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Clinical Trials/NCT07093723
NCT07093723CompletedNot Applicable

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

Tanta University1 site in 1 country60 target enrollmentStarted: September 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Protein S100B

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
28 Weeks to 36 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Neutrophils/Lymphocytes Ratio(Third day of seizure activity)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Asmaa Mahmoud Abdel Hamid Elmesiry

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

Tanta University

Study Sites (1)

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