Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Purpose

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

Condition

  • Necrotizing Enterocolitis

Eligibility

Eligible Ages
Under 1 Year
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
AXR Arm 1 		Abdomen Radiograph
  • Diagnostic Test: Abdominal radiograph
    Abdominal radiograph
Active Comparator
AXR + BUS Arm 2 		Abdomen Radiograph + Bowel Ultrasound
  • Diagnostic Test: Bowel Ultrasound
    Bowel Ultrasound
  • Diagnostic Test: Abdominal radiograph
    Abdominal radiograph

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Alain Cuna, MD

More Details

Status
Recruiting
Sponsor
Children's Mercy Hospital Kansas City

Study Contact

Maura Sien, MS, RT(R)
18163026065
mesien@cmh.edu

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.