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

Abstract 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 hy...

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Autores principales: Animesh Halder, Aniruddha Adhikari, Ria Ghosh, Soumendra Singh, Amrita Banerjee, Nilanjana Ghosh, Arnab Madhab Bhattacharya, Shrabani Mandal, Prantar Chakrabarti, Debasis Bhattacharyya, Hatem M. Altass, Moataz Morad, Saleh A. Ahmed, Asim Kumar Mallick, Samir Kumar Pal
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Publicado: Nature Portfolio 2020
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spelling oai:doaj.org-article:bf89adfa73f54e93b93f1217354cbeb52021-12-02T15:39:58ZLarge scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors10.1038/s41598-020-67981-92045-2322https://doaj.org/article/bf89adfa73f54e93b93f1217354cbeb52020-07-01T00:00:00Zhttps://doi.org/10.1038/s41598-020-67981-9https://doaj.org/toc/2045-2322Abstract 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.Animesh HalderAniruddha AdhikariRia GhoshSoumendra SinghAmrita BanerjeeNilanjana GhoshArnab Madhab BhattacharyaShrabani MandalPrantar ChakrabartiDebasis BhattacharyyaHatem M. AltassMoataz MoradSaleh A. AhmedAsim Kumar MallickSamir Kumar PalNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 10, Iss 1, Pp 1-14 (2020)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Animesh Halder
Aniruddha Adhikari
Ria Ghosh
Soumendra Singh
Amrita Banerjee
Nilanjana Ghosh
Arnab Madhab Bhattacharya
Shrabani Mandal
Prantar Chakrabarti
Debasis Bhattacharyya
Hatem M. Altass
Moataz Morad
Saleh A. Ahmed
Asim Kumar Mallick
Samir Kumar Pal
Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors
description Abstract 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.
format article
author Animesh Halder
Aniruddha Adhikari
Ria Ghosh
Soumendra Singh
Amrita Banerjee
Nilanjana Ghosh
Arnab Madhab Bhattacharya
Shrabani Mandal
Prantar Chakrabarti
Debasis Bhattacharyya
Hatem M. Altass
Moataz Morad
Saleh A. Ahmed
Asim Kumar Mallick
Samir Kumar Pal
author_facet Animesh Halder
Aniruddha Adhikari
Ria Ghosh
Soumendra Singh
Amrita Banerjee
Nilanjana Ghosh
Arnab Madhab Bhattacharya
Shrabani Mandal
Prantar Chakrabarti
Debasis Bhattacharyya
Hatem M. Altass
Moataz Morad
Saleh A. Ahmed
Asim Kumar Mallick
Samir Kumar Pal
author_sort Animesh Halder
title Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors
title_short Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors
title_full Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors
title_fullStr Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors
title_full_unstemmed Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors
title_sort large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors
publisher Nature Portfolio
publishDate 2020
url https://doaj.org/article/bf89adfa73f54e93b93f1217354cbeb5
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