s100bNCT06984445
Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
An observational study of s100b and Hypoxia-Ischemia, Brain, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- s100b, Hypoxia-Ischemia, Brain, Hemolytic Disease of the Fetus and Newborn
- What is being tested?
- Cord blood S100B protein level prior to IUT, Umbilical cord blood gas analysis prior to IUT and Fetal blood count evaluation prior to IUT
- How many people
- 180 participants
- Where
- 1 sitePoland
- Study dates
- 17 Jul 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women diagnosed with hemolytic disease of the fetus and newborn (HDFN).
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:
- 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:
- Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Institute of Mother and Child
Warsaw, 01-211
Agnieszka A. Drozdowska-Szymczak, MD, PhD, +48 22 32 77 411, agnieszka.drozdowska@imid.med.pl
Sabina A. Łukawska, MD, +48 691 235 077, sabina.lukawska@imid.med.pl
About this study
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
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.
- Being tested
- 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, Umbilical cord blood gas analysis at birth
- Keywords
- S100B protein, hemolytic disease of fetus and newborn (HDFN), intrauterine transfusion (IUT), fetal anemia, newborn, central nervous system (CNS) damage, CNS hypoxia-ischemia (HI)
- Medical subject headings
- Hypoxia-Ischemia, Brain, Erythroblastosis, Fetal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord blood S100B protein level prior to IUTDiagnostic test
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.
Umbilical cord blood gas analysis prior to IUTDiagnostic test
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 evaluation prior to IUTDiagnostic test
Fetal blood count data, including hemoglobin and hematocrit levels, will be collected before each IUT procedure.
Cord blood S100B protein concentration at birthDiagnostic test
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.
Umbilical cord blood gas analysis at birthDiagnostic test
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 after birthDiagnostic test
Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured within six hours after birth.
Ultrasound evaluation of fetal blood flowDiagnostic test
Fetal cerebral blood flow will be routinely assessed via ultrasound, including measurements of MCA-PSV values.
Neonatal transfontanelle ultrasound assessmentDiagnostic test
A transfontanelle ultrasound examination will. be performed to assess for any abnormalities in the newborn.
Complete blood count analysis in cord blood at birthDiagnostic test
Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured in cord blood samples collected at birth.
| Study group | Role | What they receive |
|---|---|---|
| Study group | 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. Receives: 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 | |
| Control group | Women with pregnancies complicated by HDFN who do not meet the criteria for intrauterine transfusion (IUT). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months of enrollment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Within 3 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start17 Jul 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for s100bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mother and Child, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Drozdowska-Szymczak, Institute of Mother and Child, Warsaw, Poland
- Investigators
- Agnieszka A. Drozdowska-Szymczak, MD, PhD, Principal investigator, Institute of Mother and Child in Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984445
- Sponsor's protocol ID
- S100BIUT
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28503958Lindenburg 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.2011.09.024. Epub 2011 Sep 24.
PubMed 22030316Mazarico 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.
PubMed 28426650Malhotra 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.
PubMed 28234891Strzalko 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.
PubMed 34105746Zaigham 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.
PubMed 28756088Bouvier 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.
PubMed 31622243Perrone 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.
PubMed 36829868Friel LA, Romero R, Edwin S, Nien JK, Gomez R, Chaiworapongsa T, Kusanovic JP, Tolosa JE, Hassan SS, Espinoza J. The calcium binding protein, S100B, is increased in the amniotic fluid of women with intra-amniotic infection/inflammation and preterm labor with intact or ruptured membranes. J Perinat Med. 2007;35(5):385-93. doi: 10.1515/JPM.2007.101.
PubMed 17624933Pawluski JL, Galea LA, Brain U, Papsdorf M, Oberlander TF. Neonatal S100B protein levels after prenatal exposure to selective serotonin reuptake inhibitors. Pediatrics. 2009 Oct;124(4):e662-70. doi: 10.1542/peds.2009-0442. Epub 2009 Sep 28.
PubMed 19786426Lu H, Huang W, Chen X, Wang Q, Zhang Q, Chang M. Relationship between premature brain injury and multiple biomarkers in cord blood and amniotic fluid. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2898-2904. doi: 10.1080/14767058.2017.1359532. Epub 2017 Aug 3.
PubMed 28738706Chiang LM, Chen WY, Yang YC, Jeng MJ. Elevation of serum S100 protein concentration as a marker of ischemic brain damage in extremely preterm infants. J Chin Med Assoc. 2015 Oct;78(10):610-6. doi: 10.1016/j.jcma.2015.06.009. Epub 2015 Aug 15.
PubMed 26285828Florio P, Abella R, Marinoni E, Di Iorio R, Li Volti G, Galvano F, Pongiglione G, Frigiola A, Pinzauti S, Petraglia F, Gazzolo D. Biochemical markers of perinatal brain damage. Front Biosci (Schol Ed). 2010 Jan 1;2(1):47-72. doi: 10.2741/s45.
