Table 1 Study eligibility criteria, endpoints, and definitions.
Eligibility criteria | |
Inclusion | Neonate with corrected age of < 28 days requiring admission to the neonatal ward, the post-natal ward, or the neonatal 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 ANNE compared to the reference technologies Diagnostic performance of ANNE compared to the reference technologies for clinical event detection including sensitivity, specificity, positive predictive value, negative predictive value, and ratio of false negative-to-false positive events Agreement between ANNE and the reference technologies for heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and temperature | |
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 temporary removal and after reconnection to ANNE and the reference technologies were also excluded |
Up-time | Measured in minutes as the total time the sensor was attached that met the a priori-identified signal quality limits for each technology |
Signal quality | HR and SpO2 ANNE—for every second, we evaluated the preceding 59 s in addition to the current second to ensure that all 60 (100%) seconds > 0 Rad-97—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 ANNE—for every second, we evaluated the preceding 59 s in addition to the current second to ensure that all 60 (100%) seconds > 0 Rad-97—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, and a capnography quality score ≥ 2 Temperature ANNE—all temperatures > 0 Spengler’s technology—all temperature spot checks |
Event second | Any second that contains a high or low HR or RR event (a value above or below the thresholds) for either ANNE or Rad-97 |
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 | A reference technology event window containing at least 1 event second identified by ANNE |
False negative event | A reference technology event window containing no event seconds recorded by ANNE |
False positive event | An event recorded by ANNE outside all reference technology’s event windows |
True negative event | Any 10-min window with no events recorded by either ANNE 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 |
