The Role of Neutrophil CD64 and Soluble Triggering Receptor Expressed on Myeloid Cells 1 in Neonatal Sepsis

NCT03795285 | Unknown

• 1 other identifier: Neonatal sepsis
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neonatal sepsis (NS) is a rather serious but relatively common health problem. Despite recent advances in the treatment of neonatal infection, mortality and comorbidities remain high.

Conditions

Neonatal SEPSIS

Keywords

Early onset sepsis; sTREM-1; Neutrophil CD64

Outcome Measures

Primary Outcomes (1)

• The mean difference of neutrophil CD64 expression and sTREM-1 before and after treatment

  better understanding of neutrophil CD64 role as an essential player in pathogenesis of neonatal sepsis and the role of and sTREM-1 in pathogenesis of neonatal sepsis

  72 hours

Study Arms (2)

Septic neonates:

fifty neonates with sepsis.

Diagnostic Test: Expression of neutrophil CD64

Controls:

twenty healthy neonates.

Diagnostic Test: Expression of neutrophil CD64

Interventions

Expression of neutrophil CD64 DIAGNOSTIC_TEST

Expression of neutrophil CD64 will be measured by Flow cytometry. In addition, sTREM-1 will be measured in the serum by ELISA

Controls:; Septic neonates:

Eligibility Criteria

• Age: 1 Day - 50 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonatal sepsis

You may qualify if:

• Sepsis was defined as a positive blood culture in infants with clinical and laboratory findings of infection. Manifestations of sepsis include poor suckling, sleepiness, respiratory distress, apnea, poor perfusion, cyanosis, bradycardia, fever or hypothermia, feeding intolerance, and neurological signs (as seizures). Routine sepsis evaluations included complete blood count, C-reactive protein, and blood culture.

You may not qualify if:

• malformations
• prematurity
• Apgar score less than seven
• on antibiotics treatment before the start of the study

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Halek J, Novak M, Medkova A, Furst T, Juranova J. The role of nCD64 in the diagnosis of neonatal sepsis in preterm newborns. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018 Jun 21. doi: 10.5507/bp.2018.033. Online ahead of print.

  PMID: 29955185 BACKGROUND

• Wright JK, Hayford K, Tran V, Al Kibria GM, Baqui A, Manajjir A, Mahmud A, Begum N, Siddiquee M, Kain KC, Farzin A. Biomarkers of endothelial dysfunction predict sepsis mortality in young infants: a matched case-control study. BMC Pediatr. 2018 Mar 23;18(1):118. doi: 10.1186/s12887-018-1087-x.

  PMID: 29571293 BACKGROUND

• Ford JW, McVicar DW. TREM and TREM-like receptors in inflammation and disease. Curr Opin Immunol. 2009 Feb;21(1):38-46. doi: 10.1016/j.coi.2009.01.009. Epub 2009 Feb 21.

  PMID: 19230638 BACKGROUND

• Groselj-Grenc M, Ihan A, Derganc M. Neutrophil and monocyte CD64 and CD163 expression in critically ill neonates and children with sepsis: comparison of fluorescence intensities and calculated indexes. Mediators Inflamm. 2008;2008:202646. doi: 10.1155/2008/202646.

  PMID: 18604302 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

reham elmahdy

CONTACT

+201002714637; reham.elmahdy@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 7, 2019
• Study Start: February 20, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 30, 2019
• Last Updated: January 8, 2019

Record last verified: 2019-01