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

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 - Monitoring performance of the Bambi belt

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50960

Enrollment

Registered

2021-05-21

Start date

2021-07-15

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardio-respiratory instability Prematurity

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

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 (PMA) cohort that is not already fully represented in the study (to include representative numbers, inclusion is performed based on three cohorts, PMA 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
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

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.	—

Countries

Netherlands

Outcome results