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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
No Placebo-Only Group
Summary
This trial is testing a new wearable device that monitors vital signs in infants. It aims to help infants with heart conditions and healthy infants by providing continuous health data and alerts for any issues. The goal is to improve survival rates and overall health outcomes.
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.
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.
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 belowSelect...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent error of wearable monitoring device compared to clinical bedside monitors
Signal morphology of wearable monitoring device
Signal-to-noise ratio of reusable electrodes
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Wearable Vital Signs Monitoring DeviceExperimental Treatment1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and pharmacotherapy. Surgical interventions, such as open-heart surgery, correct structural defects, improving blood flow and heart function.
Catheter-based procedures, like balloon angioplasty, widen narrowed vessels or repair defects without open surgery. Pharmacotherapy, including diuretics, beta-blockers, and ACE inhibitors, helps manage symptoms and prevent complications by controlling blood pressure, reducing fluid buildup, and improving heart efficiency.
Continuous monitoring of vital signs is crucial for CHD patients as it allows for early detection of complications, timely interventions, and better management of the disease, ultimately improving outcomes and quality of life.
Let us use the pulmonary artery catheter correctly and only when we need it.
Let us use the pulmonary artery catheter correctly and only when we need it.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,586 Total Patients Enrolled
Danielle Gottlieb Sen, MDPrincipal InvestigatorJohns Hopkins School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am admitted to the newborn, pediatric cardiac ICU, or pediatric care unit.
Research Study Groups:
This trial has the following groups:- Group 1: Wearable Vital Signs Monitoring Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.