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

Completed · Not applicable

Conditions studied: Patent Ductus Arteriosus

In brief

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.

Key facts

Study ID

NCT01790750

Run by

University of Florida

People needed

50

Starts

2013-02-01

Expected to finish

2013-05-01

Last updated by the study team

2014-04-11

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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