Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05573113
Study type	Interventional
Source	Children's Mercy Hospital Kansas City
Contact	Maura Sien, MS, RT(R)
Phone	18163026065
Email	mesien@cmh.edu
Status	Recruiting
Phase	N/A
Start date	November 1, 2022
Completion date	December 31, 2025

View Details

See also
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