Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

Last updated: March 24, 2025
Sponsor: Institute of Mother and Child, Warsaw, Poland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Birth Defects

Treatment

Umbilical cord blood S100B protein level

Umbilical cord blood gas analysis

Prenatal ultrasound examination with blood flow analysis

Clinical Study ID

NCT06893926
S100BFGR
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Study Group - Inclusion Criteria:

  1. Women with a full-term pregnancy (≥37 weeks of gestation), singleton.

  2. Pregnancy complicated by FGR.

Exclusion

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 pregestationaldiabetes.

  • Maternal depression requiring pharmacological treatment (e.g., SSRIs).

  1. Intrapartum:

  • Factors indicating a possible intrauterine infection, such as amniotic fluidleakage for more than 15 hours, spontaneous preterm labor, diagnosedintrauterine 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, useof illicit stimulant substances, pregestational diabetes, or chronichypertension.

  • Maternal depression requiring pharmacological treatment (e.g., SSRIs).

  • Risk factors for intrauterine HI, including abnormal fetal blood flowparameters on ultrasound, abnormal CTG recordings, or the need for intrauterinetransfusion.

  1. Intrapartum:

  • Indicators of possible intrauterine infection, such as amniotic fluid leakagefor more than 15 hours, spontaneous preterm delivery, diagnosed intrauterineinfection, or maternal symptoms of infection.

  • Risk factors for perinatal HI.

  • Prolonged labor lasting more than 15 hours (counted from the onset of regularuterine 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.

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

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: Umbilical cord blood S100B protein level
Phase:
Study Start date:
June 18, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Institute of Mother and Child

    Warsaw, 01-211
    Poland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.