An observational study in Late Onset Neonatal Sepsis, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 73 Hours to 28 Days. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Tanta University · Observational
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
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.
192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 85 observational studies indexed under Neonatal Sepsis.
Browse Neonatal Sepsis studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
A total of 60 preterm neonates with clinical suspicion of late-onset neonatal sepsis (LONS) will be included. All eligible neonates admitted to the Neonatal Intensive Care Unit (NICU) of the Pediatrics Department, Tanta University Hospitals, will be screened, and those meeting the inclusion criteria will be enrolled consecutively at the time of first clinical suspicion of sepsis
Inclusion Criteria:The study will include:
Neonates with clinical suspicion of late-onset neonatal sepsis, defined by the presence of one or more of the following:
Exclusion Criteria:
Neonates with any of the following will be excluded from the study:
This group will include 30 preterm neonates with suspected LONS who fulfill the predefined clinical and laboratory criteria of clinical sepsis and/or have positive blood culture
Diagnostic Test: MDW measurement
It will include 30 neonates evaluated for suspected sepsis who will have negative blood cultures, will not fulfill the predefined clinical sepsis criteria, and will have an alternative non-infectious diagnosis.
Diagnostic Test: MDW 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.
Diagnostic Performance of Monocyte Distribution Width for Late-Onset Neonatal Sepsis
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.
Time frame: At enrollment, with reference classification based on blood culture results available within approximately 5 days
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 37 non-industry observational studies under Neonatal Sepsis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 12 months is below that.
Counting every sponsor, half of 38 studies reached it within 25 months; a quarter within 16 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.