To collect reference data of dEMG in neonates to use for testing the Bambi Belt B.V. algorithm which is under development.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Monitoring van ademhalingsfrequentie (en hartfrequentie) in neonaten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To collect sufficient reference data of dEMG in neonates, in a representative
population and for specific routine caregiving scenarios, to use for testing
and optimizaton of the Bambi Belt B.V. algorithm.
Secondary outcome
Not applicable
Background summary
In preterm infants, respiration is currently measured using chest impedance
(CI). Whilst proven to be a useful method, CI has important limitations, such
as inaccuracies in monitoring respiration due to cardiac interference and
nonbreathing-related chest wall movement. Respiration can also be determined by
directly measuring the electrical activity (electromyography) of the diaphragm
(dEMG). Bambi Belt B.V., a Dutch med-tech company, aims to market a product
that measures dEMG in neonates specifically. To assess the functioning of this
new device and improve the algorithm used in this device, neonatal reference
data including dEMG data has to be obtained with a CE-certified medical device,
such as the Delsys Trigno Wireless Biofeedback System.
Study objective
To collect reference data of dEMG in neonates to use for testing the Bambi Belt
B.V. algorithm which is under development.
Study design
Observational within-subject explorative study.
Study burden and risks
The results of this study will have no direct benefit to the patient because
the study is observational. The dEMG recordings are not available for guiding
care. This is a non-invasive, observational study in which infants will wear an
additional monitoring device with minimal risks. This study needs to be
conducted in infants, since this is the population of intended use for the new
monitoring device.
Henri Dunantstraat 1
Den Bosch 5223GZ
NL
Henri Dunantstraat 1
Den Bosch 5223GZ
NL
Listed location countries
Age
Inclusion criteria
Gestational age 26 - 42 weeks
Written parental informed consent
Exclusion criteria
-Patients requiring defibrillation. The device should be removed prior to start
of defibrillation -Patients with implanted electronic devices of any kind,
including cardiac pace-makers or similar assistive devices, electronic infusion
pumps and implanted stimulators
-Patients with irritated skin or open wounds or with allergies to Silver . In
case skin irritation or discomfort occurs, use of device must be discontinued.
-Patients requiring diagnostic imaging (X-thorax, MRI, cardiac ultrasonography)
during the study
-Unsuitability for an informed consent conversation; e.g. timewise or
attention-wise too much of a burden for parents
-Patients with parents who do not speak and/or read the native language or
English
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73458.028.20 |