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

NCT ID: NCT07093723

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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S100B Neutrophils/Lymphocytes Ratio Prediction Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study group

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

S100B Protein

Intervention Type DIAGNOSTIC_TEST

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

Neutrophils to Lymphocytes ratio

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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S100B Protein

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Mahmoud Abdel Hamid Elmesiry

Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR392/10/23

Identifier Type: -

Identifier Source: org_study_id

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