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NCT03549507 · ClinicalTrials.gov registry record · Phase 3
CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis
A Phase 3 study, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT03549507 is a Phase 3 study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 1 participants.
The verdict
NCT03549507, a Phase 3 study, was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
There is no bedside imaging technique that can quantify dynamic bowel perfusion with high soft tissue contrast and sensitivity in necrotizing enterocolitis (NEC). Our goal is to assess the feasibility of utilizing contrast-enhanced ultrasound (CEUS) in bedside monitoring of bowel perfusion in NEC. Patients with suspected or diagnosed NEC will be recruited for the study. Following parental consent, the subject will undergo CEUS, performed separately from any clinically indicated conventional US, in the ICU. Subjects will be scanned with CEUS at two different time-points (at the time NEC is first suspected or diagnosed and at time of MRI scan). The CEUS scans 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 | 2020-11-04 |
| Est. Completion | 2024-05-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03549507
The ClinicalTrials.gov registry entry for NCT03549507 describes a study currently listed as terminated, 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.
NCT03549507 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03549507 about?
NCT03549507 is a clinical study titled "CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis". There is no bedside imaging technique that can quantify dynamic bowel perfusion with high soft tissue contrast and sensitivity in necrotizing enterocolitis (NEC). Our goal is to assess the feasibility of utilizing contrast-enhanced ultrasound (CEUS) in bedside monitoring of bowel perfusion in NEC. P...
What is the current status of trial NCT03549507?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2020-11-04. Estimated completion is 2024-05-07.
What interventions are being tested in trial NCT03549507?
The interventions under investigation include: Sulfur hexafluoride lipid-type A microspheres (DRUG).
Who is sponsoring clinical trial NCT03549507?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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