Bowel Ultrasound
Diagnostic TestBowel Ultrasound
NCT Number: NCT05573113
The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
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Notify MeUp to 1 year
All sexes
Interventional
Not applicable
University of Kansas Medical Center, Kansas City, Kansas, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bowel Ultrasound
Abdominal radiograph
Time frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Time frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Time frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Time frame: within 14 days of NEC concern
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Time frame: within 14 days of NEC concern
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Time frame: within 14 days of NEC concern
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Time frame: within 14 days of NEC concern
Number of days infants received antibiotic therapy initiated for NEC concern
Time frame: within 14 days of NEC concern
Number of days infants received antibiotic therapy initiated for NEC concern
Time frame: within 14 days of NEC concern
Number of days infants received antibiotic therapy initiated for NEC concern
Children's Mercy Hospital Kansas City
Other
Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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