An observational study in Late-Onset Neonatal Sepsis, Necrotising Enterocolitis and Culture Negative Neonatal Sepsis, sponsored by University College Dublin. Completed at 2 sites in Ireland. Open to participants aged Up to 34 Weeks. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by University College Dublin · Observational
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
183 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.
This study's enrollment of 268 is above the median of 200 across 84 observational studies indexed under Neonatal Sepsis.
Browse Neonatal Sepsis studies →University College Dublin is the lead sponsor of 108 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preterm infants less than 34 weeks corrected gestational age at birth who are undergoing investigations for late onset sepsis
Exclusion Criteria:
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
Samples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles
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
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
Plan to share: Undecided — Summary data will be available to other researchers, individual data will be withheld as much as required by GDPR requirements
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University College Dublin