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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

268 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-02

Study Completion Date

2025-06-27

Brief Summary

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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

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Detailed Description

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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

Conditions

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Late-Onset Neonatal Sepsis Necrotising Enterocolitis Culture Negative Neonatal Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants with concern regarding late onset sepsis

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)

Platelet/Endothelial proteomics

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Platelet/Endothelial proteomics

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No