A PHASE 0, NON-INTERVENTIONAL, NON-INVESTIGATIONAL MEDICINAL PRODUCT, EARLY TECHNOLOGY EXPLORATION STUDY WITH CONNECTED DIGITAL DEVICES FOR SEMI-CONTINUOUS COLLECTION OF VITAL SIGNS IN A HEALTHY PEDIATRIC POPULATION.

Completed

• Conditions: iet van toepassing; Not applicable.

• Registration Number: NL-OMON46008
• Lead Sponsor: Janssen Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

healthy children
0 - 36 months

Exclusion Criteria

Previous participation in the current study.
The subject is participating in drug interventional studies.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare Leman Micro Devices, health sensing solution for smartphones (LMD)<br /><br>with gold standards for vital signs assessments<br /><br><br /><br>To compare Isansys Lifetouch Smart Patch Cardiac Sensor with Patient Status<br /><br>Engine (LSP) with gold standards for vital signs assessments</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the engineering support of LMD</p><br>