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

NCT04269044 | Terminated

• 1 other identifier: 20-006-LFH
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Electrocardiogram Electrode Site Reaction

Outcome Measures

Primary Outcomes (1)

• difference in heart rate

  we will compare the two heart rate figures from both EKG sources

  1 hour

Interventions

non-contact EKG DIAGNOSTIC_TEST

ultra-sensitive, non-contact EKG pad will be placed beneath the infant

Also known as: standard, contact EKG

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern Medicine: lead
• Northwestern Lake Forest Hospital: collaborator

Study Sites (1)

Northwestern Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: September 8, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 15, 2026

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)