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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01790750
First received: February 11, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Patent Ductus Arteriosus
Device: PES first, then FFES

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pocket Echocardiography System (PES) for Detection of Patent Ductus Arteriosus (PDA) in Neonates

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false positives between the two systems.

  • False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false negatives between the two systems.


Enrollment: 50
Study Start Date: February 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PES first, then FFES
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.
Device: PES first, then FFES
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.
Other Names:
  • Pocket echocardiography system scan
  • Full Featured Echocardiography System Scan

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.

  Eligibility

Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790750

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Curt DeGroff, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01790750     History of Changes
Other Study ID Numbers: IRB201200340
Study First Received: February 11, 2013
Results First Received: January 15, 2014
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
PDA
Echo
PES
Handheld echo system

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 01, 2014