AWARD – Wireless Sensors for Newborns

Why are we conducting this study?

After birth, babies are monitored so that changes in breathing, pulse, or oxygen saturation can be detected early.

Currently, this monitoring is usually done with devices connected to the baby via multiple cables.

New wireless sensors could make this monitoring easier while also allowing for closer contact between parents and their baby, especially during early skin-to-skin contact.

In this study, we aim to investigate whether these new sensors measure just as reliably and safely as the current standard devices.

Study Objective

The results may help to:

• Improve the monitoring of newborns

• Make medical devices easier to use

• Allow for closer contact between parents and their baby

How participation works

If you agree to participate, during the first two hours after birth, your baby’s vital signs will be measured simultaneously with two systems: the new wireless sensors and the usual medical devices.

No additional examinations are required.

Procedure

1. Immediately after birth
Two small wireless sensors are gently attached to your baby’s skin.
Your baby can remain with you during this time.

2. Early skin-to-skin contact
Your baby stays in your arms or on your chest.
The sensors measure breathing, pulse, body temperature, and oxygen saturation.

3. After approximately 20 minutes
An additional standard monitoring device with cables will be attached.
This device is routinely used in clinical care.

4.Monitoring for two hours
Both systems measure your baby’s vital signs simultaneously.
Medical care continues according to standard clinical procedures.

5.Short questionnaire for parents
After participation, we ask you to complete a short questionnaire.
It asks about your impressions of using the sensors and the skin-to-skin contact.
The questionnaire helps us better understand parents’ experiences.

6.End of participation
After approximately two hours, the sensors are removed.
This marks the end of your baby’s participation in the study.

Risks

The risks are very low.

The sensors are attached to the skin and may occasionally cause slight skin redness. This usually disappears on its own after a short time.

No pain or additional burden for your baby is expected.

Voluntary Participation

Participation in the study is voluntary.

You may decide at any time, without giving a reason, that your baby should not participate or that participation should be stopped.

Your baby’s medical care will remain completely unaffecte

Frequently Asked Questions about the Study

Does my baby benefit directly?
Your baby does not receive a direct medical benefit from participating. The study aims to investigate new technologies for monitoring newborns. However, the results may help improve care for future babies.

Will my baby undergo additional examinations?
No. Only sensors that measure vital signs are applied. There are no blood tests or other additional examinations.

Who has access to the data?
The data is stored in encrypted form. Personal information is replaced with a code, so your baby cannot be directly identified. Only authorized members of the study team have access to the data within the scope of the study.

Can I withdraw my consent later?
Yes. You can decide at any time, without giving a reason, to stop participation. Your baby’s medical care will remain completely unaffected.

Results

After the study is completed, the scientific findings and results will be published here.