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s100bNCT06893926

Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

An observational study of s100b and Hypoxia-Ischemia, Brain, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Prenatal ultrasound examination with blood flow analysis, Umbilical cord blood gas analysis and Umbilical cord blood S100B protein level
How many people
120 participants
Where
1 sitePoland
Study dates
18 Jun 2024to 31 Mar 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: Women with a full-term pregnancy.

Study Group - Inclusion Criteria:

  1. Women with a full-term pregnancy (≥37 weeks of gestation), singleton.
  2. Pregnancy complicated by FGR.

Study Group - Exclusion Criteria:

  1. Antenatal (at recruitment):
  • 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).
  1. 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.

Control Group - Inclusion Criteria:

  1. Women with a full-term pregnancy (≥37 weeks of gestation), singleton.
  2. Pregnancy not complicated by FGR.

Control Group - Exclusion Criteria:

  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.
  1. 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.
  1. Postnatal:
  • Neonatal anemia requiring a top-up transfusion within the first 24 hours of life

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Poland1 site, 1 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

    Recruiting

Other trials in Poland

About this study

Official title: Evaluating the Utility of S100B Protein Concentration for Diagnosing Fetal Central Nervous System Hypoxia-Ischemia in Children With Late Fetal Growth Retardation: A Prospective Cohort Study

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.

Being tested
Prenatal ultrasound examination with blood flow analysis, Umbilical cord blood gas analysis, Umbilical cord blood S100B protein level, Neonatal transfontanelle ultrasound assessment
Keywords
S100B protein, fetal growth restriction (FGR), newborn, central nervous system (CNS) damage, CNS hypoxia-ischemia (HI)
Medical subject headings
Hypoxia-Ischemia, Brain, Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prenatal ultrasound examination with blood flow analysisDiagnostic 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:

    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 analysisDiagnostic 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 levelDiagnostic 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 assessmentDiagnostic test

    A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.

Study groups in NCT06893926
Study groupRoleWhat they receive
Study groupWomen with a full-term pregnancy and a prenatal diagnosis of late-onset FGR.
Receives: Diagnostic Test: Prenatal ultrasound examination with blood flow analysis; Diagnostic Test: Umbilical cord blood gas analysis; Diagnostic Test: Umbilical cord blood S100B protein level; Diagnostic Test: Neonatal transfontanelle ultrasound assessment
Control groupWomen with a full-term pregnancy and normal fetal development.
Receives: Diagnostic Test: Prenatal ultrasound examination with blood flow analysis; Diagnostic Test: Umbilical cord blood gas analysis; Diagnostic Test: Umbilical cord blood S100B protein level; Diagnostic Test: Neonatal transfontanelle ultrasound assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 3 months of enrollment

Secondary outcomes (2)

  1. 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.

    Measured: Within 3 months of enrollment

  2. 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.

    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.

  1. First posted25 Mar 2025
  2. Study start18 Jun 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06893926
Sponsor's protocol ID
S100BFGR
Status last verified
Mar 2025
First submitted
6 Mar 2025
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28426650

  • 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.

    PubMed 34105746

  • 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.

    PubMed 28234891

  • 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.

    PubMed 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.

    PubMed 31622243

  • 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.

    PubMed 25392968

  • 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.

    PubMed 36829868

  • 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.

    PubMed 26285828

  • 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.

    PubMed 20036928

  • 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.

    PubMed 25966206

  • 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.

    PubMed 34573263

  • 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.

    PubMed 28738706

  • 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.

    PubMed 17624933

  • 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.

    PubMed 30684905

  • 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.

    PubMed 12496231

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 25 Mar 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 NCT06893926, which also lists 26 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 25 Mar 2025.

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