595 - Validation of a novel, low-cost continuous newborn respiratory rate monitor.

Poster Number: 595
Publication Number: 595.1602

Background: Preterm birth is the single leading cause of death in children under age 5 years. Respiratory distress syndrome, a common condition in premature newborns, is a major cause of death. Apnea of prematurity affects over 50% of preterm newborns and contributes to mortality and morbidity. Abnormal respiratory rate (RR) may be a presenting symptom of underlying conditions in newborns such as pneumonia, sepsis, hypoglycemia, anemia, or seizures. When patient monitors are unavailable, the World Health Organization recommends counting breaths for 60 seconds to measure neonatal RR. In low-resource settings, patient monitors are often prohibitively expensive, and manual counting is impractical due to high nurse-to-patient ratios.

Objective: To address this need we have developed “BreathAlert”, a low-cost RR monitor that identifies breaths by measuring the displacement of an optical sensor placed around the baby’s abdomen. Through this collaborative pilot study, we aim to validate the device against reference visual counting and compare performance to existing patient monitors.

Design/Methods: We enrolled preterm newborns at Texas Children’s Hospital (TCH) in Houston, Texas, USA for respiratory monitoring. Participants received continuous monitoring with BreathAlert and standard of care monitoring from a patient monitor (GE Dash 4000). Webcam video monitoring (C925-E, Logitech) was used for manually counting breaths. Paired t-test and cross-correlation analysis was conducted between the RR from BreathAlert and impedance pneumography. Rice University IRB and Baylor College of Medicine IRB approved this study.

Results: Nine newborns at TCH averaging 31.6 weeks [30.3-36.1] gestational age and enrollment weight of 1380g [1240-1610g] were monitored for an average of 17.5 hours. BreathAlert and the reference manual counting show a very strong correlation (R = 0.97 ). RR bias and LOA were within the UNICEF/NEST 360 target product profile specifications for device validation. No adverse events have occurred.

Conclusion(s): BreathAlert shows a high degree of accuracy in detecting breaths as compared to the gold standard methods in low resource countries (manual counting). This may offer a low-cost way to improve neonatal respiratory monitoring in low-resource countries, thereby potentially decreasing both the burden on nurses and the morbidity and mortality in sick and preterm newborns.