Apnea of Prematurity breathing pauses
Conditions
Interventions
Within this study the only intervention is the measurement of diaphragm 
activity with three surface electrodes for to 8 hours, in order to record 
several apnea periods.
Sponsors
Academisch Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: - Gestational age (GA) between 26 and 32 weeks - Receiving non-invasive respiratory support in the form of: o High-flow nasal cannula (HFNC) o Nasal continuous positive pressure (nCPAP) o Non-invasive Positive Pressure Ventilation (nIPPV) - Parental/guardian informed consent
Exclusion criteria
Exclusion criteria: - Congenital anomalies that prevent the execution of a dEMG measurement - (indication for) Abdominal surgery that prevents the execution of a dEMG measurement - End of life decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity/Specificity of the developed apnoea detection algorithm (based on the measurements made), relative to the gold standard. The standard here concerns the clinical evaluation, with the clinical expert himself determining whether and if so what type of apnoea is present. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity/specificity for distinguishing the different types of apnoea (central, obstructive, mixed). Moreover,ability to use dEMG data to observe changes in diaphragm activity over time, among others during changes in respiratory support, will be studied. In addition, information on the functionality of the SERA will be collected using the measurement signal itself (i.e. to observe the occurrence of a loss of Bluetooth connection and the amount of time with an electrode off) and using a short survey to acquire the clinical opinion of the treating nurses considering the ease-of-use of the SERA device. | — |
Countries
Netherlands
Outcome results
None listed