NCT05910320

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

June 9, 2023

Last Update Submit

July 7, 2025

Conditions

Congenital Heart Disease in Children

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Wearable Vital Signs Monitoring Device

EXPERIMENTAL
Device: Wearable Vital Signs Monitoring Device

Interventions

Wearable Vital Signs Monitoring DeviceDEVICE

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.

Wearable Vital Signs Monitoring Device

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU)
  • Parent provided written informed consent

You may not qualify if:

  • Foster or ward of the state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

Study Officials

  • Danielle Gottlieb Sen, MD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

May 23, 2023

Primary Completion

June 24, 2025

Study Completion

June 24, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations

US(1)