NCT06893926 Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction
| NCT ID | NCT06893926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Mother and Child, Warsaw, Poland |
| Condition | s100b |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-18 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-06-18 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Agnieszka A. Drozdowska-Szymczak, MD, PhD
PRINCIPAL INVESTIGATOR
Institute of Mother and Child in Warsaw, Poland
Frequently Asked Questions
Who can join the NCT06893926 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying s100b. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06893926 currently recruiting?
Yes, NCT06893926 is actively recruiting participants. Contact the research team at agnieszka.drozdowska@imid.med.pl for enrollment information.
Where is the NCT06893926 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06893926 clinical trial?
NCT06893926 is sponsored by Institute of Mother and Child, Warsaw, Poland. The principal investigator is Agnieszka A. Drozdowska-Szymczak, MD, PhD at Institute of Mother and Child in Warsaw, Poland. The trial plans to enroll 120 participants.