SepsisPREMO (K)NCT07254559
Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
An observational study of Sepsis and Necrotising Enterocolitis Neonatal, run by University of Virginia at 1 site in United States.
Trial summary
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Necrotising Enterocolitis Neonatal
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonatal intensive care patients of very low birth weight (VLBW) (<1500g)
Who may be able to join
- Less than 1500 grams at birth
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Integrated Physiomarker, Biomarker and Clinical Predictive Analytics for Early Warning of Sepsis and Necrotizing Enterocolitis in Very Low Birth Weight Infants: Pilot Randomized Clinical Trial to Test Feasibility of Integrated Predictive Monitoring for Sepsis and NEC
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
- Conditions
- Sepsis, Necrotising Enterocolitis Neonatal
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Sepsis, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sepsis or Necrotizing Enterocolitis
Late-onset sepsis is defined as a positive blood culture treated with at least 5 days of antibiotics. Necrotizing enterocolitis was defined using Bell's staging criteria to include stage 2 or higher. The outcome was a binary indicator of whether either of these diagnoses was made or neither.
Measured: From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Jan 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Brynne Sullivan, University of Virginia
- Investigators
- Brynne Sullivan, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254559
- Sponsor's protocol ID
- 21237
- Other IDs
- K23HD097254, IER 231718
- Acronym
- PREMO (K)
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Physiomarker, Biomarker and Clinical Predictive Analytics for Early Warning of Sepsis and Necrotizing Enterocolitis in Very Low Birth Weight Infants: Pilot Randomized Clinical Trial to Test Feasibility of Integrated Predictive Monitoring for Sepsis and NEC
- ClinicalTrials.gov ID
- NCT07254559
- Acronym / sponsor ID
- PREMO (K) / 21237
- Conditions
- Sepsis, Necrotising Enterocolitis Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonatal intensive care patients of very low birth weight (VLBW) (<1500g)
Key inclusion criteria (1 listed)
- Less than 1500 grams at birth
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | – |
Primary outcome
Number of Participants With Sepsis or Necrotizing Enterocolitis
Time frame: From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months old
Late-onset sepsis is defined as a positive blood culture treated with at least 5 days of antibiotics. Necrotizing enterocolitis was defined using Bell's staging criteria to include stage 2 or higher. The outcome was a binary indicator of whether either of these diagnoses was made or neither.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
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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.
Brynne Sullivan principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Necrotising Enterocolitis Neonatal, run by University of Virginia at 1 site in United States.
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 1 inclusion and 1 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Sepsis or Necrotizing Enterocolitis (time frame: From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.