Prematurity
Conditions
Interventions
Additional (non-invasive) monitoring with a wireless, wearable, biocompatibile belt
Sponsors
Máxima Medical Center (participating center: Amsterdam Medical Center)
Eligibility
Inclusion criteria
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, 37 weeks)
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary endpoints are equivalence of respiratory monitoring, and the visual interpretability of waveforms (ECG and respiration waveforms) as rated by independent, blinded experts. | — |
Contacts
Public ContactDeedee Kommers
Máxima Medical Center
Outcome results
None listed