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.

Measuring vital signs in young children participating in medical-scientific
studies is often time consuming, e.g., because of frequent visits to a doctor
or clinic, and can be stressful for the child and its parents. The ability to
monitor the vital signs using a simple technology connected to digital devices
can alleviate stress for both the child and its parents. It can also result in
the possibility to monitor the situation of a child when outside the hospital
setting.

The Sponsor is investigating the possibilities to use 2 combinations of
technologies for easier monitoring of vital signs.

LSP/NWO
The LSP system consists of is 2 adhesive plasters, 1 on the front of the chest
and 1 in the armpit, with sensors. The NWO system is a wristband with a sensor
over a finger. The sensors relay the measurements to an app on a tablet.

MSB/OSS
The MSB is a button that is attached to the child*s clothes that measures
activity and respiratory frequency. It is combined with the OSS which is an
elastic sock with a sensor. Both devices are connected to a mobile phone which
collects.

The purpose of this study is to investigate how well 2 combinations of devices
for continuous monitoring of vital signs (in this case pulse rate, breathing
frequency, peripheral oxygen saturation [SpO2], and skin temperature) work when
used in healthy children aged 0 to 36 months. The systems used are:

• the Isansys Lifetouch Blue Continuous Cardiac Sensor and Lifetemp Continuous
Clinical Thermometer with Patient Status Engine (LSP) combined with the Nonin
WristOx2® Pulse Oximeter Model 3150 (NWO)
• a combination of MonBaby Smart Button (MSB) and Owlet Smart SockTM (OSS).

Both combinations and the individual systems, are compared with the current
standards for measuring vital signs in this age group.

It will also be investigated how easy the systems are to use and what the
impression is about the acceptance of the system used by the child.

We will first evaluate whether the child may participate. The responsible
doctor will perform a short physical examination, and will measure the number
of breaths per minute, heart rate, SpO2 and body temperature. The responsible
doctor will also ask about the medical history of the child. These factors are
important for the study because they can influence the results of the
measurements.

The actual study will consist of measurements that will be performed during a
period of 2 hours.

Whether the measurements will be performed using the LSP/NWO combination or the
MSB/OSS combination will be determined by chance. Ten children will be
monitored using the LSP/NWO combination and 10 using the MSB/OSS combination,
meaning that you will have 50% chance to have either one of the systems.

During the study, the following will take place:
• We will ask about the wellbeing of the child and if there are details about
his/her health
• We will do a physical examination
• We will measure the vital signs of the child
• We will ask to complete a questionnaire about how the parent and the child
feel about the measuring methods used.

The LSP systems and the standard method use adhesive plasters which may lead to
skin irritation (rash and itching) during or after use.