Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis

August 7, 2023 updated by: Aya Gamal Mostafa, Sohag University

Neonatal septicemia remains one of the main causes of neonatal morbidity and mortality . Sepsis which is caused by a dysregulated host response to an infectious trigger leading to a life threatening organ dysfunction was declared by the World Health Organization (WHO) on May 2017 as a global health priority that requires resolution for its prevention , dignosis , and management (Monneret et al., 2019). Despite the advances in perinatal and neonatal sepsis remains high and the outcome is still sever (Chirio et al.,2011) .

HLA-DR is on the surface of monocyte \ macrophages , dendritic cells, and B cells and plays a crucial role in adaptive immune response , More than 30 years ago , researches proved an association between the low level of HLA-DR and the development of sepsis (Cheadle at al .,1991) . A decreased expression of mHLA-DR molecules has been associated with immunoparalysis , which is an inflammatory immune responce that occurs in sepsis .(Pradhan et al.,2016).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Laila M Yousef, Professor
  • Phone Number: 01002976973

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonates of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors for sepsis , e.g., prolonged labor , premature rupture of membrane (PROM) , maternal intrapartum fever and chorioamnionitis , and neonates with sepsis-related clinical signs: temperature instability, apnea , need for supplemental oxygen ,bradycardia , tachycardia , hypotension , hypoperfusion , feeding intolerance and abdominal distension ,

Exclusion Criteria:

  • are the adminstration of antibiotic therapy prior to admission , birth asphyxia , laboratory finding suggestive of inborn error of metabolism , and congenital anomalies including congenital heart diseases .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cases

Neonates of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors , e.g., prolonged labor , premature rupture of membrane (PROM) , maternal intrapartum fever and chorioamnionitis , and neonates with sepsis-related clinical signs :temparature instability , apnea , need for supplemental oxygen , bradycardia , tachycardia , hypotension , hypo

perfusion , feeding intolerance , and abdominal distension .
Diagnostic test: CD64 , HLA-DR

CD64 is atype of integral membrane glycoprotein , when activated , it increases the neutrophils' potential for phagocytosis and bacterial killing .

HLA-DR is on the surface of monocyte\macrophages , dendritic cells and plays a crucial role in adaptive immune response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD64 from a peripheral blood sample measued by FlowCytometry device .
Time Frame: 12 months
A cluster of differentiation 64 is a type of intergral membrane glycoprotein , when activated , it increases the neutrophil, potential for phagocytosis and bacterial killing .
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

July 16, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-07-13MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neonatal Sepsis

Clinical Trials on CD64 , HLA-DR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe