Evaluation of Bowel Perfusion With Contrast-Enhanced Ultrasound in Necrotizing Enterocolitis

18-014910

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.

2020-11-04

2024-06-12

2024-06-12

Recruiting

Early phase I

200

Inclusion Criteria: 1. Males and females aged 1.5 years or younger 2. Post menstrual age of 29 weeks or older 3. Patients with suspected or diagnosed necrotizing enterocolitis 4. Patient in the Children's Hospital of Philadelphia (CHOP) neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU) 5. Parental permission Exclusion Criteria: 1. Medical history of Lumason hypersensitivity 2. Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team including ≥ 1 intensive care physician not part of the study team 3. Pulmonary insufficiency as defined by FiO2 requirements of \>40% and/or subjects with pulmonary hypertension requiring nitric oxide

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-01-19