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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01790750
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 2.9
• Patients Per Site Per Month: 17.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Device: PES first, then FFES	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Pocket Echocardiography System (PES) for Detection of Patent Ductus Arteriosus (PDA) in Neonates
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

1. False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) [at baseline]

   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.

2. False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) [at baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 90 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Curt DeGroff, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01790750
• Other Study ID Numbers: IRB201200340
• First Posted: Feb 13, 2013
• Last Update Posted: Apr 11, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by University of Florida: PDA; Echo; PES; Handheld echo system
• Additional relevant MeSH terms: Ductus Arteriosus, Patent

Study Results

Participant Flow

Recruitment Details	Patients recruited in the NICU.

Arm/Group Title	PES First, Then FFES
Arm/Group 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.
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PES First, Then FFES
Arm/Group 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.
Overall Participants	50
Age (Count of Participants)
<=18 years	50 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	34.8 (4.98)
Sex: Female, Male (Count of Participants)
Female	17 34%
Male	33 66%
Region of Enrollment (participants) [Number]
United States	50 100%
Body Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	2.470 (1.157)

Outcome Measures

1. Primary Outcome

Title	False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)
Description	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.
Time Frame	at baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PES First, Then FFES
Arm/Group Description	A 5-minutePocket 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.
Measure Participants	50
Mean (Standard Deviation) [percentage of false positives]	10.8 (1.2)

2. Primary Outcome

Title	False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)
Description	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.
Time Frame	at baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PES First, Then FFES
Arm/Group 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.
Measure Participants	50
Mean (Standard Deviation) [percentage of false negative]	3.75 (4.63)

Adverse Events

Time Frame	Adverse event data was collected for 3 months.
Arm/Group Title	PES First, Then FFES
Arm/Group 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.
All Cause Mortality
	PES First, Then FFES
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PES First, Then FFES
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	PES First, Then FFES
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.