NCT05910320

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 1 Day – 1 Year
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Wearable Vital Signs Monitoring Device	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.

Timeline

• Start date: 2023-05-23
• Primary completion: 2025-06-24
• Completion: 2025-06-24
• First posted: 2023-06-18
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States