PubMed 20036928Huang RZ, Zhang YJ, Zhang JF, Su YM, Peng LQ, Ya N. Relation between prognosis and changes of MBP and S100B in premature infants with periventricular leukomalacia. Genet Mol Res. 2015 Apr 30;14(2):4338-43. doi: 10.4238/2015.April.30.6.
PubMed 25966206Niwa Y, Imai K, Kotani T, Miki R, Nakano T, Ushida T, Moriyama Y, Kikkawa F. Relationship between cytokine profiles of cord blood and cord S100B levels in preterm infants. Early Hum Dev. 2019 Feb;129:65-70. doi: 10.1016/j.earlhumdev.2019.01.013. Epub 2019 Jan 23. No abstract available.
PubMed 30684905
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06984445
- Acronym / sponsor ID
- S100BIUT
- Keywords
- S100B protein, hemolytic disease of fetus and newborn (HDFN), intrauterine transfusion (IUT), fetal anemia, newborn, central nervous system (CNS) damage, CNS hypoxia-ischemia (HI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Institute of Mother and Child, Warsaw, PolandUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | 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 birthPregnant 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. |
| Control group | – | 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 birthWomen with pregnancies complicated by HDFN who do not meet the criteria for intrauterine transfusion (IUT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women diagnosed with hemolytic disease of the fetus and newborn (HDFN).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cord blood S100B protein level prior to IUTOne 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 | Study group |
| Umbilical cord blood gas analysis prior to IUTHalf 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 | Study group |
| Fetal blood count evaluation prior to IUTFetal blood count data, including hemoglobin and hematocrit levels, will be collected before each IUT procedure. | Diagnostic test | Study group |
| Cord blood S100B protein concentration at birthAfter 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 | Control group, Study group |
| Umbilical cord blood gas analysis at birthAfter 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 | Control group, Study group |
| Complete blood count after birthComplete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured within six hours after birth. | Diagnostic test | Control group, Study group |
| Ultrasound evaluation of fetal blood flowFetal cerebral blood flow will be routinely assessed via ultrasound, including measurements of MCA-PSV values. | Diagnostic test | Control group, Study group |
| Neonatal transfontanelle ultrasound assessmentA transfontanelle ultrasound examination will. be performed to assess for any abnormalities in the newborn. | Diagnostic test | Control group, Study group |
| Complete blood count analysis in cord blood at birthComplete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured in cord blood samples collected at birth. | Diagnostic test | Control group, Study group |
Primary outcome
Cord blood S100B protein concentration
Time frame: Within 3 months of enrollment
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Background: PubMed 28503958Ree 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.
- Background: PubMed 22030316Lindenburg 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.2011.09.024. Epub 2011 Sep 24.
- Background: PubMed 28426650Mazarico 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.
- Background: PubMed 28234891Malhotra 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.
- Background: PubMed 34105746Strzalko 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.
- Background: PubMed 28756088Zaigham 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.
- Background: PubMed 31622243Bouvier 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.
- Background: PubMed 36829868Perrone 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.
- Background: PubMed 17624933Friel LA, Romero R, Edwin S, Nien JK, Gomez R, Chaiworapongsa T, Kusanovic JP, Tolosa JE, Hassan SS, Espinoza J. The calcium binding protein, S100B, is increased in the amniotic fluid of women with intra-amniotic infection/inflammation and preterm labor with intact or ruptured membranes. J Perinat Med. 2007;35(5):385-93. doi: 10.1515/JPM.2007.101.
- Background: PubMed 19786426Pawluski JL, Galea LA, Brain U, Papsdorf M, Oberlander TF. Neonatal S100B protein levels after prenatal exposure to selective serotonin reuptake inhibitors. Pediatrics. 2009 Oct;124(4):e662-70. doi: 10.1542/peds.2009-0442. Epub 2009 Sep 28.
- Background: PubMed 28738706Lu H, Huang W, Chen X, Wang Q, Zhang Q, Chang M. Relationship between premature brain injury and multiple biomarkers in cord blood and amniotic fluid. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2898-2904. doi: 10.1080/14767058.2017.1359532. Epub 2017 Aug 3.
- Background: PubMed 26285828Chiang LM, Chen WY, Yang YC, Jeng MJ. Elevation of serum S100 protein concentration as a marker of ischemic brain damage in extremely preterm infants. J Chin Med Assoc. 2015 Oct;78(10):610-6. doi: 10.1016/j.jcma.2015.06.009. Epub 2015 Aug 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnieszka A. Drozdowska-Szymczak, MD, PhD principal investigator
Institute of Mother and Child in Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of s100b and Hypoxia-Ischemia, Brain, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka A. Drozdowska-Szymczak, MD, PhD (+48 22 32 77 411, agnieszka.drozdowska@imid.med.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cord blood S100B protein concentration (time frame: Within 3 months of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06984445, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.