Table 1.

Study eligibility criteria, endpoints, and definitions.

Eligibility criteria
Inclusion	Neonate with corrected age of < 28 days requiring admission to the high dependency unit at Pumwani Maternity Hospital for prematurity or other clinical indication(s) based on the attending physician’s assessment Caregiver(s) willing and able to provide informed consent and available for follow-up for the duration of the study
Exclusion	Receiving continuous positive airway pressure or mechanical ventilation Skin abnormalities in the nasopharynx and/or oropharynx Contraindication to skin sensor application Known arrhythmia Congenital abnormality requiring major surgical intervention Any medical or psychosocial condition or circumstance that would interfere with study conduct or for which study participation could put the neonate’s health at risk
Study endpoints
Up-time duration of EarlySense’s technology compared to the reference technology Diagnostic performance of EarlySense’s technology compared to the reference technology for clinical event detection including sensitivity, specificity, positive predictive value, negative predictive value, and ratio of false negative-to-false positive events Agreement between EarlySense’s technology and the reference technology for heart rate (HR) and respiratory rate (RR)
Study definitions
Total time attached	Measured in minutes as non-zero values recorded by the technology starting 10 min after technology placement and 5 min before disconnection; the 5-min periods before and after neonate removal from the mattress (EarlySense’s technology) or disconnection (reference technology) were also removed
Up-time	Measured in minutes as the total time the sensor was attached that met the a priori-identified adequate signal quality limits for each technology
Signal quality, high and adequate	HR EarlySense’s technology—high signal quality for every second, we evaluated the preceding 59 s in addition to the current second to ensure that at least 30 (50%) seconds demonstrated a proprietary HR signal quality index ≥ 70; adequate signal quality for every second, we evaluated the preceding 59 s in addition to the current second to ensure that at least 15 (25%) seconds demonstrated a proprietary HR signal quality index ≥ 25 Reference technology—for every second, we evaluated the preceding 59 s in addition to the current second to ensure that at least 30 (50%) seconds demonstrated a signal quality index (Masimo SQI) > 150 RR EarlySense’s technology—high signal quality for every second, we evaluated the preceding 59 s in addition to the current second to ensure that at least 42 (70%) seconds demonstrated a proprietary RR signal quality index ≥ 70; adequate signal quality for every second, we evaluated the preceding 59 s in addition to the current second to ensure that at least 15 (25%) seconds demonstrated a proprietary RR signal quality index ≥ 25 Reference technology—for every second, we evaluated the preceding 59 s in addition to the current second to ensure that at least 30 (50%) seconds demonstrated no capnography exceptions, indicating low RR quality (RR exceptions ≤ 1), and a capnography quality score ≥ 2
Event second	Any second that contains a high or low HR or RR event for either EarlySense’s technology or the reference technology
Event window	A 10-min window centered from 5 min before to 5 min after the first event second noted by the reference technology; no overlapping windows are allowed, so event seconds less than 5 min from the end of the previous event window result in the new event window starting immediately following the previous window
True positive event	Any reference technology event window containing at least 1 event second identified by EarlySense’s technology
False negative event	A reference technology event window containing no event seconds recorded by EarlySense’s technology
False positive event	An event recorded by EarlySense’s technology outside the reference technology’s event window
True negative event	Any 10-min window with no events recorded by either EarlySense’s technology or the reference technology
Clinically significant event	Any false negative or false positive event that would likely require a clinician to institute a change in clinical practice