Clinical trial NCT05530330: Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
Official title: Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Late-Onset Neonatal Sepsis
Necrotising Enterocolitis
Culture Negative Neonatal Sepsis
Keywords: Sepsis
Neonatal
Preterm
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: The Rotunda Hospital
name: National Maternity Hospital, Ireland
name: Wellcome Trust
name: Health Research Board, Ireland
First posted: 2022-09-07
Enrollment: 200
Sex: ALL
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Detailed 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

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

Primary outcomes:
measure: A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles
timeFrame: 3 years
Secondary outcomes:
measure: To examine platelet markers in this same cohort and determine if they can distinguish between culture negative sepsis and non-sepsis
timeFrame: 3 years
measure: 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)
timeFrame: 3 years
measure: To determine if platelet activation markers predict the development of necrotising enterocolitis (Radiological/Surgical)
timeFrame: 3 years
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: The National Maternity Hospital
city: Dublin
country: Ireland
facility: The Rotunda Hospital
Study officials:
affiliation: University College Dublin
name: Patricia Maguire
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.