Validation of a Mobile Health Device for Neonatal Jaundice Screening: A Cross-Sectional Study in a Resource-Limited Setting in Mexico

验证一款用于新生儿黄疸筛查的移动健康设备:墨西哥资源匮乏地区横断面研究

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Abstract

OBJECTIVE: To evaluate the performance of Picterus Jaundice Pro (Picterus JP), a mobile health device for neonatal jaundice (NNJ) screening, in Mexican newborns. METHODOLOGY: A cross-sectional study was conducted from January 2023 to June 2024 at a hospital in a resource-limited setting in Mexico. The main outcomes were Picterus JP measurements and total serum bilirubin (TSB) levels. RESULTS: A total of 177 term newborns, aged 1 to 14 days, were enrolled. Picterus JP showed a significant positive Spearman's rho correlation with TSB (ρ = .68), sensitivity of 85.7% and specificity of 80.1% to detect TSB ≥ 250 using Picterus cut off value of 202 µmol/L. However, it tended to underestimate higher bilirubin levels. CONCLUSION: Picterus JP shows potential to be a useful tool for NNJ screening, particularly in resource-limited areas. Further validation across more diverse populations and clinical environments, alongside accuracy improvements, is necessary to enhance its utility and support wider implementation.Registered in ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT06276582).

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