Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction
NCT ID: NCT06893926
Last Updated: 2025-03-25
Study Results
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Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-06-18
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study group
Women with a full-term pregnancy and a prenatal diagnosis of late-onset FGR.
Prenatal ultrasound examination with blood flow analysis
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:
1. Measurement of fetal anthropometric parameters and estimation of fetal weight.
2. Evaluation of blood flow using the pulsatility index (PI) in the UA, UtA, DV, and MCA.
Umbilical cord blood gas analysis
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
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
A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.
Control group
Women with a full-term pregnancy and normal fetal development.
Prenatal ultrasound examination with blood flow analysis
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:
1. Measurement of fetal anthropometric parameters and estimation of fetal weight.
2. Evaluation of blood flow using the pulsatility index (PI) in the UA, UtA, DV, and MCA.
Umbilical cord blood gas analysis
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
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
A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.
Interventions
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Prenatal ultrasound examination with blood flow analysis
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:
1. Measurement of fetal anthropometric parameters and estimation of fetal weight.
2. Evaluation of blood flow using the pulsatility index (PI) in the UA, UtA, DV, and MCA.
Umbilical cord blood gas analysis
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
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
A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.
Eligibility Criteria
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Inclusion Criteria
2. Pregnancy complicated by FGR.
1. Women with a full-term pregnancy (≥37 weeks of gestation), singleton.
2. Pregnancy not complicated by FGR.
Exclusion Criteria
* Maternal conditions that may affect the blood flow in placental vessels, including smoking, use of illicit stimulant substances, or pregestational diabetes.
* Maternal depression requiring pharmacological treatment (e.g., SSRIs).
2. Intrapartum:
* Factors indicating a possible intrauterine infection, such as amniotic fluid leakage for more than 15 hours, spontaneous preterm labor, diagnosed intrauterine infection, or symptoms of infection in the mother.
* Prolonged labor lasting more than 15 hours.
1. Antenatal (at recruitment):
* Maternal conditions that may affect placental blood flow, such as smoking, use of illicit stimulant substances, pregestational diabetes, or chronic hypertension.
* Maternal depression requiring pharmacological treatment (e.g., SSRIs).
* Risk factors for intrauterine HI, including abnormal fetal blood flow parameters on ultrasound, abnormal CTG recordings, or the need for intrauterine transfusion.
2. Intrapartum:
* Indicators of possible intrauterine infection, such as amniotic fluid leakage for more than 15 hours, spontaneous preterm delivery, diagnosed intrauterine infection, or maternal symptoms of infection.
* Risk factors for perinatal HI.
* Prolonged labor lasting more than 15 hours (counted from the onset of regular uterine contractions).
* Birth weight below the 10th percentile or above the 90th percentile.
* Apgar score less than 8 at the 1st, 3rd, 5th, or 10th minute of life.
* Abnormal umbilical cord blood gas analysis results, defined as pH \< 7.15 or BE \< -9.3 mmol/l.
3. Postnatal:
* Neonatal anemia requiring a top-up transfusion within the first 24 hours of life
18 Years
FEMALE
No
Sponsors
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Institute of Mother and Child, Warsaw, Poland
OTHER
Responsible Party
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Agnieszka Drozdowska-Szymczak
MD, PhD
Principal Investigators
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Agnieszka A. Drozdowska-Szymczak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Mother and Child in Warsaw, Poland
Locations
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Institute of Mother and Child
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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Other Identifiers
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S100BFGR
Identifier Type: -
Identifier Source: org_study_id
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