Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-29 @ 2:37 PM
Study NCT ID:
NCT01790750
Status:
COMPLETED
Last Update Posted:
2014-04-11
First Post:
2013-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pocket Echocardiography System (PES) for Detection of PDA in Neonates
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Pocket Echocardiography System (PES) for Detection of Patent Ductus Arteriosus (PDA) in Neonates
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
All newborns admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation will be included in this study. 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. If parents agree to be part of this study, a 5-minute PES scan will be performed first so as to not bias the sonographer. Then, a full echocardiogram study will be performed on a traditional FFES. The scans will be performed at the bedside. The images will be reviewed and compared by fellow and/or attending and by experienced sonographer. The scans will include short axis view, ductal view and arch view.
The objective of the study is to assess if the current FDA approved PES can detect PDA in neonates as comparable to traditional full featured echo systems and/or physical exam alone. Using PES for PDA diagnosis will be an accessible, economic and effective way of complementing the findings in our physical exam by increasing diagnostic accuracy, and detecting PDA's at the bedside comparable to a full size traditional echocardiographic system.
The objective of the study is to assess if the current FDA approved PES can detect PDA in neonates as comparable to traditional full featured echo systems and/or physical exam alone. Using PES for PDA diagnosis will be an accessible, economic and effective way of complementing the findings in our physical exam by increasing diagnostic accuracy, and detecting PDA's at the bedside comparable to a full size traditional echocardiographic system.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: