Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstitute of Mother and Child, Warsaw, Poland
About this trial
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
This trial does not accept healthy volunteersQualifiers
Women with a full-term pregnancy (≥37 weeks of gestation), singleton.
Pregnancy complicated by FGR.
Disqualifiers
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).
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.
Trial population
Women with a full-term pregnancy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prenatal ultrasound examination with blood flow analysis
Diagnostic testFor all patients who provide informed consent to participate in the study, an ultrasound examination is performed within 48 hours prior to delivery. This assessment includes: 1. Measurement of fetal anthropometric parameters and estimation of fetal weight. 2. Evaluation of blood flow using the pulsatility index (PI) in the UA, UtA, DV, and MCA.
Umbilical cord blood gas analysis
Diagnostic testA 0.5 mL blood sample is collected from the clamped section of the umbilical cord and immediately sent to the laboratory for cord blood gas analysis, including the determination of pH, base excess (BE), and lactate levels.
Umbilical cord blood S100B protein level
Diagnostic testA 1 mL sample of cord blood is collected in a labeled tube, which includes the mother's name, the child's gender, date of birth, and date of collection. The sample is then sent to the laboratory for centrifugation. The resulting serum samples are frozen, and once approximately 80 samples have been collected, they will be thawed and analyzed for S100B protein concentration. Any remaining material after laboratory processing will be properly disposed of.
Neonatal transfontanelle ultrasound assessment
Diagnostic testA transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Study group4 interventions
Group B: Control group4 interventions
Trial outcomes
Primary outcomes
1
Cord blood S100B protein concentration
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.
Time frame
Within 3 months of enrollmentSecondary outcomes
1
Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis
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.
Time frame
Within 3 months of enrollment2
Association between cord blood S100B protein concentration and fetal blood flow parameters
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.
Time frame
Within 3 months of enrollmentSponsors and contacts
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Source ClinicalTrials.gov