Congenital Heart Disease in ChildrenNCT05910320
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
A study testing Wearable Vital Signs Monitoring Device in people with Congenital Heart Disease in Children, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Congenital Heart Disease in Children
- What is being tested?
- Wearable Vital Signs Monitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 24 Jun 2025
- Phase
- Interventional
- 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 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU)
- Parent provided written informed consent
Who cannot join
- Foster or ward of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
About this study
The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.
Read the detailed description
Vital sign monitoring of infants outside of a traditional healthcare setting has already been shown to significantly decrease mortality for children with single ventricle congenital heart disease (1V CHD), a fragile group of patients with congenital heart disease (CHD). Therefore, there is a critical need to develop an accurate, at-home vital sign monitoring system for infants to expand the benefits of remote monitoring to further patient populations. The investigators believe that allowing for continuous monitoring at a clinical standard with interpretations and alerts built into the technology will result in an even greater decline in mortality for infants with 1V CHD, improved clinical outcomes for all infants with CHD, and increased well-being for healthy infants.
To achieve this goal, the investigators are developing a health monitoring system that collects numerical data and physiological waveforms describing heart rate (HR), respiratory rate (RR), pulse oximetry (SpO2), regional oxygen saturation, temperature, and infant motion.
- Conditions
- Congenital Heart Disease in Children
- Being tested
- Wearable Vital Signs Monitoring Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Vital Signs Monitoring DeviceDevice
The prototype will be used to non-invasively measure vital signs. This prototype (preliminary version) is composed of a sensor module, a rechargeable battery, and electrodes. The device is housed in a waterproof, silicone casing.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Vital Signs Monitoring Device | Experimental | Not described Receives: Device: Wearable Vital Signs Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal morphology of wearable monitoring device
Feasibility of a wearable monitoring device as determined by signal morphology of wearable monitoring device
Measured: From device placement to removal, up to 1 hour
Signal-to-noise ratio of wearable monitoring device
Feasibility of a wearable monitoring device as determined by signal-to-noise ratio
Measured: From device placement to removal, up to 1 hour
Signal-to-noise ratio of reusable electrodes
Feasibility of reusable electrodes as determined by the signal-to-noise ratio
Measured: From electrode placement to removal, up to 15 minutes
Percent error of wearable monitoring device compared to clinical bedside monitors
Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors
Measured: From device placement to removal, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start23 May 2023
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Why it stopped: Closed at site. Investigator no longer at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Gottlieb Sen, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910320
- Sponsor's protocol ID
- IRB00361015
- Status last verified
- Jul 2025
- First submitted
- 9 Jun 2023
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
- ClinicalTrials.gov ID
- NCT05910320
- Acronym / sponsor ID
- IRB00361015
- Conditions
- Congenital Heart Disease in Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed at site. Investigator no longer at site.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 18 Jun 2023 (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.
The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.
Detailed description
Vital sign monitoring of infants outside of a traditional healthcare setting has already been shown to significantly decrease mortality for children with single ventricle congenital heart disease (1V CHD), a fragile group of patients with congenital heart disease (CHD). Therefore, there is a critical need to develop an accurate, at-home vital sign monitoring system for infants to expand the benefits of remote monitoring to further patient populations. The investigators believe that allowing for continuous monitoring at a clinical standard with interpretations and alerts built into the technology will result in an even greater decline in mortality for infants with 1V CHD, improved clinical outcomes for all infants with CHD, and increased well-being for healthy infants.
To achieve this goal, the investigators are developing a health monitoring system that collects numerical data and physiological waveforms describing heart rate (HR), respiratory rate (RR), pulse oximetry (SpO2), regional oxygen saturation, temperature, and infant motion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable Vital Signs Monitoring Device | Experimental | Device: Wearable Vital Signs Monitoring Device |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU)
- Parent provided written informed consent
Key exclusion criteria (1 listed)
- Foster or ward of the state
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 |
|---|---|---|
| Wearable Vital Signs Monitoring DeviceThe prototype will be used to non-invasively measure vital signs. This prototype (preliminary version) is composed of a sensor module, a rechargeable battery, and electrodes. The device is housed in a waterproof, silicone casing. | Device | Wearable Vital Signs Monitoring Device |
Primary outcome
Signal morphology of wearable monitoring device
Time frame: From device placement to removal, up to 1 hour
Feasibility of a wearable monitoring device as determined by signal morphology of wearable monitoring device
Signal-to-noise ratio of wearable monitoring device
Time frame: From device placement to removal, up to 1 hour
Feasibility of a wearable monitoring device as determined by signal-to-noise ratio
Signal-to-noise ratio of reusable electrodes
Time frame: From electrode placement to removal, up to 15 minutes
Feasibility of reusable electrodes as determined by the signal-to-noise ratio
Percent error of wearable monitoring device compared to clinical bedside monitors
Time frame: From device placement to removal, up to 1 hour
Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors
Results and safety
The study was stopped early (reason given: Closed at site. Investigator no longer at site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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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.
Danielle Gottlieb Sen, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Vital Signs Monitoring Device in people with Congenital Heart Disease in Children, run by Johns Hopkins University 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 2 inclusion and 1 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 10 Jul 2025. 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: Closed at site. Investigator no longer at site.). 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?
Signal morphology of wearable monitoring device (time frame: From device placement to removal, up to 1 hour). The study lists 4 primary outcomes in all. 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 10 Jul 2025.