MedTrace Logo

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

NCT05910320 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-07-10

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease in Children

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Danielle Gottlieb Sen, MD · Johns Hopkins School of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2025-06-24
Completion
2025-06-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05910320 on ClinicalTrials.gov