Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Late-Onset Neonatal Sepsis
- Sponsor
- University College Dublin
- Enrollment
- 268
- Locations
- 2
- Primary Endpoint
- A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles
Time Frame: 3 years
Proteomic profiles including extracellular vesicles will be compared between those with and without culture proven sepsis
Secondary Outcomes
- 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)