Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
Primary Purpose
Congenital Heart Disease in Children
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable Vital Signs Monitoring Device
Sponsored by
About this trial
This is an interventional other trial for Congenital Heart Disease in Children
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Children's CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wearable Vital Signs Monitoring Device
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of a wearable monitoring device as determined by signal morphology
Feasibility of a wearable monitoring device as determined by signal-to-noise ratio
Feasibility of reusable electrodes as determined by the signal-to-noise ratio
Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05910320
Brief Title
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
Official Title
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
May 23, 2024 (Anticipated)
Study Completion Date
May 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease in Children
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wearable Vital Signs Monitoring Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Wearable Vital Signs Monitoring Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of a wearable monitoring device as determined by signal morphology
Time Frame
From device placement to removal, up to 1 hour
Title
Feasibility of a wearable monitoring device as determined by signal-to-noise ratio
Time Frame
From device placement to removal, up to 1 hour
Title
Feasibility of reusable electrodes as determined by the signal-to-noise ratio
Time Frame
From electrode placement to removal, up to 15 minutes
Title
Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors
Time Frame
From device placement to removal, up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Calligy, BSN
Phone
4432874117
Email
kcummi15@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Gottlieb Sen, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Calligy, BSN
Phone
443-287-4117
Email
kcummi15@jhmi.edu
12. IPD Sharing Statement
Learn more about this trial
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
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