Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

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Description

The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.

Targeted Conditions

Study Overview

Start Date
November 1, 2022
Completion Date
December 31, 2025
Enrollment
160
Date Posted
October 10, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
University of Kansas Medical Center
Kansas City, Kansas 66160, United States

Children's Mercy Kansas City
Kansas City, Missouri 64086, United States

Eligibility

Eligibility Criteria
Inclusion Criteria

Admitted to the NICU at CMKC or KUMC
With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist

Exclusion Criteria

• Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed

Study Contact Info

Study Contact Name
Maura Sien, MS, RT(R); Sarah Foster, RT(R)
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
Detailed Description
Bowel ultrasound (BUS) for NEC evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. Advantages of BUS is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. BUS is already being used in centers that have sufficient BUS expertise as an alternative standard of care approach for evaluating NEC, but in a highly variable manner.

Standard ultrasound equipment is all that is needed for BUS. Pre-study training will be conducted for sonographers to acquire the study BUS images using standardized technique. Pre-study training of radiologists will also be conducted to standardize the interpretation of BUS findings for NEC. All BUS for NEC ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. All BUS performed as part of the study will not be charged to patients.
NCTid (if applicable)
NCT05573113