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

NCT05530330 | Completed

• 1 other identifier: REC-2022-008
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 2

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

Conditions

Late-Onset Neonatal Sepsis; Necrotising Enterocolitis; Culture Negative Neonatal Sepsis

Keywords

Sepsis; Neonatal; Preterm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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)

  3 years

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

  3 years

Study Arms (1)

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

Interventions

Platelet/Endothelial proteomics DIAGNOSTIC_TEST

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

Infants with concern regarding late onset sepsis

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• \<34 weeks corrected gestational age at birth
• Under investigation for Late Onset Neonatal Sepsis (Sepsis of onset \>72 hours of age)

You may not qualify if:

• Major congenital anomaly
• Suspicion of an underlying haematological disorder affecting platelets
• Have received a platelet transfusion prior to sampling

Sponsors & Collaborators

• University College Dublin: lead
• The Rotunda Hospital: collaborator
• National Maternity Hospital, Ireland: collaborator
• Wellcome Trust: collaborator
• Health Research Board, Ireland: collaborator

Study Sites (2)

The National Maternity Hospital

Dublin, Dublin, D2, Ireland

Location

The Rotunda Hospital

Dublin, Ireland

Location

Related Publications (1)

• 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. 2024 Feb;95(3):852-856. doi: 10.1038/s41390-023-02812-x. Epub 2023 Sep 27.

  PMID: 37758864 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

0.5-1.3ml sodium citrate sample taken depending on infant weight

MeSH Terms

Conditions

Neonatal Sepsis; Enterocolitis, Necrotizing; Sepsis; Premature Birth

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Patricia Maguire

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: September 2, 2022
• Primary Completion: February 28, 2025
• Study Completion: June 27, 2025
• Last Updated: July 3, 2025

Record last verified: 2024-12

Locations

IE (2)