Patent Ductus ArteriosusNCT01790750
Pocket Echocardiography System (PES) for Detection of PDA in Neonates
A study testing PES first, then FFES in people with Patent Ductus Arteriosus, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- PES first, then FFES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All newborn infants with orders for cardiac echocardiography evaluation in clinically stable condition
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pocket Echocardiography System (PES) for Detection of Patent Ductus Arteriosus (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 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.
Read the 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.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- PES first, then FFES
- Keywords
- PDA, Echo, PES, Handheld echo system
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PES first, then FFESDevice
Also called Pocket echocardiography system scan, Full Featured Echocardiography System Scan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PES first, then FFES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Curt DeGroff, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790750
- Sponsor's protocol ID
- IRB201200340
- Status last verified
- Mar 2014
- First submitted
- 11 Feb 2013
- Last updated
- 11 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pocket Echocardiography System (PES) for Detection of Patent Ductus Arteriosus (PDA) in Neonates
- ClinicalTrials.gov ID
- NCT01790750
- Acronym / sponsor ID
- IRB201200340
- Conditions
- Patent Ductus Arteriosus
- Keywords
- PDA, Echo, PES, Handheld echo system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Posted 11 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PES first, then FFES | Other | Device: PES first, then FFESA 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. |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All newborn infants with orders for cardiac echocardiography evaluation in clinically stable condition
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PES first, then FFESAlso: Pocket echocardiography system scan, Full Featured Echocardiography System ScanA 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 |
Primary outcome
False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)
Time frame: 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.
False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curt DeGroff, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PES first, then FFES in people with Patent Ductus Arteriosus, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.