Faculty of Medicine, Tanta University
Tanta, Egypt
Location status: Recruiting
NCT Number: NCT07821190
This study aims to evaluate the diagnostic accuracy of monocyte distribution width (MDW) as a novel biomarker for late-onset neonatal sepsis in preterm neonates and to assess its association with disease severity and short-term clinical outcomes
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Request Info73 hour–28 day
All sexes
Observational
Tanta, Egypt
Location status: Recruiting
Neonatal sepsis is a major cause of morbidity and mortality among newborns worldwide. It represents a systemic inflammatory response to infection that can rapidly progress to severe complications, including multi-organ dysfunction and death. The clinical presentation is often nonspecific, making early diagnosis challenging and frequently delayed. The diagnosis of LOS relies on a combination of clinical suspicion, microbiological confirmation, and supportive laboratory findings. Blood culture remains the gold standard for diagnosis, as it confirms the infection and identifies the causative organism, allowing for targeted antibiotic therapy. Biomarkers play an essential role in the early detection and management of sepsis. Commonly used biomarkers include C-reactive protein (CRP), an indicator of systemic inflammation and infection. However, these markers have limitations, including delayed elevation, lack of specificity, and variability in sensitivity, especially in neonatal populations. Additional diagnostic tools such as molecular assays (e.g., polymerase chain reaction techniques) have improved the speed of pathogen identification but are not yet universally available. Monocyte distribution width (MDW) is a novel hematological parameter that reflects changes in monocyte size and morphology during inflammatory processes. Monocytes are among the first immune cells to respond to infection, undergoing functional and structural alterations that can be quantitatively assessed through MDW.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The study will include:
Exclusion criteria
Monocyte Distribution Width (MDW), which represents the standard deviation of monocyte cell volume, will be measured at the time of first clinical suspicion of LONS, preferably before the initiation of antibiotic therapy when possible, using 2 mL peripheral venous blood collected in EDTA tubes. Blood samples will be analyzed as soon as possible after collection using an automated hematology analyzer that reports MDW. The result will be recorded as part of the CBC without requiring an additional blood sample.
Time frame: At enrollment, with reference classification based on blood culture results available within approximately 5 days
Monocyte distribution width (MDW) will be measured as part of the complete blood count at the time of first clinical suspicion of late-onset neonatal sepsis. Its diagnostic performance for culture-proven late-onset neonatal sepsis will be evaluated using receiver operating characteristic (ROC) curve analysis, including area under the curve (AUC), optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value.
Contact information is provided by the study sponsor or research team.
Tanta University
Other
Monocyte Distribution Width as a Novel Diagnostic Biomarker in Late-Onset Sepsis Among Preterm Neonates
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