NCT07254559

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 3, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

November 3, 2025

Results QC Date

January 8, 2026

Last Update Submit

January 30, 2026

Conditions

SepsisNecrotising Enterocolitis Neonatal

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Interventions

No Intervention: Observational CohortOTHER

No Intervention: Observational Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neonatal intensive care patients of very low birth weight (VLBW) (\<1500g)

You may qualify if:

  • Less than 1500 grams at birth

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

SepsisEnterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Brynne Sullivan
Organization
University of Virginia School of Medicine
bsa4m@virginia.edu
434- 924-5428

Study Officials

  • Brynne Sullivan

    University of Virginia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

November 3, 2025

First Posted

November 28, 2025

Study Start

January 1, 2024

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

February 17, 2026

Results First Posted

February 17, 2026

Record last verified: 2026-01

Locations

US(1)