Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

March 24, 2025 updated by: Agnieszka Drozdowska-Szymczak, Institute of Mother and Child, Warsaw, Poland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 01-211
        • Recruiting
        • Institute of Mother and Child
        • Contact:
        • Contact:
        • Principal Investigator:
          • Agnieszka A. Drozdowska-Szymczak, MD, PhD
        • Sub-Investigator:
          • Natalia Mazanowska, MD, PhD
        • Sub-Investigator:
          • Sabina A. Łukawska, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with a full-term pregnancy.

Description

Study Group - Inclusion Criteria:

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

Study Group - Exclusion Criteria:

  1. 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).

  2. 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:

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

Control Group - Exclusion Criteria:

  1. 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.

  2. 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.

  3. Postnatal:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 months of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 months of enrollment
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.
Within 3 months of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mother and Child, Warsaw, Poland

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S100BFGR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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