Clinical trial NCT06893926: Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: Institute of Mother and Child, Warsaw, Poland
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a full-term pregnancy.

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.


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

Primary outcomes:
measure: Cord blood S100B protein concentration
timeFrame: Within 3 months of enrollment
Secondary outcomes:
measure: Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis
timeFrame: Within 3 months of enrollment
measure: Association between cord blood S100B protein concentration and fetal blood flow parameters
timeFrame: Within 3 months of enrollment
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Mother and Child
Study officials:
affiliation: Institute of Mother and Child in Warsaw, Poland
name: Agnieszka A. Drozdowska-Szymczak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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