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

Recruiting

• Conditions: Culture Negative Neonatal Sepsis; Late-Onset Neonatal Sepsis; Necrotising Enterocolitis
• Interventions: Diagnostic Test: Platelet/Endothelial proteomics

• Registration Number: NCT05530330
• Lead Sponsor: University College Dublin

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

Study Timeline

• Study Start: 2022-09-02
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants with concern regarding late onset sepsis	Platelet/Endothelial proteomics	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

The National Maternity Hospital; 🇮🇪 Dublin, Ireland

The Rotunda Hospital; 🇮🇪 Dublin, Ireland