CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis

Patients scheduled for routine abdominal ultrasound for screening or monitoring of
necrotizing enterocolitis will be recruited for the study. The study will be performed at
Children's Hospital of Philadelphia (CHOP) in the Department of Radiology. CHOP will be the
only site of the study with subjects in the neonatal intensive care unit aged 0 to 1 year of
age.

Following consent, the subject will undergo a routine abdominal ultrasound in the main
department. After completion of the routine abdominal ultrasound, the CEUS exam will be
performed for additional 15 minutes in the same setting. Potential subjects will be
identified in two ways: 1) Identification by neonatologists of patients requiring abdominal
ultrasound during the neonatal intensive care unit stay for suspected, at risk of or
diagnosed necrotizing enterocolitis and 2) Review of ultrasound schedule followed by review
of chart.

Before discussing participation in the study, investigators will confirm eligibility by
reviewing the subjects' medical records. Participation will be discussed between the
Principal Investigator (PI) and the referring neonatologist. Participation will be discussed
with the subject and parents/guardian by the neonatologist and/or radiologist after
identification and confirmation of eligibility. Consent and assent (if required) will be
obtained prior to the exam by the neonatologist (co-investigator) or PI in a private room.
Questions will be answered by the PI or referring neonatologist.

After the routine abdominal ultrasound acquisition, the CEUS scan will be performed in the
same setting. Subjects may be scanned with CEUS up to two times, at different time points
(approximately a week a part), always following standard of care US. Injection of Lumason
contrast agent will be performed via the existing peripheral intravenous line using the
FDA-recommended dose of 0.03 mg/kg. Up to two bolus injections will be performed to evaluate
for dynamic bowel perfusion and several 2-minute cine clips as well as static images will be
acquired during the exam. The imaging criteria for the second bolus dose will be: 1)
hyperperistalsis of bowel loops precluding continuous imaging of bowel loops in a given field
of view during 1 min video clip of wash-in of contrast 2) technical failures including
contrast not reaching the circulation due to inadequate flush in the setting of long IV line
or nonfunctioning IV line.

Qualitative analysis with visual assessment and quantitative analysis of the acquired CEUS
scans will be performed and interpreted by the PI and reviewed by the second radiologist who
is blinded to the reports of the PI. The scans will be assessed for diagnostic quality of
images, artifacts encountered, and the presence of additional contributory diagnostic
information.

Inclusion Criteria:

- Males or females age 0-1 year

- Patients scheduled for a clinically indicated abdominal ultrasound for suspected or
diagnosed necrotizing enterocolitis

- Subject consent or parental/guardian permission (informed consent)

- Subjects who are 36 weeks or older post menstrual age (gestational age + chronologic
age)

Exclusion Criteria:

- Prior allergic reaction to Lumason contrast agent

- Hemodynamically unstable patients

- Subjects with cardiac shunts or pulmonary insufficiency

- Subjects who are intubated and on pressors