Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

Institute of Mother and Child, Warsaw, Poland

Status

Enrolling

Conditions

s100b

Fetal Growth Restriction (FGR)

Hypoxia-Ischemia, Brain

Treatments

Diagnostic Test: Neonatal transfontanelle ultrasound assessment

Diagnostic Test: Umbilical cord blood gas analysis

Diagnostic Test: Umbilical cord blood S100B protein level

Diagnostic Test: Prenatal ultrasound examination with blood flow analysis

Study type

Observational

Funder types

Other

Identifiers

NCT06893926

S100BFGR

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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