Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis

University of Virginia144 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

144

Conditions

Sepsis Necrotising Enterocolitis Neonatal

Interventions

No Intervention: Observational CohortOTHER

No Intervention: Observational Cohort

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Less than 1500 grams at birth Exclusion Criteria: * none

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

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