Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Necrotizing Enterocolitis
- Sponsor
- Children's Mercy Hospital Kansas City
- Enrollment
- 169
- Locations
- 2
- Primary Endpoint
- Days to Full Enteral Feeds: Extended Rule Out Group
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
Sherwin Chan MD PhD
Pediatric Radiologist
Children's Mercy Hospital Kansas City
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Days to Full Enteral Feeds: Extended Rule Out Group
Time Frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Days to Full Enteral Feeds: NEC Ruled In
Time Frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Days to Full Enteral Feeds: Quick Rule Out Group
Time Frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Secondary Outcomes
- Days to End Bowel Rest: Quick Rule Out Group(within 14 days of NEC concern)
- Days to End Antibiotics: Quick Rule Out(within 14 days of NEC concern)
- Days to End Antibiotics: NEC Rule In(within 14 days of NEC concern)
- Days to End Bowel Rest: Extended Rule Out Group(within 14 days of NEC concern)
- Days to End Bowel Rest: NEC Ruled In(within 14 days of NEC concern)
- Days to End Antibiotics: Extended Rule Out(within 14 days of NEC concern)