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

University College Dublin

Status: Completed

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

Treatments: Diagnostic Test: Platelet/Endothelial proteomics

Study type: Observational

Funder types: Other

Identifiers

NCT05530330

REC-2022-008

Details and patient eligibility

About

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

Full 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

Enrollment: 268 patients

Sex: All

Ages: Under 34 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

268 participants in 1 patient group

Infants with concern regarding late onset sepsis

Description:

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)

Treatment:

Diagnostic Test: Platelet/Endothelial proteomics