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Research Letter
August 21, 2018

Accuracy of Pulse Oximetry-Based Home Baby Monitors

Author Affiliations
  • 1Division of General Pediatrics, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
  • 2Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia
  • 3Department of Biomedical and Health Informatics, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
  • 4Health Devices Group, ECRI Institute, Plymouth Meeting, Pennsylvania
  • 5Division of Neonatology, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
JAMA. 2018;320(7):717-719. doi:10.1001/jama.2018.9018

Smartphone-integrated consumer baby monitors that measure vital signs are popular among parents but are not regulated by the US Food and Drug Administration (FDA).1-4 This study measured the accuracy of pulse oximetry–based consumer baby monitors using an FDA-cleared oximeter as a reference.

We purchased the only 2 currently marketed smartphone-integrated consumer baby monitors that use pulse oximetry, the Owlet Smart Sock 2 (consumer monitor A) and Baby Vida (consumer monitor B). We enrolled infants aged 0 to 6 months hospitalized in general pediatrics and cardiology wards at the Children’s Hospital of Philadelphia from July through December 2017. Infants were excluded if born before 34 weeks’ gestation, critically ill, anemic (hemoglobin <10 g/dL), febrile (≥38.0°C), hypothermic (<36.0°C), hypotensive (systolic blood pressure <60 mm Hg if 0-28 days old or <70 mm Hg if 29 days–6 months old), or had compromised perfusion. Written informed consent was obtained from infants’ parents. The Children’s Hospital of Philadelphia’s institutional review board approved the study.