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

The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.

Study Overview

• Status: Terminated
• Conditions: Congenital Heart Disease in Children
• Intervention / Treatment: Device: Wearable Vital Signs Monitoring Device

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Children's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wearable Vital Signs Monitoring Device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signal morphology of wearable monitoring device	Feasibility of a wearable monitoring device as determined by signal morphology of wearable monitoring device	From device placement to removal, up to 1 hour
Signal-to-noise ratio of wearable monitoring device	Feasibility of a wearable monitoring device as determined by signal-to-noise ratio	From device placement to removal, up to 1 hour
Signal-to-noise ratio of reusable electrodes	Feasibility of reusable electrodes as determined by the signal-to-noise ratio	From electrode placement to removal, up to 15 minutes
Percent error of wearable monitoring device compared to clinical bedside monitors	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Danielle Gottlieb Sen, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): June 24, 2025
• Study Completion (Actual): June 24, 2025

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: IRB00361015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No