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NCT01790750 · ClinicalTrials.gov registry record · NA

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

A NA study of Patent Ductus Arteriosus, sponsored by University of Florida.

Completed
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT01790750 is a NA study of Patent Ductus Arteriosus that has completed, run by University of Florida. The registered enrollment target is 50 participants, below the 275-participant average among 7 other Patent Ductus Arteriosus trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01790750, a NA study of Patent Ductus Arteriosus, has completed, sponsored by University of Florida.

COMPLETED
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DEVICE PES first, then FFES

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2013-02
Est. Completion 2013-05
Phase NA

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT01790750

The ClinicalTrials.gov registry entry for NCT01790750 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 275-participant average among 7 other Patent Ductus Arteriosus trials with a reported enrollment target (82% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Patent Ductus Arteriosus appearing as the primary indexed condition, and to 1 intervention - of which PES first, then FFES is the first listed.

NCT01790750 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01790750 about?

NCT01790750 is a clinical study titled "Pocket Echocardiography System (PES) for Detection of 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 ou...

What is the current status of trial NCT01790750?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2013-02. Estimated completion is 2013-05.

What conditions does trial NCT01790750 study?

This clinical trial studies the following conditions: Patent Ductus Arteriosus.

What interventions are being tested in trial NCT01790750?

The interventions under investigation include: PES first, then FFES (DEVICE).

Who is sponsoring clinical trial NCT01790750?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01790750 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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