Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Rotunda Hospital | OTHER |
| National Maternity Hospital, Ireland | OTHER |
| Wellcome Trust | OTHER |
| Health Research Board, Ireland |
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet/Endothelial proteomics | Diagnostic Test | Samples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Preterm infants less than 34 weeks corrected gestational age at birth who are undergoing investigations for late onset sepsis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patricia Maguire | University College Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The National Maternity Hospital | Dublin | Dublin | D2 | Ireland | ||
| The Rotunda Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37758864 | Background | 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. |
Not provided
Not provided
Summary data will be available to other researchers, individual data will be withheld as much as required by GDPR requirements
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| D020345 | Enterocolitis, Necrotizing |
| D018805 | Sepsis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018746 | Systemic Inflammatory Response Syndrome |
Not provided
Not provided
| ID | Term |
|---|---|
| D010976 | Platelet Count |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
0.5-1.3ml sodium citrate sample taken depending on infant weight
| 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 |
| 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 |
| Dublin |
| Ireland |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D010979 | Platelet Function Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |