Late-Onset Neonatal SepsisPARENTNCT05530330
Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
An observational study of Late-Onset Neonatal Sepsis and Necrotising Enterocolitis, run by University College Dublin at 2 sites in Ireland.
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 Read more about this study
- Who is it for?
- Ages Up to 34 weeks
- Conditions the study is for
- Late-Onset Neonatal Sepsis, Necrotising Enterocolitis, Culture Negative Neonatal Sepsis
- What is being tested?
- Platelet/Endothelial proteomics
- How many people
- 268 participants
- Where
- 2 sitesIreland
- Study dates
- 2 Sep 2022to 27 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants less than 34 weeks corrected gestational age at birth who are undergoing investigations for late onset sepsis
Who may be able to join
- <34 weeks corrected gestational age at birth
- Under investigation for Late Onset Neonatal Sepsis (Sepsis of onset >72 hours of age)
Who cannot join
- Major congenital anomaly
- Suspicion of an underlying haematological disorder affecting platelets
- Have received a platelet transfusion prior to sampling
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
The National Maternity Hospital
Dublin, Dublin, D2
The Rotunda Hospital
Dublin
About this study
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
Read the 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
- Being tested
- Platelet/Endothelial proteomics
- Keywords
- Sepsis, Neonatal, Preterm
- Medical subject headings
- Neonatal Sepsis, Enterocolitis, Necrotizing, Sepsis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet/Endothelial proteomicsDiagnostic test
Samples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Platelet/Endothelial proteomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (3)
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
Measured: 3 years
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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start2 Sep 2022
- Primary completion28 Feb 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Late-Onset Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- The Rotunda Hospital, National Maternity Hospital, Ireland, Wellcome Trust, Health Research Board, Ireland
- Responsible party
- Sponsor
- Investigators
- Patricia Maguire, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530330
- Sponsor's protocol ID
- REC-2022-008
- Acronym
- PARENT
- Status last verified
- Dec 2024
- First submitted
- 2 Sep 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Summary data will be available to other researchers, individual data will be withheld as much as required by GDPR requirements
Publications
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.
PubMed 37758864
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
- ClinicalTrials.gov ID
- NCT05530330
- Acronym / sponsor ID
- PARENT / REC-2022-008
- Keywords
- Sepsis, Neonatal, Preterm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- The Rotunda Hospital, National Maternity Hospital, Ireland, Wellcome Trust, Health Research Board, Ireland
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with concern regarding late onset sepsis | – | Diagnostic Test: Platelet/Endothelial proteomicsInfants 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) |
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants less than 34 weeks corrected gestational age at birth who are undergoing investigations for late onset sepsis
Key inclusion criteria (2 listed)
- <34 weeks corrected gestational age at birth
- Under investigation for Late Onset Neonatal Sepsis (Sepsis of onset >72 hours of age)
Key exclusion criteria (3 listed)
- Major congenital anomaly
- Suspicion of an underlying haematological disorder affecting platelets
- Have received a platelet transfusion prior to sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet/Endothelial proteomicsSamples taken will undergo a targeted proteomic investigation examining platelet/endothelial markers and associated extracellular vesicles | Diagnostic test | Infants with concern regarding late onset sepsis |
Primary outcome
A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles
Time frame: 3 years
Proteomic profiles including extracellular vesicles will be compared between those with and without culture proven sepsis
3 secondary outcomes
To examine platelet markers in this same cohort and determine if they can distinguish between culture negative sepsis and non-sepsis
Time frame: 3 years
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)
Time frame: 3 years
To determine if platelet activation markers predict the development of necrotising enterocolitis (Radiological/Surgical)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 37758864O'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.
- Individual participant dataSharing planned: Undecided. Summary data will be available to other researchers, individual data will be withheld as much as required by GDPR requirements
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CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Maguire principal investigator
University College Dublin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Late-Onset Neonatal Sepsis and Necrotising Enterocolitis, run by University College Dublin at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A difference exists between infants with culture proven late onset sepsis and those without in platelet and endothelial proteomic profiles (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.