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
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator AXR Arm 1 |
Abdomen Radiograph |
|
Active Comparator AXR + BUS Arm 2 |
Abdomen Radiograph + Bowel Ultrasound |
|
Recruiting Locations
Kansas City, Kansas 66160
Alain Cuna, MD
More Details
- Status
- Recruiting
- Sponsor
- Children's Mercy Hospital Kansas City
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.