Culture Negative Neonatal Sepsis, Late-Onset Neonatal Sepsis, Necrotising Enterocolitis
Conditions
Keywords
Sepsis, Neonatal, Preterm
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
Interventions
DIAGNOSTIC_TESTPlatelet/Endothelial proteomics
Samples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles
Sponsors
The Rotunda Hospital
National Maternity Hospital, Ireland
Wellcome Trust
Health Research Board, Ireland
University College Dublin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 34 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles | 3 years | Proteomic profiles including extracellular vesicles will be compared between those with and without culture proven sepsis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To examine platelet markers in this same cohort and determine if they can distinguish between culture negative sepsis and non-sepsis | 3 years | 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 |
| 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 | Proteomic profiles including extracellular vesicles will be compared with the nSOFA to examine if fulminant sepsis (Culture proven/Culture negative) can be predicted |
| To determine if platelet activation markers predict the development of necrotising enterocolitis (Radiological/Surgical) | 3 years | Proteomic profiles including extracellular vesicles will be compared between those with and without radiological/surgical necrotising enterocolitis as final diagnosis |
Countries
Ireland
Outcome results
None listed