Measuring S100B Protein Levels in Newborns After Intrauterine Blood Transfusions for Fetal Anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the levels of S100B protein in the cord blood of newborns who have undergone intrauterine transfusions (IUT) due to hemolytic disease of the fetus and newborn (HDFN) associated with fetal anemia. It aims to determine whether S100B protein levels can predict the risk of central nervous system complications in these infants. The study will measure S100B protein concentrations before each IUT and at birth, alongside umbilical cord blood gas analysis and fetal blood count evaluations. The focus is on pregnancies with abnormal middle cerebral artery blood flow, indicating the need for IUT.

Why it matters

Who can join: the full rules

Study Group - Inclusion Criteria:

1. Singleton pregnancy.
2. Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.
3. Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.
4. Fetal anemia requiring IUT, indicated by a MCA-PSV MoM value exceeding 1.5.

Study Group - Exclusion Criteria:

1\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).

Control Group - Inclusion Criteria:

1. Singleton pregnancy.
2. Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.
3. Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.
4. No indications for IUT, as determined by MCA-PSV MoM values \<1.5 in routine assessments of fetal cerebral arterial flow.

Control Group - Exclusion Criteria:

1\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).

Where it's running

• Institute of Mother and Child
  Warsaw, Poland Recruiting

Study contacts

• Principal investigator: Agnieszka A. Drozdowska-Szymczak, MD, PhD — Institute of Mother and Child in Warsaw, Poland
• Study coordinator: Agnieszka A. Drozdowska-Szymczak, MD, PhD
• Email: agnieszka.drozdowska@imid.med.pl
• Phone: +48 22 32 77 411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.