Trial Outcomes & Findings for Pocket Echocardiography System (PES) for Detection of PDA in Neonates (NCT NCT01790750)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

at baseline

Results posted on

2014-04-11

Participant Flow

Patients recruited in the NICU.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PES First, Then FFES n=50 Participants 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.
Age, Categorical <=18 years	50 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	34.8 weeks STANDARD_DEVIATION 4.98 • n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	33 Participants n=99 Participants
Region of Enrollment United States	50 participants n=99 Participants
Body Weight	2.470 kg STANDARD_DEVIATION 1.157 • n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PES First, Then FFES n=50 Participants 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.
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 Standard Deviation 1.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PES First, Then FFES n=50 Participants 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.
False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)	3.75 percentage of false negative Standard Deviation 4.63

Adverse Events

PES First, Then FFES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Curt DeGroff

University of Florida

Phone: (352) 273-7831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place