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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05910320
Other study ID # IRB00361015
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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