Overview

CEUS Evaluation of Hypoxic Ischemic Injury

Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
All
Summary
Neonates presenting with neurologic symptoms require rapid, non-invasive imaging with high spatial resolution and tissue contrast. The purpose of this study is to evaluate brain perfusion using contrast-enhanced ultrasound CEUS in bedside monitoring of neonates and infants with hypoxic ischemic injury. Investigational CEUS scan will be performed separately from clinically indicated conventional US, in the ICU. Subjects will be scanned with CEUS at two different time-points (at the time HII is first suspected or diagnosed and at time of MRI scan), separately from clinically indicated ultrasound. The CEUS scan 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborator:
Bracco Diagnostics, Inc
Criteria
Inclusion Criteria:

1. Males and females aged 1.5 years or younger with open fontanelles and known or
suspected hypoxic ischemic injury.

2. Post menstrual age of 34 weeks or older

3. Patient in the CHOP NICU or PICU

4. 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