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Wearable Device

Wearable Vital Signs Monitor for Infant Health Monitoring

N/A

Recruiting

Led By Danielle Gottlieb Sen, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU)

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from electrode placement to removal, up to 15 minutes

Awards & highlights

Study Summary

This trial looks at using a device to monitor vital signs in infants to see if it's a feasible option.

Who is the study for?

This trial is for infants with heart conditions who are in the newborn nursery, pediatric cardiac ICU, or pediatric care unit. Parents must consent to their child's participation. Infants under state guardianship (foster or ward) cannot participate.Check my eligibility

What is being tested?

The study is testing a new wearable device that monitors vital signs like heart rate and breathing in babies with heart disease to see if it works well and is easy to use.See study design

What are the potential side effects?

Since this trial involves monitoring with a wearable device, there may be minimal side effects such as potential skin irritation from the device. No significant medical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am admitted to the newborn, pediatric cardiac ICU, or pediatric care unit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from electrode placement to removal, up to 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from electrode placement to removal, up to 15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and from electrode placement to removal, up to 15 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors

Feasibility of a wearable monitoring device as determined by signal morphology

Feasibility of a wearable monitoring device as determined by signal-to-noise ratio

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Wearable Vital Signs Monitoring DeviceExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,452 Total Patients Enrolled

Danielle Gottlieb Sen, MDPrincipal InvestigatorJohns Hopkins School of Medicine

Media Library

Investigational Wearable Vital Signs Monitoring Device (Wearable Device) Clinical Trial Eligibility Overview. Trial Name: NCT05910320 — N/A

Congenital Heart Disease Research Study Groups: Wearable Vital Signs Monitoring Device

Congenital Heart Disease Clinical Trial 2023: Investigational Wearable Vital Signs Monitoring Device Highlights & Side Effects. Trial Name: NCT05910320 — N/A

Investigational Wearable Vital Signs Monitoring Device (Wearable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05910320 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for joining this experiment?

"The requirements to join this research are a diagnosis of congenital heart disease and being between 1 day old and 12 months. 45 participants in total will be accepted into the trial."

Answered by AI

Is the age criterion for participation in this trial limited to those below 75 years?

"According to the prerequisites for enrollment, potential trial participants must be between 1 day and 1 year old."

Answered by AI

Is enrollment currently available for this experiment?

"According to clinicaltrials.gov, this research is presently enrolling patients with the original posting date being May 23rd 2023 and most recent update occurring on June 9th 2023."

Answered by AI

How many individuals are contributing to this research endeavor?

"Affirmative, the clinicaltrials.gov page for this trial confirms its active recruitment of patients. This study was first advertised on May 23rd 2023 and is accepting 45 applicants to be tested at a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants

2023. "Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05910320.