S100BNCT07093723
Protein S100B Versus Neutrophils/Lymphocytes Ratio in Early Prediction of Brain Injury
An observational study of S100B and Neutrophils/Lymphocytes Ratio, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- S100B, Neutrophils/Lymphocytes Ratio, Prediction
- What is being tested?
- S100B Protein and Neutrophils to Lymphocytes ratio
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 36 weeks
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- Gestational age between 28 and 36 weeks.
- Prematurity.
Who cannot join
- Intrauterine growth restriction (IUGR).
- Multiple congenital anomalies.
- Chromosomal abnormalities.
- Preterm less than 28 weeks.
- Infant of diabetic mother.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- S100B, Neutrophils/Lymphocytes Ratio, Prediction, Brain Injury
- Being tested
- S100B Protein, Neutrophils to Lymphocytes ratio
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S100B ProteinDiagnostic test
Serum level of S100B Protein was measured on the first and third days of seizure activity by ELISA.
Neutrophils to Lymphocytes ratioDiagnostic test
Neutrophils to Lymphocytes ratio was measured on the first and third day of seizure activity obtained by complete blood count.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Preterm neonates, their gestational age between 28- 36 gestational weeks Receives: Diagnostic Test: S100B Protein; Diagnostic Test: Neutrophils to Lymphocytes ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein S100B
Serum level of S100B Protein was measured on the first and third days of seizure activity by ELISA.
Measured: Third day of seizure activity
Secondary outcomes (1)
Neutrophils/Lymphocytes Ratio
Neutrophils to Lymphocytes ratio was measured on the first and third day of seizure activity obtained by complete blood count.
Measured: Third day of seizure activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Sep 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for S100BStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mahmoud Abdel Hamid Elmesiry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093723
- Sponsor's protocol ID
- 36264PR392/10/23
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein S100B Versus Neutrophils/Lymphocytes Ratio in Early Prediction of Brain Injury
- ClinicalTrials.gov ID
- NCT07093723
- Acronym / sponsor ID
- 36264PR392/10/23
- Conditions
- S100B, Neutrophils/Lymphocytes Ratio, Prediction, Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: S100B Protein, Diagnostic Test: Neutrophils to Lymphocytes ratioPreterm neonates, their gestational age between 28- 36 gestational weeks |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Gestational age between 28 and 36 weeks.
- Prematurity.
Key exclusion criteria (5 listed)
- Intrauterine growth restriction (IUGR).
- Multiple congenital anomalies.
- Chromosomal abnormalities.
- Preterm less than 28 weeks.
- Infant of diabetic mother.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S100B ProteinSerum level of S100B Protein was measured on the first and third days of seizure activity by ELISA. | Diagnostic test | Study group |
| Neutrophils to Lymphocytes ratioNeutrophils to Lymphocytes ratio was measured on the first and third day of seizure activity obtained by complete blood count. | Diagnostic test | Study group |
Primary outcome
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.
1 secondary outcome
Neutrophils/Lymphocytes Ratio
Time frame: Third day of seizure activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of S100B and Neutrophils/Lymphocytes Ratio, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein S100B (time frame: Third day of seizure activity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.