Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cord blood S100B protein level prior to IUT, Umbilical cord blood gas analysis prior to IUT, Fetal blood count evaluation prior to IUT, Cord blood S100B protein concentration at birth.
- Who it may be relevant to
- Registry conditions: s100b, Hypoxia-Ischemia, Brain, Hemolytic Disease of the Fetus and Newborn, Fetal Anemia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analysis of Cord Blood S100B Protein Levels in Neonates With Fetal Anemia Due to Hemolytic Disease Undergoing Intrauterine Transfusions: A Prospective Cohort Study
Overview
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.
Interventions
- Diagnostic test 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. - Diagnostic test 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. - Diagnostic test Fetal blood count evaluation prior to IUT
Fetal blood count data, including hemoglobin and hematocrit levels, will be collected before each IUT procedure. - Diagnostic test 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. - Diagnostic test 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. - Diagnostic test Complete blood count after birth
Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured within six hours after birth. - Diagnostic test Ultrasound evaluation of fetal blood flow
Fetal cerebral blood flow will be routinely assessed via ultrasound, including measurements of MCA-PSV values. - Diagnostic test Neonatal transfontanelle ultrasound assessment
A transfontanelle ultrasound examination will. be performed to assess for any abnormalities in the newborn. - Diagnostic test 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.
Primary outcome measures
- Cord blood S100B protein concentration [Time frame: Within 3 months of enrollment]
Secondary outcome measures (3)
- Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis [Time frame: Within 3 months of enrollment]
- Association between cord blood S100B protein concentration and complete blood count parameters [Time frame: Within 3 months of enrollment]
- Correlation between cord blood S100B protein concentration and MCA-PSV values [Time frame: Within 3 months of enrollment]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Institute of Mother and Child — Warsaw
Publications
- Ree IMC, Smits-Wintjens VEHJ, van der Bom JG, van Klink JMM, Oepkes D, Lopriore E. Neonatal management and outcome in alloimmune hemolytic disease. Expert Rev Hematol. 2017 Jul;10(7):607-616. doi: 10.1080/17474086.2017.1331124. Epub 2017 Jun 5. PMID 28503958
- Lindenburg IT, Smits-Wintjens VE, van Klink JM, Verduin E, van Kamp IL, Walther FJ, Schonewille H, Doxiadis II, Kanhai HH, van Lith JM, van Zwet EW, Oepkes D, Brand A, Lopriore E; LOTUS study group. Long-term neurodevelopmental outcome after intrauterine transfusion for hemolytic disease of the fetus/newborn: the LOTUS study. Am J Obstet Gynecol. 2012 Feb;206(2):141.e1-8. doi: 10.1016/j.ajog.2011. PMID 22030316
- Mazarico E, Llurba E, Cumplido R, Valls A, Melchor JC, Iglesias M, Cabero L, Gratacos E, Gomez-Roig MD. Neural injury markers in intrauterine growth restriction and their relation to perinatal outcomes. Pediatr Res. 2017 Sep;82(3):452-457. doi: 10.1038/pr.2017.108. Epub 2017 May 31. PMID 28426650
- Malhotra A, Ditchfield M, Fahey MC, Castillo-Melendez M, Allison BJ, Polglase GR, Wallace EM, Hodges R, Jenkin G, Miller SL. Detection and assessment of brain injury in the growth-restricted fetus and neonate. Pediatr Res. 2017 Aug;82(2):184-193. doi: 10.1038/pr.2017.37. Epub 2017 May 17. PMID 28234891
- Strzalko B, Karowicz-Bilinska A, Wyka K, Krajewski P, Kesiak M, Kociszewska-Najman B. Serum S100B Protein Concentrations in SGA/FGR newborns. Ginekol Pol. 2021 Jun 9. doi: 10.5603/GP.a2021.0119. Online ahead of print. PMID 34105746
- Zaigham M, Lundberg F, Olofsson P. Protein S100B in umbilical cord blood as a potential biomarker of hypoxic-ischemic encephalopathy in asphyxiated newborns. Early Hum Dev. 2017 Sep;112:48-53. doi: 10.1016/j.earlhumdev.2017.07.015. Epub 2017 Jul 27. PMID 28756088
- 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
Identifiers
NCT: NCT06984445 · S100BIUT