Demographic data self-reported by parents of newborns were available from 5125 users (24.2% response rate) who participated in a survey of all active users in May 2017. OSS usage statistics were collected from all 47,495 active users. The continuous variables SpO 2 and HR were obtained from 39,626 full-term newborns. The newborns were predominantly located in the United States and Canada. Individual monitoring sessions <2 hours in duration and newborns with inconclusive or missing age were excluded from the current analysis. The study population described includes 47,495 newborns (“active users”) between the commercial launch of the device in October 2015 and May 2017, when additional demographic surveys were conducted.Īctive users were defined as those who activated the OSS for their newborns between 1 and 12 months of age, with total monitoring time ≥24 hours. Owlet Baby Care, Inc., to the best of our knowledge, has amassed the largest data set on home use of the OSS vital signs monitor in newborns up to 12 months of age. Importantly, we point out the utility of the OSS in regard to the future opportunities that it may offer to improve access to outpatient and at-home physiological monitoring of infants with specific medical conditions. With known limitations of current reports (descriptive statistics vs randomized clinical study, parent-reported prematurity, events retrospectively verified by physicians), the unique home use patterns, normative physiological reference ranges for oxygen saturation (SpO 2) and heart rate (HR) for various newborn age groups, and a case study on apnea of prematurity (AOP) detection while using the OSS are presented in this article. The objective of this report is to describe the initial experience with home use of the Owlet Smart Sock (OSS), a novel, miniaturized, wireless, vital signs monitoring device in 47,495 newborns between October 2015 and June 2017 and to share insights into the largest reported series.
3, 4 Currently, limited comprehensive, contemporary data exist to support or reject the usefulness of home-based continuous monitoring in infants. 2 Critics expressed concerns about frequent false alarms, high cost of monitors, increase in parental anxiety, and the risk of overdiagnosis. Proponents suggest that this type of monitoring can provide parents and physicians valuable information about infant health, potentially alerting when an infant is in crisis and enabling timely intervention.
However, the utility of home-based continuous monitoring, especially in healthy, term newborns, remains a controversial topic in the clinical community.
It also represents an opportunity for physicians and scientists to identify or predict various pathological conditions and provide insights into the behavioral and physical development of a child.
1 Continuous monitoring and transmission of physiological parameters in infants are not limited to alerting for and prevention of life-threatening events. Development in biomedical and computer sciences, wireless communication techniques, and low-energy consumption microprocessors with sophisticated algorithms led to the recent widespread innovation of wearable monitoring systems.
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