CEUS Evaluation of Hypoxic Ischemic Injury

Phase 3

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy; Brain Ischemia Hypoxia

• Registration Number: NCT03549520
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-5-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Males and females aged 1.5 years or younger with open fontanelles and known or<br> suspected hypoxic ischemic injury.<br><br> 2. Post menstrual age of 34 weeks or older<br><br> 3. Patient in the Children's Hospital of Philadelphia (CHOP) Neonatal Intensive Care<br> Unit (NICU) or Pediatric Intensive Care Unit (PICU)<br><br> 4. Parental permission<br><br>Exclusion Criteria:<br><br> 1. Medical history of Lumason hypersensitivity<br><br> 2. Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in<br> the past 12-24 hours, as defined by the clinical care team including = 1 intensive<br> care physician not part of the study team<br><br> 3. Pulmonary insufficiency as defined by fraction of inspired oxygen (FiO2)<br> requirements of > 40% and/or subjects with pulmonary hypertension requiring nitric<br> oxide

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative and quantitative assessment of CEUS evaluation of brain perfusion