CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
There is no bedside imaging technique that can quantify dynamic bowel perfusion with high
soft tissue contrast and sensitivity in necrotizing enterocolitis (NEC). Our goal is to
assess the feasibility of utilizing contrast-enhanced ultrasound (CEUS) in bedside monitoring
of bowel perfusion in NEC. Patients with suspected or diagnosed NEC will be recruited for the
study. Following parental consent, the subject will undergo CEUS, performed separately from
any clinically indicated conventional US, in the ICU. Subjects will be scanned with CEUS at
two different time-points (at the time NEC is first suspected or diagnosed and at time of MRI
scan). The CEUS scans will be interpreted by the sponsor-investigator.
The study will be conducted at one site, The Children's Hospital of Philadelphia. It is
expected that up to 100 subjects will be enrolled per year, for up to two years, for a total
enrollment of up to 200 subjects.