Monitoring performance of a wireless belt for neonates
- Conditions
- Prematurity
- Registration Number
- NL-OMON23933
- Lead Sponsor
- Máxima Medical Center (participating center: Amsterdam Medical Center)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>b) Safety (as measured by data loss and pre-defined relevant adverse events and adverse device effects).
- Secondary Outcome Measures
Name Time Method Secondary endpoints are equivalence of respiratory monitoring, and the visual interpretability of waveforms (ECG and respiration waveforms) as rated by independent, blinded experts.