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

Primary Purpose

Neonatal Sepsis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CD64 , HLA-DR
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Sepsis

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • Sohag University hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cases

Arm Description

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 16, 2023
Last Updated
August 7, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05985174
Brief Title
Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis
Official Title
Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cases
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Diagnostic Test
Intervention Name(s)
CD64 , HLA-DR
Intervention Description
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
Primary Outcome Measure Information:
Title
CD64 from a peripheral blood sample measued by FlowCytometry device .
Description
A cluster of differentiation 64 is a type of intergral membrane glycoprotein , when activated , it increases the neutrophil, potential for phagocytosis and bacterial killing .
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya G Mostafa, Resident
Phone
01009389427
Email
ayagamal@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Laila M Yousef, Professor
Phone
01002976973
Facility Information:
Facility Name
Sohag University hospitals
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor
Phone
0934602963
Email
portal@med.sohag.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21647274
Citation
Chirico G, Loda C. Laboratory aid to the diagnosis and therapy of infection in the neonate. Pediatr Rep. 2011 Feb 24;3(1):e1. doi: 10.4081/pr.2011.e1.
Results Reference
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PubMed Identifier
16601490
Citation
Ng PC, Lam HS. Diagnostic markers for neonatal sepsis. Curr Opin Pediatr. 2006 Apr;18(2):125-31. doi: 10.1097/01.mop.0000193293.87022.4c.
Results Reference
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PubMed Identifier
31537145
Citation
Vazquez Rodriguez S, Arriaga Pizano LA, Laresgoiti Servitje E, Mancilla Ramirez J, Peralta Mendez OL, Villalobos Alcazar G, Granados Cepeda ML, Hernandez Pelaez MG, Cordero Gonzalez G, Arizmendi Villanueva R, Cruz Ramirez JL, Isibasi A, Lopez Macias C, Flores Romo L, Jimenez Zamudio LA, Cerbulo-Vazquez A. Multiparameter flow cytometry analysis of leukocyte markers for diagnosis in preterm neonatal sepsis. J Matern Fetal Neonatal Med. 2021 Jul;34(14):2323-2333. doi: 10.1080/14767058.2019.1666100. Epub 2019 Sep 19.
Results Reference
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PubMed Identifier
28442521
Citation
Aydin M, Barut S, Akbulut HH, Ucar S, Orman A. Application of Flow Cytometry in the Early Diagnosis of Neonatal Sepsis. Ann Clin Lab Sci. 2017 Mar;47(2):184-190.
Results Reference
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Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis

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