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

Congenital Heart Disease in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910320
• Other study ID #: IRB00361015
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: May 23, 2025

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: Kate Calligy, BSN
• Phone: 4432874117
• Email: kcummi15[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 23, 2025
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Year

Eligibility

Inclusion Criteria:

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

• Parent provided written informed consent

Exclusion Criteria:

• Foster or ward of the state

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Children's Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a wearable monitoring device as determined by signal morphology		From device placement to removal, up to 1 hour
Primary	Feasibility of a wearable monitoring device as determined by signal-to-noise ratio		From device placement to removal, up to 1 hour
Primary	Feasibility of reusable electrodes as determined by the signal-to-noise ratio		From electrode placement to removal, up to 15 minutes
Primary	Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors		From device placement to removal, up to 1 hour