Measuring S100B Protein Levels in Newborns with Fetal Growth Restriction

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

This study is testing if measuring S100B protein levels in the cord blood of newborns with fetal growth restriction can help identify those at risk for developmental issues right after birth.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institute of Mother and Child, Warsaw, Poland (Academic / other)
• Locations: 1 site (Warsaw)
• Trial ID: NCT06893926 on ClinicalTrials.gov

What this trial studies

This observational study investigates the concentration of S100B protein in cord blood from newborns diagnosed with fetal growth restriction (FGR) compared to those with normal fetal growth. By analyzing cord blood samples for S100B protein levels, pH, base excess, and lactate, the study aims to identify infants at high risk for developmental abnormalities shortly after birth. Additionally, fetal blood flow parameters will be monitored via ultrasound before delivery to assess their correlation with S100B levels. The goal is to enable early detection and timely interventions for affected infants.

Who should consider this trial

Good fit: Ideal candidates include women with full-term singleton pregnancies complicated by fetal growth restriction.

Not a fit: Patients who are not full-term or have multiple pregnancies, as well as those with maternal conditions affecting blood flow, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early identification and management of infants at risk for developmental issues due to fetal growth restriction.

How similar studies have performed: While the approach of measuring S100B protein levels in newborns is promising, similar studies have shown varying results, indicating that this area is still being explored.

Eligibility criteria

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

Where this trial is running

Warsaw

• Institute of Mother and Child — Warsaw, Poland (Recruiting)

Study contacts

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

Conditions s100b; Hypoxia-Ischemia, Brain; Fetal Growth Restriction; S100B protein; fetal growth restriction; newborn; central nervous system damage; CNS hypoxia-ischemia