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MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates

Monocyte Distribution Width as a Novel Diagnostic Biomarker in Late-Onset Sepsis Among Preterm Neonates

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07821190
Enrollment
60
Registered
2026-09-15
Start date
2026-07-01
Completion date
2027-07-30
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late Onset Neonatal Sepsis

Keywords

MDW, LONS

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTMDW measurement

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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
73 Years to 28 Days

Inclusion criteria

The study will include: 1. Preterm neonates with gestational age \<37 weeks. 2. Neonates aged \>72 hours of life at the time of enrollment. 3. Neonates with clinical suspicion of late-onset neonatal sepsis, defined by the presence of one or more of the following: * Temperature instability (core temperature \>38°C or \<36°C) * Respiratory distress or new-onset apnea * Feeding intolerance or poor feeding * Lethargy or irritability * Bradycardia or tachycardia * Hypotension * Unexplained clinical deterioration

Exclusion criteria

* Neonates with any of the following will be excluded from the study: 1. Early onset neonatal sepsis. 2. Major congenital anomalies 3. Chromosomal abnormalities 4. Metabolic disorders 5. Severe perinatal asphyxia 6. Neonates with surgical conditions

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Performance of Monocyte Distribution Width for Late-Onset Neonatal SepsisAt enrollment, with reference classification based on blood culture results available within approximately 5 daysMonocyte 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.

Countries

Egypt

Contacts

CONTACTLamiaa Khaled Zidan
lamia.kh.z@gmail.com00201007958439

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026