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

April 10, 2026 updated by: Northwestern Medicine
This study aims to see how well a non-contact EKG compares to the EKG currently used in the special care nursery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Lake Forest, Illinois, United States, 60045
        • Northwestern Lake Forest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern Medicine

Collaborators

Northwestern Lake Forest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 20-006-LFH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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