To establish equivalence (non-inferiority) between monitoring performance of the Bambi Belt and the currently used cardio-respiratory monitoring device. The Bambi Belt is a potentially more patient friendly, wireless cardio-respiratory monitoring…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are a) equivalence of heart rate monitoring (as measured
by i) second-to-second correlation and level of agreement, and ii) bradycardia
and tachycardia sensitivity and positive predictive value (PPV)) and b) safety
(as measured by data loss and pre-defined relevant adverse events and adverse
device effects).
Secondary outcome
Secondary endpoints are equivalence of respiratory monitoring, and the visual
interpretability of waveforms (ECG and respiration waveforms) as rated by
independent, blinded experts.
Background summary
In sick or prematurely born neonates, monitoring of the heart rate, ECG, and
respiration is routinely performed using adhesive electrodes that obtain the
electrical activity of the heart and chest impedance. Especially in neonatal
intensive care units (NICUs), where all infants require monitoring, alternative
monitoring methods are desired to replace such obtrusive adhesive electrodes,
attached to hindering wires.
Study objective
To establish equivalence (non-inferiority) between monitoring performance of
the Bambi Belt and the currently used cardio-respiratory monitoring device. The
Bambi Belt is a potentially more patient friendly, wireless cardio-respiratory
monitoring device measuring diaphragmatic electromyography (dEMG).
Study design
Multicenter study in the Máxima Medical Center and Amsterdam Medical Center.
The study is of an observational within-subject design. Subjects will be
monitored with the Bambi Belt for 24 hours, in addition to standard monitoring.
Study burden and risks
Non-invasive, observational study in which infants have to wear an additional
monitoring device. Although unexpected, the risk of skin irritation due to this
device cannot be ruled out. There are no benefits for participating infants.
This study might demonstrate substantial benefits for a similar population in
the near future. These potential benefits outweigh the minimal risks.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
* Admitted to a participating NICU
* Being routinely monitored using adhesive electrodes for cardiorespiratory
monitoring
* Written parental informed consent
* Of a post-menstrual age (PMA) cohort that is not already fully represented in
the study (to include representative numbers, inclusion is performed based on
three cohorts, PMA < 28 weeks, PMA 28-37 weeks, PMA > 37 weeks)
Exclusion criteria
* Chest skin lesions preventing placement of electrode belt, since the intended
use of the belt is for intact skin.
* Congenital anomalies preventing placement of electrode belt
* (Effects of) surgery preventing or hindering belt placement, such as a
laparotomy or stoma
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 | NL77436.015.21 |