CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
PES first, then FFESdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01790750
NCT01790750N/ACompleted

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

University of Florida·interventional·Posted Feb 13, 2013·Updated Apr 11, 2014

In Brief

A clinical study evaluating PES first, then FFES for Patent Ductus Arteriosus. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.4 years ago

Interventions

PES first, then FFESdevice

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.