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

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

Study Overview

• Status: Recruiting
• Conditions: Late-Onset Neonatal Sepsis; Necrotising Enterocolitis; Culture Negative Neonatal Sepsis
• Intervention / Treatment: Diagnostic test: Platelet/Endothelial proteomics

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Daniel O'Reilly; Phone Number: +353876610771; Email: daniel.oreilly2@ucdconnect.ie

Study Locations

• Ireland
  • Dublin, Ireland, D2
    • Recruiting
    • The National Maternity Hospital
    • Contact: Daniel O'Reilly; Phone Number: +353876610771; Email: daniel.oreilly@ucdconnect.ie
    • Contact: Anna Curley; Email: anna.curley@nmh.ie
  • Dublin, Ireland
    • Recruiting
    • The Rotunda Hospital
    • Contact: Daniel O'Reilly; Phone Number: +353876610771; Email: daniel.oreilly@ucdconnect.ie
    • Contact: Naomi McCallion; Email: naomimccallion@rcsi.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants less than 34 weeks corrected gestational age at birth who are undergoing investigations for late onset sepsis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Diagnostic test: Platelet/Endothelial proteomics; Samples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	3 years

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: Wellcome Trust; Health Research Board, Ireland; National Maternity Hospital, Ireland; The Rotunda Hospital
• Investigators: Principal Investigator: Patricia Maguire, University College Dublin

Publications and helpful links

General Publications

• O'Reilly D, Murphy CA, Moore CM, Ni Ainle F, Gormley IC, Morrell CN, Curley A, Mc Callion N, Maguire P. Markers of platelet activation foR identification of late onset sEpsis in infaNTs: PARENT study protocol. Pediatr Res. 2023 Sep 27. doi: 10.1038/s41390-023-02812-x. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 14, 2025

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Sepsis; Neonatal; Preterm
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Gastrointestinal Diseases; Infant, Newborn, Diseases; Gastroenteritis; Intestinal Diseases; Sepsis; Toxemia; Enterocolitis; Enterocolitis, Necrotizing; Neonatal Sepsis
• Other Study ID Numbers: REC-2022-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Summary data will be available to other researchers, individual data will be withheld as much as required by GDPR requirements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No