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NCT07254559: PREMO (K)

Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis

Completed Results posted Last updated 17 February 2026
What this trial tests

trial testing No Intervention: Observational Cohort in Sepsis in 144 participants. Completed in 31 October 2024.

Timeline
1 January 2024
Primary endpoint
31 October 2024
31 October 2024

Quick facts

Lead sponsorUniversity of Virginia
StatusCompleted
Study typeOBSERVATIONAL
Enrollment144
Start date1 January 2024
Primary completion31 October 2024
Estimated completion31 October 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Virginia

Who can join

Eligibility, any sex, with Sepsis or Necrotising Enterocolitis Neonatal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Sepsis or Necrotizing Enterocolitis Primary · 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.

GroupValue95% CI
Study Cohort20
Study Cohort124

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of No Intervention: Observational Cohort

Trials testing the same drug.

Other recruiting trials for Sepsis

Currently open trials in the same condition.

Other University of Virginia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07254559.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing