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Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis

NCT ID: NCT07254559

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Sepsis Necrotising Enterocolitis Neonatal

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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No Intervention: Observational Cohort

No Intervention: Observational Cohort

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Less than 1500 grams at birth

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Brynne Sullivan

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brynne Sullivan

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K23HD097254

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IER 231718

Identifier Type: OTHER

Identifier Source: secondary_id

21237

Identifier Type: -

Identifier Source: org_study_id