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.

Study Overview

• Status: Completed
• Conditions: Brain Injury; Prediction; S100B; Neutrophils/Lymphocytes Ratio
• Intervention / Treatment: Diagnostic test: S100B Protein; Diagnostic test: Neutrophils to Lymphocytes ratio

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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	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

• Sponsor: Tanta University

Study record dates

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: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries
• 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