Pocket Echocardiography System (PES) for Detection of PDA in Neonates



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:3/30/2013
Start Date:February 2013
End Date:February 2015
Contact:Curt DeGroff, MD
Email:degroffc@ufl.edu
Phone:352-273-7770

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Pocket Echocardiography System (PES) for Detection of Patent Ductus Arteriosus (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 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.


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.

Inclusion Criteria:

- All newborn infants with orders for cardiac echocardiography evaluation in clinically
stable condition

Exclusion Criteria:

- Known congenital heart disease.

- Clinically unstable (Meaning by unstable patients: Those patients that need
cardiopulmonary resuscitation, or in maximum ventilatory or inotrope support and in
immediate need for Extracorporeal Membrane Oxygenation or major surgery or whenever
the physician attending responsible for the clinical care of the patient considers
that a traditional echo needs to be done urgently)
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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