Adults 1 Minute to 18 Months, any sex, with Hypoxic-Ischemic Encephalopathy or Brain Ischemia Hypoxia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Detection of Brain Perfusion Abnormalities Using Contrast-enhanced UltrasoundPrimary· During contrast-enhanced ultrasound examination, up to 15 minutes.
Comparison of brain perfusion between normal subjects (those with suspected or at risk of HII but turn out to be normal on imaging and clinical evaluation) versus HII patients
Patients with HII who underwent CEUS examination
Group
Value
95% CI
Brain Contrast-enhanced Ultrasonography
1
Patients without HII who underwent CEUS examination
Group
Value
95% CI
Brain Contrast-enhanced Ultrasonography
0
Number of Participants With Completed Brain CEUS Exams, Categorized by Diagnostic-Quality Scoring SystemSecondary· During contrast-enhanced ultrasound examination, up to 15 minutes.
Scoring system of non-diagnostic (1), moderate artifacts degrading diagnostic quality (2), mild artifacts without degradation of diagnostic quality (3), and diagnostic (4).
Non-diagnostic
Group
Value
95% CI
Brain Contrast-enhanced Ultrasonography
0
Mild artifacts without degradation of diagnostic quality
Group
Value
95% CI
Brain Contrast-enhanced Ultrasonography
0
Moderate artifacts degrading diagnostic quality
Group
Value
95% CI
Brain Contrast-enhanced Ultrasonography
0
Diagnostic
Group
Value
95% CI
Brain Contrast-enhanced Ultrasonography
1
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Philadelphia
Last refreshed: 14 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03549520.