Heart-rate agreement between ECG and a new, wireless device during early skin-to-skin contact

Abstract

Aim: To assess the agreement of heart rate (HR) between the new device - a fabric jacket for neonates, with integrated sensors detecting ECG signals and a Bluetooth connection to a computer (ComfTech, HOWDY) - and the clinical reference, ECG, during the skin-to-skin contact (SSC) in the first 2 h after birth, for the potential use of early detection of Sudden and Unexpected Postnatal Collapse (SUPC).

Methods: We enrolled newborns ≥35⁺⁰ weeks of gestation, with Apgar score >8 at 5 min in a prospective, observational study in the delivery room, excluding infants with need for resuscitation, clinical instability or major malformations. We assessed HR within 20 min after birth by both devices simultaneously: the index test ComfTech HOWDY and the standard ECG (Vita Guard VG 3100, Getemed). We compared HR between the two methods at 0, 15, 30, 45, 60, 90 and 120 min by the Bland-Altman plot.

Results: We included 60 infants. The mean difference between the methods was -1.3 bpm, 95%LoA -12.4 to 9.7 bpm. Spearman rank correlation coefficient ρ = -0.06.

Conclusion: ComfTech HOWDY presents reliable agreement with the ECG and might assist in identifying infants at risk for SUPC.

Keywords: Bland-Altman; electrocardiogram; healthy newborn; skin-to-skin contact; sudden unexpected postnatal collapse.