Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors
Autor: | Ria Ghosh, Samir Kumar Pal, Soumendra Singh, Saleh A. Ahmed, Asim Kumar Mallick, Debasis Bhattacharyya, Aniruddha Adhikari, Prantar Chakrabarti, Shrabani Mandal, Amrita Banerjee, Animesh Halder, Nilanjana Ghosh, Moataz Morad, Arnab Madhab Bhattacharya, Hatem M. Altass |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Male
medicine.medical_specialty Bilirubin Birth weight Science Gestational Age Paediatric research Gastroenterology Sensitivity and Specificity Article 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine 030225 pediatrics Internal medicine Linear regression Medicine Birth Weight Humans 030212 general & internal medicine Prospective Studies Prospective cohort study Multidisciplinary Receiver operating characteristic business.industry Area under the curve Infant Newborn Gestational age Reproducibility of Results Paediatrics chemistry Risk factors ROC Curve Gestation Female Hyperbilirubinemia Neonatal business Biomedical engineering |
Zdroj: | Scientific Reports, Vol 10, Iss 1, Pp 1-14 (2020) Scientific Reports |
ISSN: | 2045-2322 |
Popis: | 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. |
Databáze: | OpenAIRE |
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