Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

Recruiting

• Conditions: s100b; Hypoxia-Ischemia, Brain; Fetal Growth Restriction (FGR)

• Registration Number: NCT06893926
• Lead Sponsor: Institute of Mother and Child, Warsaw, Poland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-18
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cord blood S100B protein concentration	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis	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.
Association between cord blood S100B protein concentration and fetal blood flow parameters	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.

Trial Locations

Locations (1)

Institute of Mother and Child; 🇵🇱 Warsaw, Poland