Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles
研究概览
简要总结
The PARENT study will examine platelet and endothelial associated proteins in preterm infants being investigated for late onset sepsis (LOS) to see if infants with fulminant sepsis can be prospectively identified using these markers
详细描述
Infants who are less than 34 weeks corrected gestational age at time of birth will be enrolled prior to any late onset sepsis investigations. At point of clinical concern for the development of late onset sepsis a 0.5-1.3ml sodium citrate sample will be taken. A targeted proteomic analysis using mass spectroscopy and flow cytometry will be performed and compared with the clinical diagnosis of the infant to examine if this can be used prospectively to identify infants with late onset sepsis
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
- — 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<34 weeks corrected gestational age at birth
- •Under investigation for Late Onset Neonatal Sepsis (Sepsis of onset >72 hours of age)
排除标准
- •Major congenital anomaly
- •Suspicion of an underlying haematological disorder affecting platelets
- •Have received a platelet transfusion prior to sampling
结局指标
主要结局
A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles
时间窗: 3 years
Proteomic profiles including extracellular vesicles will be compared between those with and without culture proven sepsis
次要结局
- To examine platelet markers in this same cohort and determine if they can distinguish between culture negative sepsis and non-sepsis(3 years)
- To determine if platelet activation markers correlate with severity of illness as established by prospective use of validated clinical scoring systems ( the novel neonatal Sequential organ failure assessment)(3 years)
- To determine if platelet activation markers predict the development of necrotising enterocolitis (Radiological/Surgical)(3 years)