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

Late-Onset Neonatal Sepsis Clinical Trial

— PARENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530330
• Other study ID #: REC-2022-008
• Status: Recruiting
• Start date: September 2, 2022
• Est. completion date: July 14, 2025

Study information

• Verified date: November 2023
• Source: University College Dublin
• Contact: Daniel O'Reilly
• Phone: +353876610771
• Email: daniel.oreilly2[@]ucdconnect.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 14, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Late-Onset Neonatal Sepsis
• Necrotising Enterocolitis
• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Platelet/Endothelial proteomics
Samples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles

Locations

Country	Name	City	State
Ireland	The National Maternity Hospital	Dublin
Ireland	The Rotunda Hospital	Dublin

Sponsors (5)

Lead Sponsor	Collaborator
University College Dublin	Health Research Board, Ireland, National Maternity Hospital, Ireland, The Rotunda Hospital, Wellcome Trust

Country where clinical trial is conducted

Ireland, 

References & 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. 2023 Sep 27. doi: 10.1038/s41390-023-02812-x. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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