concentration and pH, BE, and lactate levels, as determined by cord blood gas analysis, in both the study and control groups.

  2. Association between cord blood S100B protein concentration and fetal blood flow parameters

    Time frame: Within 3 months of enrollment

    The potential relationship between cord blood S100B protein concentration and blood flow parameters (PI) in the UA, UtA, DV, and MCA, as assessed by fetal ultrasound performed within 48 hours before delivery.

Study contacts

Contact information is provided by the study sponsor or research team.

Agnieszka A. Drozdowska-Szymczak, MD, PhD

CONTACT

[email protected]

+48 22 32 77 411

Sabina A. Łukawska, MD

CONTACT

[email protected]

+48 691 235 077

Sponsors and collaborators

Lead sponsor

Institute of Mother and Child, Warsaw, Poland

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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