Dataset Information

Smartphone screening for neonatal jaundice via ambient-subtracted sclera chromaticity.

ABSTRACT: Jaundice is a major cause of mortality and morbidity in the newborn. Globally, early identification and home monitoring are significant challenges in reducing the incidence of jaundice-related neurological damage. Smartphone cameras are promising as colour-based screening tools as they are low-cost, objective and ubiquitous. We propose a novel smartphone method to screen for neonatal jaundice by imaging the sclera. It does not rely on colour calibration cards or accessories, which may facilitate its adoption at scale and in less economically developed regions. Our approach is to explicitly address three confounding factors in relating colour to jaundice: (1) skin pigmentation, (2) ambient light, and (3) camera spectral response. (1) The variation in skin pigmentation is avoided by imaging the sclera. (2) With the smartphone screen acting as an illuminating flash, a flash/ no-flash image pair is captured using the front-facing camera. The contribution of ambient light is subtracted. (3) In principle, this permits a device- and ambient-independent measure of sclera chromaticity following a one-time calibration. We introduce the concept of Scleral-Conjunctival Bilirubin (SCB), in analogy with Transcutaneous Bilirubin (TcB). The scleral chromaticity is mapped to an SCB value. A pilot study was conducted in the UCL Hospital Neonatal Care Unit (n = 37). Neonates were imaged using a specially developed app concurrently with having a blood test for total serum bilirubin (TSB). The better of two models for SCB based on ambient-subtracted sclera chromaticity achieved r = 0.75 (p<0.01) correlation with TSB. Ambient subtraction improved chromaticity estimates in proof-of-principle laboratory tests and screening performance within our study sample. Using an SCB decision threshold of 190?mol/L, the sensitivity was 100% (specificity 61%) in identifying newborns with TSB>250?mol/L (area under receiver operating characteristic curve, AUROC, 0.86), and 92% (specificity 67%) in identifying newborns with TSB>205?mol/L (AUROC 0.85). These results are comparable to modern transcutaneous bilirubinometers.

SUBMITTER: Outlaw F

PROVIDER: S-EPMC7051077 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Smartphone screening for neonatal jaundice via ambient-subtracted sclera chromaticity.

Outlaw Felix F Nixon Miranda M Odeyemi Oluwatobiloba O MacDonald Lindsay W LW Meek Judith J Leung Terence S TS

PloS one 20200302 3

Jaundice is a major cause of mortality and morbidity in the newborn. Globally, early identification and home monitoring are significant challenges in reducing the incidence of jaundice-related neurological damage. Smartphone cameras are promising as colour-based screening tools as they are low-cost, objective and ubiquitous. We propose a novel smartphone method to screen for neonatal jaundice by imaging the sclera. It does not rely on colour calibration cards or accessories, which may facilitate ...[more]

PMID: 32119664

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Project description:BackgroundMedical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable.ObjectiveThis study aimed to develop a novel system to assess the presence of NNJ. The device should provide accurate results, be approved as a medical device, be easy to use, and be produced at a price that is affordable even in low-resource settings.MethodsWe used an iterative approach to develop a smartphone-based system to detect the presence of NNJ. We performed technical development, followed by clinical and usability testing in parallel, after which we initiated the regulatory processes for certification. We updated the system in each iteration, and the final version underwent a clinical validation study on healthy term newborns aged 1 to 15 days before all documentation was submitted for conformity assessment to obtain Conformité Européenne (CE) certification. We developed a system that incorporates a smartphone app, a color calibration card, and a server.ResultsThree iterations of the smartphone-based system were developed; the final version was approved as a medical device after complying with Medical Device Regulation guidelines. A total of 201 infants were included in the validation study. Bilirubin values using the system highly correlated with total serum or plasma bilirubin levels (r=0.84). The system had a high sensitivity (94%) to detect severe jaundice, defined as total serum or plasma bilirubin >250 µmol/L, and maintained a high specificity (71%).ConclusionsOur smartphone-based system has a high potential as a tool for identifying NNJ. An iterative approach to product development, conducted by working on different tasks in parallel, resulted in a functional and successful product. By adhering to the requirements for regulatory approval from the beginning of the project, we were able to develop a market-ready mobile health solution.

