The Efficacy of a Novel, Non-contact EKG in the NICU | NCT04269044

Studies
The Efficacy of a Novel, Non-contact EKG in the NICU

NCT04269044

Sponsor

Northwestern Medicine

Status

Terminated

Last Update Posted

Apr 15, 2026Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Electrocardiogram Electrode Site Reaction

Interventions

non-contact EKG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The PI is no longer with the institution.

Expanded Access Info

Start Date

Sep 8, 2020Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Feb 11, 2020

First Submission Date that Met QC Criteria

Feb 11, 2020

First Posted Date

Feb 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2026

Last Update Posted Date

Apr 15, 2026Actual

Name	Class
Northwestern Lake Forest Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to see how well a non-contact EKG compares to the EKG currently used in the special care nursery.

Detailed Description

Current EKGs use sticky pads that attach to the skin, but these do not stick well to newborns under two days old and can cause skin irritation. Researchers are testing a new EKG system that works without stickers to see if it is accurate.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-contact EKG	Diagnostic Test	ultra-sensitive, non-contact EKG pad will be placed beneath the infant		standard, contact EKG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
difference in heart rate	we will compare the two heart rate figures from both EKG sources	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Apgar at 5 min >/= 7
Admitted to the NICU
Indication for standard EKG monitoring

Exclusion Criteria:

Apgar < 7 at 5 min
Not in the NICU
Not being monitored with standard EKG monitors

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

30 Days

Standard Ages

Child

Study Population

We will be studying neonates in the NICU. They have sensitive skin and thus a suspected benefit from switching to a non-contact EKG

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Lake Forest Hospital		Lake Forest	Illinois	60045	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided