Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Last updated: November 7, 2025
Sponsor: Children's Mercy Hospital Kansas City
Overall Status: Completed

Phase

N/A

Condition

Crohn's Disease

Treatment

Abdominal radiograph

Bowel Ultrasound

Clinical Study ID

NCT05573113
STUDY00002293
  • Ages < 1
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 Design

Total Participants: 169
Treatment Group(s): 2
Primary Treatment: Abdominal radiograph
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
September 18, 2025

Study 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.

Connect with a study center

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Children's Mercy Kansas City

    Kansas City, Missouri 64086
    United States

    Site Not Available

  • Children's Mercy Kansas City

    Kansas City 4393217, Missouri 4398678 64086
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.