Electrocardiogram Electrode Site ReactionNCT04269044
The Efficacy of a Novel, Non-contact EKG in the NICU
An observational study of Electrocardiogram Electrode Site Reaction, run by Northwestern Medicine at 1 site in United States.
Trial summary
This study aims to see how well a non-contact EKG compares to the EKG currently used in the special care nursery. Read more about this study
- Who is it for?
- Ages 0 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Electrocardiogram Electrode Site Reaction
- What is being tested?
- non-contact EKG
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 30 days
- All sexes
- Healthy volunteers accepted
- 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
Who may be able to join
- Apgar at 5 min >/= 7
- Admitted to the NICU
- Indication for standard EKG monitoring
Who cannot join
- Apgar < 7 at 5 min
- Not in the NICU
- Not being monitored with standard EKG monitors
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Lake Forest Hospital
Lake Forest, Illinois, 60045
About this study
This study aims to see how well a non-contact EKG compares to the EKG currently used in the special care nursery.
Read the 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.
- Being tested
- non-contact EKG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-contact EKGDiagnostic test
Also called standard, contact EKG
ultra-sensitive, non-contact EKG pad will be placed beneath the infant
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in heart rate
we will compare the two heart rate figures from both EKG sources
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start8 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: The PI is no longer with the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrocardiogram Electrode Site ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Lake Forest Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269044
- Sponsor's protocol ID
- 20-006-LFH
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Novel, Non-contact EKG in the NICU
- ClinicalTrials.gov ID
- NCT04269044
- Acronym / sponsor ID
- 20-006-LFH
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI is no longer with the institution.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northwestern MedicineUniversity, hospital or other
- Collaborators
- Northwestern Lake Forest Hospital
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- Apgar at 5 min >/= 7
- Admitted to the NICU
- Indication for standard EKG monitoring
Key exclusion criteria (3 listed)
- Apgar < 7 at 5 min
- Not in the NICU
- Not being monitored with standard EKG monitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-contact EKGAlso: standard, contact EKGultra-sensitive, non-contact EKG pad will be placed beneath the infant | Diagnostic test | – |
Primary outcome
difference in heart rate
Time frame: 1 hour
we will compare the two heart rate figures from both EKG sources
Results and safety
The study was stopped early (reason given: The PI is no longer with the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Electrocardiogram Electrode Site Reaction
Recruiting
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
Sudden Unexplained Infant Death, Apnea of Newborn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrocardiogram Electrode Site Reaction, run by Northwestern Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The PI is no longer with the institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in heart rate (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.