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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 is a Phase 3 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 1 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03549520
The ClinicalTrials.gov registry entry for NCT03549520 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sulfur hexafluoride lipid-type A microspheres is the first listed.
NCT03549520 reports 0 study locations.
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.
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