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

July 23, 2025 updated by: Asmaa Mahmoud Abdel Hamid Elmesiry, Tanta University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This prospective cross-sectional study will be conducted at the Neonatal Intensive Care Unit (NICU) of the Pediatric Department at Tanta University Hospitals over 3 months, from September 2023 to March 2024.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Preterm neonates, their gestational age between 28- 36 gestational weeks
Diagnostic test: S100B Protein
Serum level of S100B Protein was measured on the first and third days of seizure activity by ELISA.
Diagnostic test: Neutrophils to Lymphocytes ratio
Neutrophils to Lymphocytes ratio was measured on the first and third day of seizure activity obtained by complete blood count.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Third day of seizure activity

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Third day of seizure activity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

July 23, 2025

First Submitted That Met QC Criteria

July 23, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 23, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR392/10/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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