Identifying late onset sepsis in preterm infants using platelet markers

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

This study is testing if certain blood markers can help doctors find out if preterm infants have a serious infection called late onset sepsis before they show clear signs of it.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: N/A to 34 Weeks
• Sex: All
• Sponsor: University College Dublin (other)
• Locations: 2 sites (Dublin and 1 other locations)
• Trial ID: NCT05530330 on ClinicalTrials.gov

What this trial studies

The PARENT study aims to investigate platelet and endothelial associated proteins in preterm infants suspected of having late onset sepsis (LOS). Infants born before 34 weeks of gestation will be enrolled prior to any investigations for LOS. When there is clinical concern for sepsis, a small blood sample will be collected for targeted proteomic analysis using mass spectroscopy and flow cytometry. The goal is to determine if these markers can help identify infants with fulminant sepsis before a clinical diagnosis is made.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born at less than 34 weeks of gestation who are under investigation for late onset neonatal sepsis.

Not a fit: Patients with major congenital anomalies, suspected hematological disorders affecting platelets, or those who have received a platelet transfusion prior to sampling may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier and more accurate identification of late onset sepsis in preterm infants, potentially improving outcomes.

How similar studies have performed: While this approach is innovative, similar studies exploring biomarkers for sepsis in neonates have shown promise, suggesting potential for success.

Eligibility criteria

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

Where this trial is running

Dublin and 1 other locations

• The National Maternity Hospital — Dublin, Ireland (RECRUITING)
• The Rotunda Hospital — Dublin, Ireland (RECRUITING)

Study contacts

• Principal investigator: Patricia Maguire — University College Dublin
• Study coordinator: Daniel O'Reilly

Conditions: Late-Onset Neonatal Sepsis, Necrotising Enterocolitis, Culture Negative Neonatal Sepsis, Sepsis, Neonatal, Preterm