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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05985174
Collaborator
(none)
50
1
1
12
4.2

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CD64 , HLA-DR
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. CD64 from a peripheral blood sample measued by FlowCytometry device . [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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 28 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University hospitals Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aya Gamal Mostafa, Resident of clinical and chemical pathology department, Sohag university hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05985174
Other Study ID Numbers:
  • Soh-Med-23-07-13MS
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023