Actively Recruiting

Age: 18Years +
FEMALE
ID06893926

Evaluating S100B Protein Levels to Diagnose Brain Oxygen Deprivation in Newborns With Late Fetal Growth Restriction: A Prospective Cohort Study

Led by Institute of Mother and Child, Warsaw, Poland · Updated on 2025-03-25

120

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of S100B protein levels as a biomarker to detect early brain damage in newborns affected by fetal growth restriction (FGR). The study compares two groups of full-term pregnancies: one group with late-onset FGR diagnosed before birth and a control group with normal fetal growth. The goal is to understand if measuring S100B in cord blood can help identify infants at risk for developmental problems related to brain hypoxia-ischemia. The study involves prenatal ultrasound exams within 48 hours before delivery to assess fetal blood flow in several arteries. After birth, cord blood samples are collected to measure S100B protein levels, pH, base excess, and lactate. Additionally, newborns undergo a transfontanelle ultrasound to check for abnormalities. Samples are processed and analyzed to compare the two groups and assess relationships between protein levels and other blood and ultrasound markers. Participants will provide cord blood and ultrasound data shortly before and after delivery. Researchers will analyze S100B concentrations and their correlation with blood gas values and fetal blood flow parameters. The main outcome is the S100B level in cord blood within three months of enrollment. This observational study helps understand the potential of S100B as a diagnostic marker for brain oxygen deprivation in babies with FGR.

CONDITIONS

Brief Title

Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with a full-term pregnancy (at least 37 weeks gestation), singleton pregnancy
  • Pregnancy complicated by fetal growth restriction for the study group
  • Pregnancy not complicated by fetal growth restriction for the control group
Not Eligible

You will not qualify if you...

  • Maternal smoking, use of illicit stimulant substances, or pregestational diabetes
  • Maternal depression requiring pharmacological treatment such as SSRIs
  • Signs of possible intrauterine infection or spontaneous preterm labor
  • Prolonged labor lasting more than 15 hours
  • Risk factors for intrauterine hypoxia-ischemia, including abnormal fetal blood flow or abnormal CTG
  • Birth weight below 10th or above 90th percentile for control group
  • Apgar score below 8 at 1st, 3rd, 5th, or 10th minute of life
  • Abnormal umbilical cord blood gas analysis results (pH < 7.15 or base excess < -9.3 mmol/l)
  • Neonatal anemia requiring transfusion within first 24 hours of life for control group
  • Chronic hypertension in mother for control group
  • Diagnosed intrauterine infection or maternal symptoms of infection
  • Spontaneous preterm delivery for control group
  • Risk factors for perinatal hypoxia-ischemia for control group
  • Prolonged labor counted from regular uterine contractions for control group (more than 15 hours)

Note: Exclusion criteria vary slightly between study and control groups as detailed above, focusing on conditions affecting placental blood flow and fetal health status at birth and during pregnancy or labor. Please review eligibility criteria for precise details on exclusions per group.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to birth and immediately after delivery

Participants undergo prenatal ultrasound examination with blood flow analysis within 48 hours prior to delivery, followed by collection of umbilical cord blood samples at birth for gas analysis and S100B protein level measurement. A neonatal transfontanelle ultrasound assessment is also performed to check for abnormalities.

1 prenatal ultrasound visit and 1 birth visit for cord blood collection and neonatal ultrasound

Long-term Monitoring

Duration - Up to 3 months after enrollment

Participants are observed to assess cord blood S100B protein concentration and its correlation with other clinical parameters within 3 months after enrollment.

Follow-up assessments as part of routine clinical care

Trial Site Locations

Total: 1 location

1

Institute of Mother and Child

Warsaw, Poland, 01-211

Actively Recruiting

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Research Team

A

Agnieszka A. Drozdowska-Szymczak, MD, PhD

S

Sabina A. Łukawska, MD

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

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Published Research Related To This Trial

Protein S100B in umbilical cord blood as a potential biomarker of hypoxic-ischemic encephalopathy in asphyxiated newborns.

Mehreen Zaigham, Fredrik Lundberg, Per Olofsson

https://pubmed.ncbi.nlm.nih.gov/28756088

Brain Damage in Preterm and Full-Term Neonates: Serum Biomarkers for the Early Diagnosis and Intervention.

Serafina Perrone, Federica Grassi, Chiara Caporilli...

https://pubmed.ncbi.nlm.nih.gov/36829868