Project description:BackgroundPhototherapy is a widely accepted, effective first-line therapy for neonatal jaundice. It is traditionally used continuously but intermittent phototherapy has been proposed as an equally effective alternative with practical advantages of improved maternal feeding and bonding. The effectiveness of intermittent phototherapy compared with continuous phototherapy is unknown.ObjectivesTo assess the safety and effectiveness of intermittent phototherapy compared with continuous phototherapy.Search methodsSearches were conducted on 31 January 2022 in the following databases: CENTRAL via CRS Web, MEDLINE and Embase via Ovid. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.Selection criteriaWe included RCTs, cluster-RCTs and quasi-RCTs comparing intermittent phototherapy with continuous phototherapy in jaundiced infants (both term and preterm) up to the age of 30 days. We compared intermittent phototherapy with continuous phototherapy by any method and at any dose and duration as defined by the authors.Data collection and analysisThree review authors independently selected trials, assessed trial quality and extracted data from included studies. We performed fixed-effect analyses and expressed treatment effects as mean difference (MD), risk ratio (RR) and risk difference (RD) with 95% confidence intervals (CIs). Our primary outcomes of interest were rate of decline of serum bilirubin, and kernicterus. We used the GRADE approach to assess the certainty of evidence.Main resultsWe included 12 RCTs (1600 infants) in the review. There is one ongoing study and four awaiting classification. There was little or no difference between intermittent phototherapy and continuous phototherapy with respect to rate of decline of bilirubin in jaundiced newborn infants (MD -0.09 micromol/L/hr, 95% CI -0.21 to 0.03; I² = 61%; 10 studies; 1225 infants; low-certainty evidence). One study involving 60 infants reported no incidence of bilirubin induced brain dysfunction (BIND). It is uncertain whether either intermittent or continuous phototherapy reduces BIND because the certainty of this evidence is very low. There was little or no difference in treatment failure (RD 0.03, 95% CI 0.08 to 0.15; RR 1.63, 95% CI 0.29 to 9.17; 1 study; 75 infants; very low-certainty evidence) or infant mortality (RD -0.01, 95% CI -0.03 to 0.01; RR 0.69, 95% CI 0.37 to 1.31 I² = 0%; 10 studies, 1470 infants; low-certainty evidence). AUTHORS' CONCLUSIONS: The available evidence detected little or no difference between intermittent and continuous phototherapy with respect to rate of decline of bilirubin. Continuous phototherapy appears to be more effective in preterm infants, however, the risks of continuous phototherapy and the potential benefits of a slightly lower bilirubin level are unknown. Intermittent phototherapy is associated with a decrease in the total number of hours of phototherapy exposure. There are theoretical benefits to intermittent regimens but there are important safety outcomes that were inadequately addressed. Large, well designed, prospective trials are needed in both preterm and term infants before it can be concluded that intermittent and continuous phototherapy regimens are equally effective.

Project description:BackgroundHyperbilirubinemia is emerging as an increasingly common problem in newborns due to a decreasing hospital length of stay after birth. Jaundice is the most common disease of the newborn and although being benign in most cases it can lead to severe neurological consequences if poorly evaluated. In different areas of medicine, data mining has contributed to improve the results obtained with other methodologies.Hence, the aim of this study was to improve the diagnosis of neonatal jaundice with the application of data mining techniques.MethodsThis study followed the different phases of the Cross Industry Standard Process for Data Mining model as its methodology.This observational study was performed at the Obstetrics Department of a central hospital (Centro Hospitalar Tâmega e Sousa--EPE), from February to March of 2011. A total of 227 healthy newborn infants with 35 or more weeks of gestation were enrolled in the study. Over 70 variables were collected and analyzed. Also, transcutaneous bilirubin levels were measured from birth to hospital discharge with maximum time intervals of 8 hours between measurements, using a noninvasive bilirubinometer.Different attribute subsets were used to train and test classification models using algorithms included in Weka data mining software, such as decision trees (J48) and neural networks (multilayer perceptron). The accuracy results were compared with the traditional methods for prediction of hyperbilirubinemia.ResultsThe application of different classification algorithms to the collected data allowed predicting subsequent hyperbilirubinemia with high accuracy. In particular, at 24 hours of life of newborns, the accuracy for the prediction of hyperbilirubinemia was 89%. The best results were obtained using the following algorithms: naive Bayes, multilayer perceptron and simple logistic.ConclusionsThe findings of our study sustain that, new approaches, such as data mining, may support medical decision, contributing to improve diagnosis in neonatal jaundice.

Dataset Information

Smartphone screening for neonatal jaundice via ambient-subtracted sclera chromaticity.

Publications

Smartphone screening for neonatal jaundice via ambient-subtracted sclera chromaticity.

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