Brief Title
Pocket Echocardiography System (PES) for Detection of PDA in Neonates
Official Title
Pocket Echocardiography System (PES) for Detection of Patent Ductus Arteriosus (PDA) in Neonates
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.
Study Type
Interventional
Primary Outcome
False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)
Condition
Patent Ductus Arteriosus
Intervention
PES first, then FFES
Study Arms / Comparison Groups
PES first, then FFES
Description: A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
50
Start Date
February 2013
Completion Date
May 2013
Primary Completion Date
May 2013
Eligibility Criteria
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)
Gender
All
Ages
N/A - 90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Curt DeGroff, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01790750
Organization ID
IRB201200340
Responsible Party
Sponsor
Study Sponsor
University of Florida
Study Sponsor
Curt DeGroff, MD, Principal Investigator, University of Florida
Verification Date
March 2014