SERA - Surface Electromyography for Respiration and Apnea monitoring in preterm infants

A large proportion of preterm infants admitted to the Neonatology ICU have
so-called apnoeas, breathing stops that originate from the underdevelopment of
the respiratory centre. This is therefore also called Apnoea of Prematurity
(AOP). The number of these incidents is initially low, increases in the second
week of life, then stabilises in the 3rd/4th week of life and the number of
incidents decreases again. Despite the fact that in the majority of children,
apnoeas disappear with time, detecting them and treating them, does matter.
During an apnoea, oxygen levels in the blood may drop and the heart rate may
also react to this. Research shows that these moments of hypoxia (too low
amount of oxygen) can be detrimental to child development in the long term.
However, accurate apnoea detection and classification has so far proved
difficult. This makes treatment reactive and less proactive. There is still
much scope for improving patient monitoring to thereby reduce the number of
apnoeas and their negative effects.
Measurements of the muscle activity of the diaphragm provide direct insight in
respiration and could therefore be used to detect and classify apnea. The SERA
device can measure the diaphragm activity and is the successor of the Dipha-16
device, as the Dipha-16 is no longer for sale and is considered end-of-life.
The SERA is identical to the Dipha-16 with respect to the signal acquisition
and amplification. The SERA contains new firmware and is therefore different in
terms of signal analysis. The to be developed apnea detection algorithm in this
study is aimed to be integrated within the SERA device. Therefore, the SERA
hardware, combined with the software algorithm are considered the
investigational product.

The aim of this study is to use diaphragmatic muscle activity measurements in
premature neonates to develop an algorithm that can quickly identify that the
patient has apnoea and then classify it by type (obstructive, central or
mixed). This could provide more insight into the patient's respiratory
condition and then guide treatment.

It is a mono-centre prospective observational cohort study, in two phases.

Within this study the only intervention is the measurement of diaphragm
activity with three surface electrodes for to 8 hours, in order to record
several apnea periods.

This study uses only non-invasive measurement instruments and does not change
anything about the standard care the patient receives. Although the
measurements will take several hours, the burden on the patient is minimal. In
addition, the electromyography technique used has been used in research for
many years, with no adverse effects on the patient.