跳至主要内容
临床试验/NCT07821190
NCT07821190招募中不适用

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

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Diagnostic Performance of Monocyte Distribution Width for Late-Onset Neonatal Sepsis

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
73 Hours 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control group

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.

干预措施: MDW measurement (Diagnostic Test)

Sepsis group

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

干预措施: MDW measurement (Diagnostic Test)

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lamiaa Khaled Zidan

Lecturer of Pediatrics

Tanta University

研究点 (1)

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