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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2025-06-24

Brief Summary

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

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Detailed Description

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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.

Conditions

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Congenital Heart Disease in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Wearable Vital Signs Monitoring Device

Group Type EXPERIMENTAL

Wearable Vital Signs Monitoring Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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