Skip to main content
OpenTrials
Completed

NCT Number: NCT05530330

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Late-Onset Neonatal Sepsis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Culture Negative Neonatal Sepsis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Infant, Newborn, Diseases Infections Inflammation Intestinal Diseases Necrotising Enterocolitis Neonatal Sepsis Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

The National Maternity Hospital, Dublin, Ireland

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet/Endothelial proteomics

Diagnostic Test

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

Primary outcomes

  1. A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles

    Time frame: 3 years

    Proteomic profiles including extracellular vesicles will be compared between those with and without culture proven sepsis

Secondary outcomes

  1. To examine platelet markers in this same cohort and determine if they can distinguish between culture negative sepsis and non-sepsis

    Time frame: 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

  2. 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)

    Time frame: 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

  3. To determine if platelet activation markers predict the development of necrotising enterocolitis (Radiological/Surgical)

    Time frame: 3 years

    Proteomic profiles including extracellular vesicles will be compared between those with and without radiological/surgical necrotising enterocolitis as final diagnosis

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • Health Research Board, Ireland
  • National Maternity Hospital, Ireland
  • The Rotunda Hospital
  • Wellcome Trust

Registry information

Acronym: PARENT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 7, 2022
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.