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NCT Number: NCT07821190

MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates

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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Key information

Age range

73 hour–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Tanta University

Tanta, Egypt

Location status: Recruiting

Location contact

Faculty of Medicine, Tanta University

CONTACT

[email protected]

2+ 040 3337544

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The study will include:

  • Preterm neonates with gestational age <37 weeks.
  • Neonates aged >72 hours of life at the time of enrollment.
  • 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:
  • Early onset neonatal sepsis.
  • Major congenital anomalies
  • Chromosomal abnormalities
  • Metabolic disorders
  • Severe perinatal asphyxia
  • Neonates with surgical conditions

Treatment and study plan

MDW measurement

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic Performance of Monocyte Distribution Width for Late-Onset Neonatal Sepsis

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lamiaa Khaled Zidan

CONTACT

[email protected]

00201007958439

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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