Table 1.
Eligibility criteria and study definitions.
Table 2.
Results from Bland-Altman analysis for Sibel ANNE investigational technology versus reference technology.
Fig 1.
Bland-Altman plots for heart rate (HR).
(A) Open-label round. (B) Closed-label round one. (C) Closed-label round two. (D) Closed-label round three. Colors indicate which enrolled neonate is associated with the measurement pair.
Fig 2.
Clarke error grids for closed-label round three.
(A) Comparison of heart rate (HR) measurements. (B) Comparison of Sibel ANNE respiratory rate (RR) to Masimo Rad-97 RR manual count. Each dot represents a data pair, with the color intensity proportional to density of data pairs. Region A (in green) contains data pairs that are within 20% of the Masimo Rad-97 device value. Region B (in yellow) contains data pairs not within 20% that would not lead to unnecessary treatment. Regions C, D and E are in red. C includes data pairs leading to unnecessary treatment. D includes data pairs with a failure in detecting low or high HR/RR events and E includes data pairs where low and high HR/RR events are confused.
Fig 3.
Bland-Altman plots for Rad-97 respiratory rate (RR) median.
(A) Open-label round. (B) Closed-label round one. (C) Closed-label round two. (D) Closed-label round three. Colors indicate which enrolled neonate is associated with the measurement pair.
Fig 4.
Bland-Altman plots for oxygen saturation (SpO2).
(A) Open-label round. (B) Closed-label round one.(C) Closed-label round two. (D) Closed-label round three. Colors indicate which enrolled neonate is associated with the measurement pair.
Fig 5.
Bland-Altman plots for skin surface temperature.
(A) Open-label round. (B) Closed-label round one. (C) Closed-label round two. (D) Closed-label round three. Colors indicate which enrolled neonate is associated with the measurement pair.