MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates
ConditionLate Onset Neonatal Sepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age73-28
SponsorTanta University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm neonates with gestational age <37 weeks.
Neonates aged >72 hours of life at the time of enrollment.
Temperature instability (core temperature >38°C or <36°C)
Respiratory distress or new-onset apnea
Disqualifiers
Early onset neonatal sepsis.
Major congenital anomalies
Chromosomal abnormalities
Metabolic disorders
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MDW measurement
Diagnostic testMonocyte 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sepsis group1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
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 daysSponsors and contacts
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Source ClinicalTrials.gov