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OpenTrials
Completed

NCT Number: NCT07093723

Protein S100B Versus Neutrophils/Lymphocytes Ratio in Early Prediction of Brain Injury

The study aimed to evaluate the role of Protein S100B versus the neutrophil-to-lymphocyte ratio (NLR) as an early predictor biomarker and the value of amplitude-integrated electroencephalography (aEEG) as an early predictor and prognostic method for neonatal brain injury susceptibility and severity.

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Key information

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

The most prevalent types of newborn brain injury (NBI) are intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), and hypoxic-ischemic encephalopathy (HIE), which can affect neonates born at any gestational age (GA).

Amplitude-integrated EEG (aEEG) is another early predictor and prognostic technique for Neonatal Brain Injury. Electrophysiological brain activity, as measured by aEEG, is a well-established method for giving information on the functional and metabolic status of the brain and the incidence of epileptic seizure episodes.

S100B belongs to the S100 family. Because it is soluble in a 100% saturated solution of ammonium sulfate, it was designated "S100." S100 protein is a calcium-binding cytosolic protein with a molecular weight of 21 kDa comprised of 2 monomers, which are found in a variety of cells and are primarily concentrated in the glial cells of the CNS. Due to its molecular weight, peripheral blood will detect only S100B.

The neutrophil-to-lymphocyte ratio (NLR) reflects changes in neutrophil and lymphocyte levels, which is an indication of inflammation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age between 28 and 36 weeks.
  • Prematurity.

Exclusion criteria

  • Intrauterine growth restriction (IUGR).
  • Multiple congenital anomalies.
  • Chromosomal abnormalities.
  • Preterm less than 28 weeks.
  • Infant of diabetic mother.

Treatment and study plan

S100B Protein

Diagnostic Test

Serum level of S100B Protein was measured on the first and third days of seizure activity by ELISA.

Neutrophils to Lymphocytes ratio

Diagnostic Test

Neutrophils to Lymphocytes ratio was measured on the first and third day of seizure activity obtained by complete blood count.

Primary outcomes

  1. Protein S100B

    Time frame: Third day of seizure activity

    Serum level of S100B Protein was measured on the first and third days of seizure activity by ELISA.

Secondary outcomes

  1. Neutrophils/Lymphocytes Ratio

    Time frame: Third day of seizure activity

    Neutrophils to Lymphocytes ratio was measured on the first and third day of seizure activity obtained by complete blood count.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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