Multi-center non-inferiority study of the monitoring performance of the BAMBI BELT; a wireless device measuring neonatal heart rate, ECG and respiration based on diaphragmatic electromyography
Completed
- Conditions
- cardio-respiratory instabilityPrematurity10028920
- Registration Number
- NL-OMON50960
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 39
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints are a) equivalence of heart rate monitoring (as measured<br /><br>by i) second-to-second correlation and level of agreement, and ii) bradycardia<br /><br>and tachycardia sensitivity and positive predictive value (PPV)) and b) safety<br /><br>(as measured by data loss and pre-defined relevant adverse events and adverse<br /><br>device effects). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are equivalence of respiratory monitoring, and the visual<br /><br>interpretability of waveforms (ECG and respiration waveforms) as rated by<br /><br>independent, blinded experts.</p><br>