[For more information, contact John Vissers from Demcon Macawi]



Requirements & specifications

WP5 smartneonato

Contents

1. Project introduction. 3

2. System introduction. 5

2.1 Delivery context. 5

3. System design & usage. 7

3.1 System use scenarios & related (non) functional requirements. 7

3.2 System purpose & performance specifications. 7

3.3 State of the art. 8

4. System overview.. 15

5. regulatory, safety, security and legal needs. 15

Project introduction

This project is about a prototype system (at TRL6-7) that supports baby stability. The system consists of three subsystems:

Artificial Intelligence driven care coach. This supports the healthcare provider in his/her decision-making with near-real-time information and advice. These advices are generated by an AI analysis that analysis sensor data in the delivery room (from the existing systems and a new sensor patch).

A smart sensor patch for newborns. Existing patch technologies can harm the baby skin and have delayed/disrupted signals so there is a need for a new sensor patch for these newborns. Immediately at birth, the newborn baby receives this smart patch, from which heart rate, temperature and oxygen saturation can be measured accurately, user-friendly for the caregiver and stress-free for this kind. Because the data is quickly available, a quick(er) intervention is possible that can prevent permanent health damage. A new measurement realized by this patch is the baby's spontaneous (own) breathing activity using sEMG.

An innovative respiration module can be used to ventilate invasively and non-invasive synchronized with the baby. To synchronize with the baby, the respiration module is “triggered” based on spontaneous breathing activity in the patch. This can prevent long-term brain damage.

The smart patch and respiration module will be connected to a monitor, which functions as a central interface for the healthcare provider. Bidirectional communication is possible, so that the respiration module can be adjusted by the AI ​​system (partially and later completely in a closed loop). The monitoring system will be accessible via a Cloud connection. This allows specialist centers to monitor and advise on more complex stabilizations.

System introduction

This chapter provides general background information to understand the customer’s view on the scope of the project.

Delivery context

Preterm is defined as babies born alive before 37 weeks of pregnancy are completed. There are sub-categories of preterm birth, based on gestational age:

extremely preterm (less than 28 weeks)

very preterm (28 to less than 32 weeks)

moderate to late preterm (32 to 37 weeks).

Babies may be born preterm because of spontaneous preterm labour or because there is a medical indication to plan an induction of labour or caesarean birth early.

Source: https://www.who.int/news-room/fact-sheets/detail/preterm-birth

Once the baby is born, there are 3 location where the babies are resuscitated / taken care off:

• On the mother (skin to skin)

• Concorde table (cord clamping)

• At a certain distance on a "conventional" delivery table (e.g. 3 meter from mother or in separate room)

Below a typical “conventional” configuration of the medical equipment used for resuscitation after birth of the baby.

A typical configuration is a resuscitation table, platform to stabilize, heater, clock, resp support, FiO2 titration & plastic bag for temperature management (prematures <32wk).

Babies born <32 weeks are often put in a "sandwich baby bag" directly after birth to assure that the wet skin remains wet and that the temperature of the baby does not drastically decrease because of evaporation.

Ventilation in the delivery context is most often done with basic ventilation equipment. Later at a NICU more advanced tooling is added, although some hospitals also use more advance equipment at the delivery room but then there is the strategy that the equipment moves with the baby to the NICU as can be seen in below figure.

System design & usage

System use scenarios & related (non) functional requirements

Before, during and after the resuscitation multiple stakeholders are involved:

• Neonatologists

• Parents

• Nurses

• Students

Clinical physicians

Each of these stakeholders has their own needs for the system which will be captured in this section using (user) scenarios.

During the delivery of a pre-term typically the following persons have the following activities:

Doctor 1: airway management & ventilation

Doctor 2: Heart rate management & overall overview

Nurse 1: Pulse oxygenation & temperature

Nurse 2: Materials

Student: overall overview + notes

System purpose & performance specifications

The project has two development lines:

1. data flows and visualization

2. sensor patch and ventilation.

For development line 1:

During care, there is a need for a central presentation of data, which selectively shows the right data to the stakeholder at the right time (high frequency & real time). This requires parameters from different systems to be integrated, jointly interpreted and displayed based on decision rules.

An optimal presentation must be set up, which makes it possible to show trend views and hide irrelevant data.

For development line 2:

The primary goal with regard to ventilation is to develop non-invasive respiratory monitoring to trigger ventilation and/or to provide advice on (faster) reduction of ventilation. In the long term, closed-loop control of the ventilation system is the ultimate goal, but within the project timeframe a clinical decision support system is a more achievable goal.

An important point of attention within this development line is the development of a patch that is suitable for sensitive neonatal skin.

The following measurements are needed with their related performance specifications:

The list is based on the workshop results and the following article with an overview of developments in delivery room monitoring - including a survey among healthcare providers: The newborn delivery room of tomorrow: emerging and future technologies - PubMed (nih.gov):

What healthcare providers want according to the above article:

Left: Survey respondents’ (n= 60) ranking of the importance of key monitoring measures within the delivery room. Van <https://www.nature.com/articles/s41390-022-01988-y>

Right: survey ranking by respondents (n= 60) for new technology priorities within the delivery room of the future. Van <https://www.nature.com/articles/s41390-022-01988-y>

State of the art

Here an overview of state of the art (monitoring) equipment as used in the delivery context is given.

System overview

Classified

regulatory, safety, security and legal needs

• Outcomes of oxygen saturation targeting during delivery room stabilisation of preterm infants - PubMed (nih.gov)

• Innovations in Cardiorespiratory Monitoring to Improve Resuscitation With Helping Babies Breathe | Pediatrics | American Academy of Pediatrics (aap.org)

• Technology in the delivery room supporting the neonatal healthcare provider's task - PubMed (nih.gov)
• Reanimatieraad; HS 7 Richtlijnen 2021 (reanimatieraad.nl) (bewerking voor de Nederlandse situatie van de door de European Resuscitation Council (ERC) gepubliceerde richtlijn 2021: ‘European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth’)