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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест Cord blood S100B protein level prior to IUT
  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.
• Диагностический тест Umbilical cord blood gas analysis prior to IUT
  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.
• Диагностический тест Fetal blood count evaluation prior to IUT
  Fetal blood count data, including hemoglobin and hematocrit levels, will be collected before each IUT procedure.
• Диагностический тест Cord blood S100B protein concentration at birth
  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.
• Диагностический тест Umbilical cord blood gas analysis at birth
  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.
• Диагностический тест Complete blood count after birth
  Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured within six hours after birth.
• Диагностический тест Ultrasound evaluation of fetal blood flow
  Fetal cerebral blood flow will be routinely assessed via ultrasound, including measurements of MCA-PSV values.
• Диагностический тест Neonatal transfontanelle ultrasound assessment
  A transfontanelle ultrasound examination will. be performed to assess for any abnormalities in the newborn.
• Диагностический тест Complete blood count analysis in cord blood at birth
  Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured in cord blood samples collected at birth.

Первичные конечные точки

• Cord blood S100B protein concentration [Срок оценки: Within 3 months of enrollment]

Вторичные конечные точки (3)

• Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis [Срок оценки: Within 3 months of enrollment]
• Association between cord blood S100B protein concentration and complete blood count parameters [Срок оценки: Within 3 months of enrollment]
• Correlation between cord blood S100B protein concentration and MCA-PSV values [Срок оценки: Within 3 months of enrollment]

Критерии участия

Study Group - Inclusion Criteria:

• Singleton pregnancy.
• Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.
• Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.
• 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:

• Singleton pregnancy.
• Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.
• Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• Institute of Mother and Child — Warsaw

Публикации

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• Bouvier D, Giguere Y, Pereira B, Bernard N, Marc I, Sapin V, Forest JC. Cord blood S100B: reference ranges and interest for early identification of newborns with brain injury. Clin Chem Lab Med. 2020 Jan 28;58(2):285-293. doi: 10.1515/cclm-2019-0737. PMID 31622243
• Perrone S, Grassi F, Caporilli C, Boscarino G, Carbone G, Petrolini C, Gambini LM, Di Peri A, Moretti S, Buonocore G, Esposito SMR. Brain Damage in Preterm and Full-Term Neonates: Serum Biomarkers for the Early Diagnosis and Intervention. Antioxidants (Basel). 2023 Jan 29;12(2):309. doi: 10.3390/antiox12020309. PMID 36829868

Идентификаторы

NCT: NCT06984445 · S100BIUT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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