Protein S100B Versus Neutrophils/Lymphocytes Ratio in Ear... | NCT07093723

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

NCT07093723

Sponsor

Tanta University

Status

Completed

Last Update Posted

Jul 30, 2025Actual

Enrollment

60Actual

Phase

Not provided

Conditions

S100B
Neutrophils/Lymphocytes Ratio
Prediction
Brain Injury

Interventions

S100B Protein
Neutrophils to Lymphocytes ratio

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Mar 1, 2024Actual

Completion Date

Mar 1, 2024Actual

First Submitted Date

Jul 23, 2025

First Submission Date that Met QC Criteria

Jul 23, 2025

First Posted Date

Jul 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2025

Last Update Posted Date

Jul 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Asmaa Mahmoud Abdel Hamid Elmesiry, Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Preterm neonates, their gestational age between 28- 36 gestational weeks	Diagnostic Test: S100B Protein Diagnostic Test: Neutrophils to Lymphocytes ratio

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S100B Protein	Diagnostic Test	Serum level of S100B Protein was measured on the first and third days of seizure activity by ELISA.	Study group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Weeks

Maximum Age

36 Weeks

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University		Tanta	El-Gharbia	31527	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

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Browse Branches

Not provided