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

University College Dublin268 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

268

Conditions

Late-Onset Neonatal Sepsis Necrotising Enterocolitis Culture Negative Neonatal Sepsis

Interventions

Platelet/Endothelial proteomicsDIAGNOSTIC_TEST

Samples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles

Eligibility

Sex: ALLMax age: 34 Weeks

Medical Language ↔ Plain English

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

Locations (2)

The National Maternity Hospital

Dublin, Dublin, Ireland

The Rotunda Hospital

Dublin, Ireland

Outcomes

Primary Outcomes

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

Time frame: 3 years

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 3 years

Data from ClinicalTrials.gov

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