Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
Status
Conditions
Treatments
Details and patient eligibility
About
The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
169 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Maura Sien, MS, RT(R); Sarah Foster, RT(R)
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal