An observational study in s100b, Hypoxia-Ischemia, Brain and Hemolytic Disease of the Fetus and Newborn, sponsored by Institute of Mother and Child, Warsaw, Poland. Recruiting at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Institute of Mother and Child, Warsaw, Poland · Observational
levated levels of S100B protein are a well-established marker of central nervous system (CNS) damage. Fetal anemia resulting from hemolytic disease of the fetus and newborn (HDFN) often necessitates intrauterine transfusions (IUTs) and represents a significant risk factor for CNS injury. However, it remains uncertain whether S100B protein levels can reliably predict which fetuses are at higher risk for CNS complications in this context. Furthermore, the potential role of measuring S100B concentrations before IUT in prenatal assessments, and its relationship to the severity of anemia and fetal cerebral blood flow, remains poorly understood. This study aims to investigate the concentration of S100B protein in cord blood from newborns with HDFN-related fetal anemia requiring IUT. The study group comprises pregnancies complicated by HDFN with abnormal middle cerebral artery (MCA) blood flow, indicating the need for IUT. In this group, S100B protein levels will be measured before each IUT, with additional measurements if further transfusions are required. The control group consists of pregnancies with HDFN that do not require IUT. Cord blood samples will be collected at birth to evaluate S100B protein levels in both groups. Additionally, fetal MCA blood flow will be monitored, and in the study group, fetal hemoglobin and hematocrit levels will be assessed before each IUT. The primary endpoints of the study include the measurement of cord blood S100B protein levels before IUT in the study group and at birth in both groups. Secondary endpoints will explore the potential correlations between S100B protein levels and umbilical cord blood gas parameters (e.g., pH, BE, lactate), fetal cerebral blood flow parameters (e.g., MCA-PSV values), and blood count parameters (e.g., hemoglobin and hematocrit levels), both before IUT in the study group and after birth in both groups.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's planned enrollment of 180 is above the median of 100 across 92 observational studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Institute of Mother and Child, Warsaw, Poland is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women diagnosed with hemolytic disease of the fetus and newborn (HDFN).
Study Group - Inclusion Criteria:
Study Group - Exclusion Criteria:
Control Group - Inclusion Criteria:
Control Group - Exclusion Criteria:
Pregnant women with HDFN-related fetal anemia requiring intrauterine transfusion (IUT). The need for IUT is determined based on prenatal ultrasound assessment of the peak systolic velocity in the middle cerebral artery (MCA-PSV), expressed as multiples of the median (MoM). A MoM value greater than 1.5 is indicative of severe fetal anemia and serves as the primary criterion for IUT.
Diagnostic Test: Cord blood S100B protein level prior to IUT · Diagnostic Test: Umbilical cord blood gas analysis prior to IUT · Diagnostic Test: Fetal blood count evaluation prior to IUT · Diagnostic Test: Cord blood S100B protein concentration at birth · Diagnostic Test: Umbilical cord blood gas analysis at birth · Diagnostic Test: Complete blood count after birth · Diagnostic Test: Ultrasound evaluation of fetal blood flow · Diagnostic Test: Neonatal transfontanelle ultrasound assessment · Diagnostic Test: Complete blood count analysis in cord blood at birth
Women with pregnancies complicated by HDFN who do not meet the criteria for intrauterine transfusion (IUT).
Diagnostic Test: Cord blood S100B protein concentration at birth · Diagnostic Test: Umbilical cord blood gas analysis at birth · Diagnostic Test: Complete blood count after birth · Diagnostic Test: Ultrasound evaluation of fetal blood flow · Diagnostic Test: Neonatal transfontanelle ultrasound assessment · Diagnostic Test: Complete blood count analysis in cord blood at birth
One milliliter of cord blood will be collected before each IUT procedure to measure S100B protein concentration. The sample will be labeled with the mother's name, date of birth, collection date, and IUT indication, then sent to the laboratory for centrifugation.
Half a milliliter of cord blood will be collected before each IUT procedure for immediate umbilical cord blood gas analysis, including pH, base excess (BE), and lactate levels.
Fetal blood count data, including hemoglobin and hematocrit levels, will be collected before each IUT procedure.
After delivery, one milliliter of blood will be collected from the severed umbilical cord to measure the concentration of S100B protein. The sample will be labeled with the mother's name, the child's birth date and sex, and the collection date, before being sent to the laboratory for centrifugation.
After birth, 0.5 mL of blood will be collected from the severed umbilical cord to assess pH, base excess (BE), and lactate levels in an umbilical cord blood gas analysis.
Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured within six hours after birth.
Fetal cerebral blood flow will be routinely assessed via ultrasound, including measurements of MCA-PSV values.
A transfontanelle ultrasound examination will. be performed to assess for any abnormalities in the newborn.
Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured in cord blood samples collected at birth.
Cord blood S100B protein concentration
Cord blood S100B protein concentration, measured both before the IUT in the study group and from umbilical cord blood samples collected after birth in both the study and control groups.
Time frame: Within 3 months of enrollment
Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis
The correlation between cord blood S100B protein concentration and pH, BE, and lactate levels, measured before the IUT in the study group and from umbilical cord blood samples collected after birth in both the study and control groups.
Time frame: Within 3 months of enrollment
Association between cord blood S100B protein concentration and complete blood count parameters
The relationship between cord blood S100B protein concentration and Hgb and Hct levels, measured from cord blood samples collected before IUT in the study group, as well as from cord blood at birth and venous blood within the first six hours of life in both groups.
Time frame: Within 3 months of enrollment
Correlation between cord blood S100B protein concentration and MCA-PSV values
The association between cord blood S100B protein concentration and MCA-PSV values determined via fetal ultrasound.
Time frame: Within 3 months of enrollment
Plan to share: Undecided
Started Jul 2024 (actual). Primary completion is estimated for Jan 2026, 18 months after the start.
Of 47 non-industry observational studies under Hypoxia-Ischemia, Brain, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20. This study's planned 18 months is below that.
Counting every sponsor, half of 51 studies reached it within 43 months; a quarter within 20.
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Institute of Mother and Child, Warsaw, Poland