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S100B protein is a biomarker that increases following central nervous system (CNS) damage. Measuring this protein's levels may allow for the early identification of infants at high risk for developmental abnormalities, such as fetal growth restriction (FGR), even on the first day of life, in a non-invasive manner. Early detection could enable timely interventions and rehabilitation, potentially improving the child's prognosis and long-term outcomes. This study investigates two groups of full-term pregnancies: a study group with prenatally diagnosed late FGR, and a control group with normal fetal growth. Following delivery, cord blood samples from both groups will be analyzed for S100B protein concentrations, pH, base excess (BE), and lactate levels. Additionally, fetal blood flow parameters in the umbilical artery (UA), uterine arteries (UtA), ductus venosus (DV), and middle cerebral artery (MCA) will be monitored via ultrasound within 48 hours before delivery. This study aims to compare S100B protein concentrations in umbilical cord blood between the two groups and to assess correlations with fetal Doppler parameters, pH, BE, and lactate levels in cord blood gas analysis. Ultimately, we seek to determine the effectiveness of S100B protein concentration as a biomarker for diagnosing fetal CNS hypoxia- ischemia in FGR-affected children, compared to those with normal growth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Women with a full-term pregnancy and a prenatal diagnosis of late-onset FGR. |
| |
| Control group | Women with a full-term pregnancy and normal fetal development. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prenatal ultrasound examination with blood flow analysis | Diagnostic Test | For all patients who provide informed consent to participate in the study, an ultrasound examination is performed within 48 hours prior to delivery. This assessment includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Cord blood S100B protein concentration | The study's primary endpoint will be the concentration of S100B protein measured from a cord blood sample taken after birth in both the study and control groups. | Within 3 months of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis | The potential correlation between cord blood S100B concentration and pH, BE, and lactate levels, as determined by cord blood gas analysis, in both the study and control groups. | Within 3 months of enrollment |
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Study Group - Inclusion Criteria:
Study Group - Exclusion Criteria:
Antenatal (at recruitment):
Intrapartum:
Control Group - Inclusion Criteria:
Control Group - Exclusion Criteria:
Antenatal (at recruitment):
Intrapartum:
Postnatal:
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Women with a full-term pregnancy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnieszka A. Drozdowska-Szymczak, MD, PhD | Contact | +48 22 32 77 411 | agnieszka.drozdowska@imid.med.pl | |
| Sabina A. Łukawska, MD | Contact | +48 691 235 077 | sabina.lukawska@imid.med.pl |
| Name | Affiliation | Role |
|---|---|---|
| Agnieszka A. Drozdowska-Szymczak, MD, PhD | Institute of Mother and Child in Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Mother and Child | Recruiting | Warsaw | 01-211 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28426650 | Background | 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. | |
| 34105746 | Background | 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. |
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serum and whole blood samples
|
| Umbilical cord blood gas analysis | Diagnostic Test | A 0.5 mL blood sample is collected from the clamped section of the umbilical cord and immediately sent to the laboratory for cord blood gas analysis, including the determination of pH, base excess (BE), and lactate levels. |
|
| Umbilical cord blood S100B protein level | Diagnostic Test | A 1 mL sample of cord blood is collected in a labeled tube, which includes the mother's name, the child's gender, date of birth, and date of collection. The sample is then sent to the laboratory for centrifugation. The resulting serum samples are frozen, and once approximately 80 samples have been collected, they will be thawed and analyzed for S100B protein concentration. Any remaining material after laboratory processing will be properly disposed of. |
|
| Neonatal transfontanelle ultrasound assessment | Diagnostic Test | A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn. |
|
| Association between cord blood S100B protein concentration and fetal blood flow parameters |
The potential relationship between cord blood S100B protein concentration and blood flow parameters (PI) in the UA, UtA, DV, and MCA, as assessed by fetal ultrasound performed within 48 hours before delivery. |
| Within 3 months of enrollment |
| 28234891 | Background | 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. |
| 28756088 | Background | 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. |
| 31622243 | Background | 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. |
| 25392968 | Background | Velipasaoglu M, Yurdakok M, Ozyuncu O, Portakal O, Deren O. Neural injury markers to predict neonatal complications in intrauterine growth restriction. J Obstet Gynaecol. 2015;35(6):555-60. doi: 10.3109/01443615.2014.978848. Epub 2014 Nov 13. |
| 36829868 | Background | 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. |
| 26285828 | Background | Chiang 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. |
| 20036928 | Background | Florio 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. |
| 25966206 | Background | Huang 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. |
| 34573263 | Background | Metallinou D, Karampas G, Lazarou E, Iacovidou N, Pervanidou P, Lykeridou K, Mastorakos G, Rizos D. Serum Activin A as Brain Injury Biomarker in the First Three Days of Life. A Prospective Case-Control Longitudinal Study in Human Premature Neonates. Brain Sci. 2021 Sep 20;11(9):1243. doi: 10.3390/brainsci11091243. |
| 28738706 | Background | Lu 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. |
| 17624933 | Background | Friel 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. |
| 30684905 | Background | Niwa 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. |
| 12496231 | Background | Wirds JW, Duyn AE, Geraerts SD, Preijer E, Van Diemen-Steenvoorde JA, Van Leeuwen JH, Haas FJ, Gerritsen WB, De Boer A, Leusink JA. S100 protein content of umbilical cord blood in healthy newborns in relation to mode of delivery. Arch Dis Child Fetal Neonatal Ed. 2003 Jan;88(1):F67-9. doi: 10.1136/fn.88.1.f67. |
| 26421445 | Background | Masaoka N, Nakajima Y, Morooka M, Tashiro H, Wada M, Maruta K, Iwane E, Yamashiro M. The impact of intrauterine infection on fetal brain damage assessed by S100B protein concentrations in umbilical cord arteries. J Matern Fetal Neonatal Med. 2016;29(15):2464-9. doi: 10.3109/14767058.2015.1087501. Epub 2015 Sep 30. |
| 17101566 | Background | Schulpis KH, Margeli A, Akalestos A, Vlachos GD, Partsinevelos GA, Papastamataki M, Antsaklis A, Papassotiriou I. Effects of mode of delivery on maternal-neonatal plasma antioxidant status and on protein S100B serum concentrations. Scand J Clin Lab Invest. 2006;66(8):733-42. doi: 10.1080/00365510600977737. |
| 19786426 | Background | Pawluski 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. |
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| 18313558 | Background | von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008. |
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| 33184833 | Background | Kwiatkowski S, Torbe A, Borowski D, Breborowicz G, Czajkowski K, Huras H, Kajdy A, Kalinka J, Kosinska-Kaczynska K, Leszczynska-Gorzelak B, Rokita W, Ropacka-Lesiak M, Sieroszewski P, Wielgos M, Zimmer M. Polish Society of Gynecologists and Obstetricians Recommendations on diagnosis and management of fetal growth restriction. Ginekol Pol. 2020;91(10):634-643. doi: 10.5603/GP.2020.0158. No abstract available. |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
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