Phase 3
Completed N=1
CEUS Evaluation of Hypoxic Ischemic Injury
hypoxic-ischemic encephalopathy · Brain Ischemia Hypoxia
Source: ClinicalTrials.gov NCT03549520 ↗
Enrolled (actual)
1
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Detection of Brain Perfusion Abnormalities Using Contrast-enhanced Ultrasound — 1; 0 Participants
◆ Published Evidence
Established
50citations · ~7 / year
Advanced Ultrasound Techniques for Pediatric Imaging.
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 (HII). 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.
Linked Publications
-
Advanced Ultrasound Techniques for Pediatric Imaging.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Brain Perfusion Abnormalities Using Contrast-enhanced Ultrasound |
1; 0 | — |
| SECONDARY Number of Participants With Completed Brain CEUS Exams, Categorized by Diagnostic-Quality Scoring System |
0; 0; 0; 1 | — |
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 Children's Hospital of Philadelphia (CHOP) Neonatal Intensive Care Unit (NICU) or Pediatric Intensive Care Unit (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 fraction of inspired oxygen (FiO2) requirements of > 40% and/or subjects with pulmonary hypertension requiring nitric oxide
Data sourced from ClinicalTrials.gov (NCT03549520) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.