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.

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. - Pediatric vital signs collection study in children.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46008

Enrollment

Registered

2018-11-27

Start date

2018-11-30

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Niet van toepassing Not applicable.

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: healthy children 0 - 36 months

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To compare Leman Micro Devices, health sensing solution for smartphones (LMD) with gold standards for vital signs assessments To compare Isansys Lifetouch Smart Patch Cardiac Sensor with Patient Status Engine (LSP) with gold standards for vital signs assessments	—

Secondary

Measure	Time frame
To evaluate the engineering support of LMD	—

Countries

Netherlands

Outcome results