Actively Recruiting

Age: 18Years +
FEMALE
ID06984445

Analysis of Cord Blood S100B Protein Levels in Neonates With Fetal Anemia Due to Hemolytic Disease Undergoing Intrauterine Transfusions: A Prospective Cohort Study

Led by Institute of Mother and Child, Warsaw, Poland · Updated on 2025-05-22

180

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the levels of the S100B protein in newborns with fetal anemia caused by hemolytic disease of the fetus and newborn (HDFN). This condition often requires intrauterine transfusions (IUTs), which carry a risk of central nervous system damage. The study aims to understand if measuring S100B protein before IUT can predict which fetuses are at higher risk for brain complications and how these levels relate to anemia severity and fetal blood flow. The study includes two groups: pregnant women with HDFN-related fetal anemia needing IUT, determined by abnormal middle cerebral artery peak systolic velocity (MCA-PSV) above 1.5 multiples of the median, and women with HDFN pregnancies that do not require IUT. Blood samples will be collected before each IUT and at birth to measure S100B protein, blood gas values, and blood count parameters. Fetal cerebral blood flow will be monitored by ultrasound, and newborns will have a transfontanelle ultrasound to check for brain abnormalities. Participants will undergo routine ultrasound assessments and blood sampling before IUT procedures and at delivery. Researchers will analyze S100B protein levels in cord blood, examine correlations with blood gas and blood count parameters, and evaluate fetal cerebral blood flow measurements. The primary outcome is S100B protein concentration in cord blood, with secondary outcomes exploring its relationships to various blood and flow measurements. The study follows participants from prenatal diagnosis through birth, with all tests completed within three months of enrollment.

CONDITIONS

Brief Title

Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with a singleton pregnancy
  • Diagnosis of hemolytic disease of the fetus and newborn confirmed by maternal blood screening for alloantibodies
  • Complete medical records including routine ultrasound assessments of fetal middle cerebral artery blood flow
  • For study group: fetal anemia requiring intrauterine transfusion indicated by MCA-PSV MoM value greater than 1.5
  • For control group: no indications for intrauterine transfusion with MCA-PSV MoM values less than 1.5
Not Eligible

You will not qualify if you...

  • Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs)

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 delivery

Participants undergo diagnostic tests including ultrasound evaluations of fetal blood flow and measurements of fetal blood counts, as well as cord blood sampling before and at birth to assess protein levels, blood gases, and complete blood counts.

Multiple assessments before and at birth depending on the need for intrauterine transfusions

Long-term Monitoring

Duration - Within 3 months of enrollment

Participants are observed after birth with neonatal transfontanelle ultrasound assessments and laboratory tests to monitor cord blood protein concentrations and blood parameters.

Follow-up visits as needed within 3 months post-delivery

Trial Site Locations

Total: 1 location

1

Institute of Mother and Child

Warsaw, Poland, 01-211

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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

Long-term neurodevelopmental outcome after intrauterine transfusion for hemolytic disease of the fetus/newborn: the LOTUS study.

Irene T Lindenburg, Vivianne E Smits-Wintjens, Jeanine M van Klink...

https://pubmed.ncbi.nlm.nih.gov/22030316

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

The calcium binding protein, S100B, is increased in the amniotic fluid of women with intra-amniotic infection/inflammation and preterm labor with intact or ruptured membranes.

Lara A Friel, Roberto Romero, Sam Edwin...

https://pubmed.ncbi.nlm.nih.gov/17624933