Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors

• Published in: Scientific reports Vol. 10; no. 1; p. 11149
• Main Authors: Halder, Animesh, Adhikari, Aniruddha, Ghosh, Ria, Singh, Soumendra, Banerjee, Amrita, Ghosh, Nilanjana, Bhattacharya, Arnab Madhab, Mandal, Shrabani, Chakrabarti, Prantar, Bhattacharyya, Debasis, Altass, Hatem M., Morad, Moataz, Ahmed, Saleh A., Mallick, Asim Kumar, Pal, Samir Kumar
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 07.07.2020; Nature Publishing Group; Nature Portfolio
• Subjects: 639/166/985; 692/499; 692/700/1720; 692/700/1720/3187; Bilirubin; Bilirubin - blood; Birth Weight; Feeding behavior; Female; Gestational Age; Humanities and Social Sciences; Humans; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal - blood; Hyperbilirubinemia, Neonatal - diagnosis; Infant, Newborn; Light therapy; Male; multidisciplinary; Neonates; Phototherapy; Prospective Studies; Reproducibility of Results; Risk Factors; ROC Curve; Science; Science (multidisciplinary); Sensitivity and Specificity
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-020-67981-9

The study was aimed to evaluate the performance of a newly developed non-invasive and non-contact bilirubin measurement device (AJO-Neo) as an alternative to the conventional invasive biochemical method of total serum bilirubin (TSB) estimation in preterm and term neonates suffering from hyperbilirubinemia associated with risk factors, and/or undergoing phototherapy. The safety and efficacy of the device were assessed in 1968 neonates with gestational ages ranging from 28 to 41 weeks and suffering from incidences of hyperbilirubinemia. Linear regression analysis showed a good correlation between AJO-Neo and the conventional method of TSB (Pearson’s coefficient, r  = 0.79). The small bias (0.27 mg/dL) and limits of agreements (− 3.44 to 3.99 mg/dL) were within the range of clinical acceptance. The device was also precise in the measurement of bilirubin levels in all subgroups of the study. The receiver operator curve (ROC), that takes account of both sensitivity and specificity of a device showed high efficacy of the device (area under the curve, AUC = 0.83) in the detection of bilirubin. While monitoring the bilirubin level during phototherapy, the device indicated promising results showing good agreement with TSB. Specificities and sensitivities of the device indicated a much higher accuracy in neonates with associated risk factors for hyperbilirubinemia. Hence, the newly developed device (AJO-Neo) is reliable in measuring bilirubin level in preterm, and term neonates irrespective of gestational or postnatal age, sex, risk factors, feeding behavior or skin color.