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

NCT07093723 | Completed

• 1 other identifier: 36264PR392/10/23
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

S100B; Neutrophils/Lymphocytes Ratio; Prediction; Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neutrophils/Lymphocytes Ratio

  Third day of seizure activity

Study Arms (1)

Study group

Preterm neonates, their gestational age between 28- 36 gestational weeks

Diagnostic Test: S100B Protein; Diagnostic Test: Neutrophils to Lymphocytes ratio

Interventions

S100B Protein DIAGNOSTIC_TEST

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

Study group

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.

Study group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)