drugset / Trial / NCT03549507

CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis

NCT03549507

NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2020-11-04
Primary completion
2024-05-07
Completion
2024-05-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumason Diagnostic / imaging agent 0.03 mg/kg Intravenous
Subject Lumason Diagnostic / imaging agent 0.03 ml Intravenous