New markers of neonatal neurology.
Diego Gazzolo, Raul Abella, Emanuela Marinoni...
https://pubmed.ncbi.nlm.nih.gov/19718579/Actively Recruiting
Led by Institute of Mother and Child, Warsaw, Poland · Updated on 2025-05-22
180
Participants Needed
1
Research Sites
12 weeks
Total Duration
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
Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
A
Agnieszka A. Drozdowska-Szymczak, MD, PhD
S
Sabina A. Łukawska, MD
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Institute of Mother and Child, Warsaw, Poland
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/28234891/Institute of Mother and Child, Warsaw, Poland
Lead Sponsor