Demonstrate the suitability of cardiorespiratory monitoring directly after birth using a novel, wireless, non-adhesive device.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
neonatale monitoring
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
time to display HR after belt application.
Secondary outcome
ease of belt application, continuity and reliability of the monitor data
throughout the monitored period, and workflow and parent-infant interaction in
relation to the device throughout the monitored period as based on a limited
number of questions.
Background summary
The golden standard for HR measurement is HR obtained through adhesive ECG
electrodes. However, adhesive ECG electrodes have some disadvantages. They are
not suitable for use directly after birth (on a wet neonate), and the adhesives
can cause skin damage while the wires hinder parent-infant interaction and
staff workflow. Novel devices may provide a more suitable alternative for
cardiorespiratory monitoring directly after birth.
Study objective
Demonstrate the suitability of cardiorespiratory monitoring directly after
birth using a novel, wireless, non-adhesive device.
Study design
Prospective study investigating the suitability of wireless cardiorespiratory
monitoring with a wearable belt applied to unprepared skin directly after
birth. The study consists of a feasibility phase and a consecutive validation
phase (if monitoring on the unprepared skin appears feasible).
Study burden and risks
Non-invasive study in which newborn infants wear a new wireless
cardiorespiratory monitoring device directly after birth. During the study, the
monitor is turned to face the wall, and alarms (audible and visible) are
disabled, so obtained data are only analyzed retrospectively but not used
during the study. Although unexpected, the risk of skin irritation due to the
device cannot be ruled out whilst there are no potential benefits to the
participants. However, this study might demonstrate substantial benefits for a
similar population in the near future. Based on structured risk assessment, the
potential benefits therefore outweigh the minimal risks.
Henri Dunantstraat 1
Den Bosch 5223GZ
NL
Henri Dunantstraat 1
Den Bosch 5223GZ
NL
Listed location countries
Age
Inclusion criteria
• The baby (at the moment of consent still a fetus) will be born in the Jeroen
Bosch Hospital
• Without (prenatal) indication for cardiorespiratory monitoring
• With prenatal written informed consent from parents to participate in the
study (in Dutch)
Exclusion criteria
• Chest skin lesions at the site of the belt (the belt is intended for intact
skin).
• Congenital anomalies preventing placement of wearable belt, e.g. Siamese twins
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82020.028.22 |