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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: Clinical Trial Phase 3 study, sponsored by Children's Hospital of Philadelphia.
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, 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
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.
Primary Outcome
Comparison of bowel perfusion between normal subjects (those with suspected or at risk of necrotizing enterocolitis but turn out to be normal on imaging and clinical evaluation) versus NEC patients
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 |
Why NCT03549507 stopped before completion
NCT03549507 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.
NCT03549507 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03549507'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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