Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07254559

Acronym

PREMO (K)

Enrollment

144

Registered

2025-11-28

Start date

2024-01-01

Completion date

2024-10-31

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotising Enterocolitis Neonatal, Sepsis

Brief 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

Interventions

OTHERNo Intervention: Observational Cohort

No Intervention: Observational Cohort

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Less than 1500 grams at birth

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Sepsis or Necrotizing Enterocolitis	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBrynne Sullivan

University of Virginia

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	144 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Age, Continuous	0 years STANDARD_DEVIATION 0
Birthweight	947 grams STANDARD_DEVIATION 307.468
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants
Gestational age	145 days STANDARD_DEVIATION 22.504
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	5 Participants
Race (NIH/OMB) Black or African American	20 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	34 Participants
Race (NIH/OMB) White	84 Participants
Region of Enrollment United States	144 participants
Sex: Female, Male Female	72 Participants
Sex: Female, Male Male	72 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 144
serious Total, serious adverse events	0 / 144

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026