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NCT03549520 · ClinicalTrials.gov registry record · Phase 3
CEUS Evaluation of Hypoxic Ischemic Injury
A Phase 3 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT03549520: Completed Phase 3 study, sponsored by Children's Hospital of Philadelphia.
NCT03549520 is a Phase 3 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549520, a Phase 3 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Sulfur hexafluoride lipid-type A microspheres
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2024-05-07 |
| Phase | Phase 3 |
What the finished NCT03549520 record still lists
NCT03549520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Sulfur hexafluoride lipid-type A microspheres is the first listed.
NCT03549520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03549520 about?
NCT03549520 is a clinical study titled "CEUS Evaluation of Hypoxic Ischemic Injury". 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 inju...
What is the current status of trial NCT03549520?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2020-12-01. Estimated completion is 2024-05-07.
What interventions are being tested in trial NCT03549520?
The interventions under investigation include: Sulfur hexafluoride lipid-type A microspheres (DRUG).
Who is sponsoring clinical trial NCT03549520?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03549520's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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