The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
169
Bowel Ultrasound
Abdominal radiograph
University of Kansas Medical Center
Kansas City, Kansas, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
Days to Full Enteral Feeds: Extended Rule Out Group
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Time frame: Within 30 days of NEC concern
Days to Full Enteral Feeds: Quick Rule Out Group
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Time frame: Within 30 days of NEC concern
Days to Full Enteral Feeds: NEC Ruled In
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Time frame: Within 30 days of NEC concern
Days to End Bowel Rest: Extended Rule Out Group
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Time frame: within 14 days of NEC concern
Days to End Bowel Rest: Quick Rule Out Group
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Time frame: within 14 days of NEC concern
Days to End Bowel Rest: NEC Ruled In
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Time frame: within 14 days of NEC concern
Days to End Antibiotics: Extended Rule Out
Number of days infants received antibiotic therapy initiated for NEC concern
Time frame: within 14 days of NEC concern
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Days to End Antibiotics: Quick Rule Out
Number of days infants received antibiotic therapy initiated for NEC concern
Time frame: within 14 days of NEC concern
Days to End Antibiotics: NEC Rule In
Number of days infants received antibiotic therapy initiated for NEC concern
Time frame: within 14 days of NEC concern