N/A
N=50
Pocket Echocardiography System (PES) for Detection of PDA in Neonates
Patent Ductus Arteriosus
Bottom Line
View on ClinicalTrials.gov: NCT01790750 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) — 10.8 percentage of false positives
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PES first, then FFES (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) |
10.8 | — |
| PRIMARY False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) |
3.75 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01790750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.