NCT05573113

Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bowel Ultrasound	Bowel Ultrasound
DIAGNOSTIC_TEST	Abdominal radiograph	Abdominal radiograph

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-09-23
• Completion: 2025-09-18
• First posted: 2022-10-10
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study