Analysis of clinical cross-control trial results of an smartphone application in screening neonatal jaundice / 中华实用儿科临床杂志

ABSTRACT

Objective:To evaluate the correlation, consistency and safety of an smartphone application (APP) in screening neonatal jaundice using the smartphone based on the image-based bilirubin (IBB) and transcutaneous bilirubin (TcB).Methods:From July to October 2018, neonates with the age ≤28 d and gestational age ≥35 weeks who were admitted to Department of Neonatal and Obstetrics, Xuzhou Central Hospital without blue light phototherapy were recruited.They were randomly divided into two groups to measure the jaundice value of skin in front of sternum by a cross-control analysis.Jaundice level in group Ⅰ was first measured using the Nezhabaobei? APP in iPhone 6, and then measured using the JM-103 transcutaneous jaundice instrument as the control device.In group Ⅱ, jaundice level was sequencially measured by the control device and the Nezhabaobei? APP.Sex, age, gestational age, birth weight and the mean value of three consecutive tests were recorded.The Pearson′s correlation analysis, Bland-Altman plots consistency analysis, t test and receiver operating characteristic (ROC) curve were used for statistical analysis. Results:A total of 185 eligible neonates were enrolled, including 99 males and 86 females, with the median age of 5 d (3-8 d), gestational age of (37.6 ± 1.7) weeks, and birth weight of (2 950 ± 645) g. There were good correlation ( r=0.860, P<0.05) and consistency (95.1% of the samples fall within the 95% consistency interval) between IBB and TcB.Good correlation and consistency were also yielded in subgroup analyses based on the sex, age, gestational age and birth weight.The consistency was better in subgroups of ≤7 d, >37 weeks and>2 500 g. The ability of IBB to predict TcB>256.5 μmol/L was better than that of TcB>171.0 μmol/L.The area under the ROC curve was 0.93, the cut-off value was 232.6 μmol/L, the sensitivity was 96.7%, and the specificity was 82.6%.The difference of the mean values of IBB and TcB detected for 3 times was significantly lower than that obtained in the first measurement of IBB and TcB [(12.0 ± 34.4) μmol/L vs.(14.4 ± 38.6) μmol/L, P=0.038]. There were no adverse events and no defects in the device itself. Conclusions:There are good correlation and consistency between IBB and TcB.The ability of IBB to predict TcB>256.5 μmol/L is better than that of TcB>171.0 μmol/L, which is safe in clinical use.