Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Not Applicable

Recruiting

• Conditions: Necrotizing Enterocolitis
• Interventions: Diagnostic Test: Abdominal radiograph; Diagnostic Test: Bowel Ultrasound

• Registration Number: NCT05573113
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-10
• Study Start: 2022-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXR Arm 1	Abdominal radiograph	Abdomen Radiograph
AXR + BUS Arm 2	Bowel Ultrasound	Abdomen Radiograph + Bowel Ultrasound
AXR + BUS Arm 2	Abdominal radiograph	Abdomen Radiograph + Bowel Ultrasound

Primary Outcome Measures

Name	Time	Method
Impact of imaging algorithm on diagnostic thinking	Through study completion, an average of 2 years	Determine the impact of AXR vs AXR + BUS for NEC evaluation on diagnostic thinking of neonatologists as measured by pre and post imaging surveys asking about diagnostic thinking and confidence using a Likert scale.

Trial Locations

Locations (2)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Children's Mercy Kansas City; 🇺🇸 Kansas City, Missouri, United States