No registrations found.
ID
Source
Brief title
Health condition
Prematurity
Sponsors and support
Intervention
Outcome measures
Primary outcome
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. In this study, the aim is to establish non-inferiority of the monitoring performance of an alternative, wireless monitoring device.
Study objective
The monitoring performance of a wireless alternative for cardiorespiratory monitoring in neonates is equivalent (non-inferior) compared to routine monitoring with adhesive electrodes.
Study design
Additional monitoring with the belt is performed for 24 hours continuously. The study ends after these 24 hours, there is no follow up.
Intervention
Additional (non-invasive) monitoring with a wireless, wearable, biocompatibile belt
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 that is not already fully represented in the study (to include a representative sample, inclusion is performed in three cohorts, <28 weeks, between 28-37 weeks, > 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
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9480 |
| Other | METC MMC : W21.042 |