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NCT01790750 · ClinicalTrials.gov registry record · NA
Pocket Echocardiography System (PES) for Detection of PDA in Neonates
A NA study of Patent Ductus Arteriosus, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01790750: Completed NA study of Patent Ductus Arteriosus, sponsored by University of Florida.
NCT01790750 is a NA study of Patent Ductus Arteriosus that has completed, run by University of Florida. The registered enrollment target is 50 participants, below the 275-participant average among 7 other Patent Ductus Arteriosus trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01790750, a NA study of Patent Ductus Arteriosus, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, feasibility study involving all neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation. Parents will be approached and provided a description of the study. No written consent will be requested, but parents have the option of opting out. Each patient will have a 5 minute Pocket echocardiography system scan followed by a full echo performed on a traditional full featured echo system. The objective is to assess if the current Food and Drug administration (FDA) approved Pocket echocardiography system (PES) can detect patent ductus arteriosus (PDA) in neonates as comparable to traditional full featured echo systems (FFES) and/or physical exam alone.
Primary Outcome
Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false positives between the two systems.
Conditions Studied
Interventions
- DEVICE PES first, then FFES
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-05 |
| Phase | NA |
What the finished NCT01790750 record still lists
NCT01790750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 275-participant average among 7 other Patent Ductus Arteriosus trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Patent Ductus Arteriosus appearing as the primary indexed condition, and to 1 intervention - of which PES first, then FFES is the first listed.
NCT01790750 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01790750 about?
NCT01790750 is a clinical study titled "Pocket Echocardiography System (PES) for Detection of PDA in Neonates". This is a single-center, feasibility study involving all neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation. Parents will be approached and provided a description of the study. No written consent will be requested, but parents have the option of opting ou...
What is the current status of trial NCT01790750?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2013-02. Estimated completion is 2013-05.
What conditions does trial NCT01790750 study?
This clinical trial studies the following conditions: Patent Ductus Arteriosus.
What interventions are being tested in trial NCT01790750?
The interventions under investigation include: PES first, then FFES (DEVICE).
Who is sponsoring clinical trial NCT01790750?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01790750 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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