CEUS Evaluation of Hypoxic Ischemic Injury
Hypoxic-Ischemic Encephalopathy, Brain Ischemia Hypoxia
About this trial
This is an interventional diagnostic trial for Hypoxic-Ischemic Encephalopathy focused on measuring Ultrasound, Contrast-enhanced ultrasound
Eligibility Criteria
Inclusion Criteria:
- Males and females aged 1.5 years or younger with open fontanelles and known or suspected hypoxic ischemic injury.
- Post menstrual age of 34 weeks or older
- Patient in the CHOP NICU or PICU
- Parental permission
Exclusion Criteria:
- Medical history of Lumason hypersensitivity
- 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
- Pulmonary insufficiency as defined by FiO2 requirements of > 40% and/or subjects with pulmonary hypertension requiring nitric oxide
Sites / Locations
- The Children's Hospital of PhiladelphiaRecruiting
Arms of the Study
Arm 1
Experimental
Contrast-enhanced Ultrasonography
Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing contrast-enhanced ultrasound (CEUS). In pediatric patients, after reconstitution 0.03 mL per kg is administered intravenously. The weight-based dose of 0.03 mL per kg will be repeated one time during a single examination. Following each injection, an intravenous flush of 0.9% Sodium Chloride is injected. The study duration per subject will be approximately 15 minutes including the time to prepare the contrast agent and perform the CEUS, as well as the 60 minute monitoring period after the first and second injection of the contrast agent.