Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis

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

Completed

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Key information

Conditions

Sepsis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Infections Inflammation Intestinal Diseases Necrotising Enterocolitis Neonatal Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Less than 1500 grams at birth

Exclusion criteria

none

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention: Observational Cohort

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study 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

Acronym: PREMO (K)

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Nov 28, 2025
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed