Actively Recruiting
Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction
Led by Institute of Mother and Child, Warsaw, Poland · Updated on 2025-03-25
120
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a full-term singleton pregnancy (at least 37 weeks gestation) in the study group must have fetal growth restriction (FGR).
- Women with a full-term singleton pregnancy (at least 37 weeks gestation) in the control group must have normal fetal growth without FGR.
You will not qualify if you...
- Maternal conditions affecting placental blood flow such as smoking, illicit stimulant use, or pregestational diabetes.
- Maternal depression requiring pharmacological treatment (e.g., SSRIs).
- Signs of possible intrauterine infection during labor, including amniotic fluid leakage longer than 15 hours, spontaneous preterm labor/delivery, diagnosed infection, or maternal infection symptoms.
- Labor lasting more than 15 hours from the start of regular uterine contractions.
- For control group: risk factors for intrauterine hypoxia-ischemia including abnormal fetal blood flow on ultrasound, abnormal CTG, or need for intrauterine transfusion.
- For control group: birth weight below the 10th percentile or above the 90th percentile.
- For control group: Apgar score less than 8 at 1, 3, 5, or 10 minutes after birth.
- For control group: abnormal umbilical cord blood gas with pH less than 7.15 or base excess less than -9.3 mmol/l.
- Postnatal neonatal anemia requiring transfusion within 24 hours of birth.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Mother and Child
Warsaw, Poland, 01-211
Actively Recruiting
Research Team
A
Agnieszka A. Drozdowska-Szymczak, MD, PhD
CONTACT
S
Sabina A. Łukawska, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here