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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PES first, then FFES | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PES first, then FFES | Device | 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 | Description | Time Frame |
|---|---|---|
| False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) | 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. | at baseline |
| False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) | 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. | at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Curt DeGroff, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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Patients recruited in the NICU.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) | 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. | Posted | Mean | Standard Deviation | percentage of false positives | at baseline |
|
|
Adverse event data was collected for 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Curt DeGroff | University of Florida | (352) 273-7831 | degroffc@peds.ufl.edu |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Weight | Mean body weight | Mean | Standard Deviation | kg |
|
| Counts |
|---|
| Participants |
|
|
| Primary | False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) | 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. | Posted | Mean | Standard Deviation | percentage of false negative | at baseline |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |