What side effects are associated with this type of intervention?

Common treatments for Congenital Heart Disease (CHD) include surgical interventions, medication management, and the use of implantable devices. Surgical interventions can lead to side effects such as infection, bleeding, and arrhythmias. Medications used to manage CHD, such as beta-blockers and diuretics, may cause side effects like dizziness, fatigue, and electrolyte imbalances. Implantable devices, such as pacemakers, can have complications including device malfunction, infection at the implantation site, and lead displacement. Continuous monitoring devices, while generally safe, may cause skin irritation or discomfort at the attachment site.

What prior FDA approvals exist?

The FDA has approved several treatments for Congenital Heart Disease (CHD), particularly focusing on managing complications such as pulmonary arterial hypertension (PAH). Sildenafil, a phosphodiesterase-5 inhibitor, has been approved for pediatric patients with PAH, although its use requires careful monitoring due to potential risks. Additionally, the FDA has approved various devices and medications aimed at continuous monitoring and management of CHD-related conditions, emphasizing the importance of regular assessment and monitoring of vital signs to optimize treatment outcomes.

What other types of research exist?

Promising novel alternatives to wearable vital sign monitoring devices for congenital heart disease patients in 2024 include: 1) Implantable cardiac monitors (ICMs) that provide continuous, real-time data on heart rhythms and other vital signs. 2) Advanced telemedicine platforms that integrate remote monitoring with AI-driven predictive analytics to detect early signs of complications. 3) Non-invasive sensors and patches that use photoplethysmography (PPG) and other technologies to monitor vital signs without the need for bulky equipment. 4) Smart home devices that can sync with medical-grade monitoring systems to provide comprehensive health data in a comfortable, familiar environment.

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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 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

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 more

Awards & 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

0 / 1Eligibility criteria met

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.