Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants

Conditions
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Late-Onset Neonatal Sepsis, Necrotising Enterocolitis, Culture Negative Neonatal Sepsis

Intervention / Treatment
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* Diagnostic Test: Platelet/Endothelial proteomics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <34 weeks corrected gestational age at birth Under investigation for Late Onset Neonatal Sepsis (Sepsis of onset >72 hours of age) Exclusion Criteria: Major congenital anomaly Suspicion of an underlying haematological disorder affecting platelets Have received a platelet transfusion prior to sampling

Ages Eligible for Study
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Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with concern regarding late onset sepsis<br>Infants who are being investigated for late onset sepsis will be included. These infants may ultimately be classified in a number of ways, including culture positive late onset sepsis, culture negative late onset sepsis, necrotising enterocolitis or non infectious etiologies suspected (i.e prematurity) | Diagnostic Test: Platelet/Endothelial proteomics<br>* Samples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles | Proteomic profiles including extracellular vesicles will be compared between those with and without culture proven sepsis | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine platelet markers in this same cohort and determine if they can distinguish between culture negative sepsis and non-sepsis | Proteomic profiles including extracellular vesicles will be compared between those with no culture proven sepsis and those without concern for sepsis/ a likely non infectious etiology | 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) | Proteomic profiles including extracellular vesicles will be compared with the nSOFA to examine if fulminant sepsis (Culture proven/Culture negative) can be predicted | 3 years | 
| To determine if platelet activation markers predict the development of necrotising enterocolitis (Radiological/Surgical) | Proteomic profiles including extracellular vesicles will be compared between those with and without radiological/surgical necrotising enterocolitis as final diagnosis | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Neonatal, Preterm