Clinical utility of hand held, non invasive transcutaneous bilirubinometer in neonatal jaundice: a prospective observational study

Background: Neonatal Jaundice is the most common morbidity in the first week of life, occurring in 60% of term and 80% of preterm newborn. However, visual inspection, being subjective, usually inaccurate and unreliable and will result in a number of unnecessary blood sampling. Taking all these in to considerations, transcutaneous bilirubinometer (TCB) may provide a solution which is an objective, noninvasive, fast and painless method of bilirubin estimation.Methods: Transcutaneous bilirubinometer levels were measured at forehead and sternum and blood samples for TSB were collected by venepuncture within 30 minutes and sent to biochemistry lab. After getting serum bilirubin reports, TCB and TSB values were compared by using Bhutani’s hour specific nomogram. Results: The correlation between serum bilirubin and transcutaneous bilirubin measured at forehead and sternum is very good at serum bilirubin <15 mg/dl, r value (Karl Pearson’s Correlation co-efficient) is 0.93 and 0.94 respectively.Conclusions: The findings of the present study indicate that the TCB is a reliable screening tool for hyperbilirubinemia in newborns >35 weeks of gestation, especially with bilirubin levels ≤15 mg/dl in 2-7 days of life. TCB can be a viable option for universal screening. Incorporating the use of TCB devices in clinical practice, can reduce the need for blood sampling for the management of neonatal jaundice.

The Impact of Phototherapy on the Accuracy of Transcutaneous Bilirubin Measurements in Neonates: Optimal Measurement Site and Timing

Transcutaneous bilirubinometer devices are widely applied to assess neonatal hyperbilirubinemia. However, the optimal skin site and timing of transcutaneous bilirubin (TCB) measurements for the strongest correlation with total serum bilirubin (TSB) levels after phototherapy are still unclear. We conducted a retrospective observational study evaluating the correlation of TCB and TSB levels in neonates postphototherapy. The TCB measurements on the forehead and mid-sternum at 0 and 30 min postphototherapy were assessed by using a JM-103 bilirubinometer. Paired TCB and TSB measurements were assessed by Pearson correlation and Bland–Altman plots. We analyzed 40 neonates with 96 TSB and 384 TCB measurements. The TSB level correlated moderately with the forehead TCB level at 30 min postphototherapy (r = 0.65) and less strongly with the midsternum TCB level at 0 min postphototherapy (r = 0.52). The forehead at 30 min after cessation of phototherapy was the best time point and location of TCB measurement for the assessment of neonatal jaundice status. The reliability of TCB measurements varied across skin sites and durations after phototherapy. The effectiveness of TCB measurement to assess neonatal hyperbilirubinemia is much better on covered skin areas (foreheads) 30 min postphototherapy. The appropriate application of transcutaneous bilirubinometers could aid in clinical practice and avoid unnecessary management.

Correlation of serum bilirubin and transcutaneous bilirubin in newborns

Background: Hyperbilirubinemia is a very common entity in newborns. Screening all the babies for hyperbilirubinemia is must. Serum bilirubin is the standard method of checking the bilirubin in newborns. This is very cumbersome, invasive and time consuming method. Hence many newborns will be discharged without screening. Transcutaneous bilirubinometry would help us in making this task easy and safe. Hence the present study was planned.Methods: This is an institutional cross sectional study conducted in a tertiary care hospital for a period of 6 months. After a written informed consent from parents/ guardians and considering selection criteria, 500 newborns with clinical jaundice were included in study. Each newborn was examined, transcutaneous bilirubin checked at forehead and sternum and serum bilirubin was done at the same time. Data was statistically analyzed to see the correlation between TcB and TSB.Results: Out of 500 newborns, 316 were males, 184 were females and 475 were term gestation and 25 were preterm. Coefficient of correlation was 0.73 and 0.72 for total serum bilirubin versus forehead and sternum respectively which were statistically significant.Conclusions: Transcutaneous bilirubinometer readings closely correlate with that of serum bilirubin. Hence TcB can be used as a safer, economical and effective tool in screening newborns for hyperbilirubinemia.

Neonatal wearable device for colorimetry-based real-time detection of jaundice with simultaneous sensing of vitals

Neonatal jaundice occurs in >80% of newborns in the first week of life owing to physiological hyperbilirubinemia. Severe hyperbilirubinemia could cause brain damage owing to its neurotoxicity, a state commonly known as kernicterus. Therefore, periodic bilirubin monitoring is essential to identify infants at-risk and to initiate treatment including phototherapy. However, devices for continuous measurements of bilirubin have not been developed yet. Here, we established a wearable transcutaneous bilirubinometer that also has oxygen saturation (SpO2) and heart rate (HR) sensing functionalities. Clinical experiments with neonates demonstrated the possibility of simultaneous detection of bilirubin, SpO2, and HR. Moreover, our device could consistently measure bilirubin during phototherapy. These results demonstrate the potential for development of a combined treatment approach with an automatic link via the wearable bilirubinometer and phototherapy device for optimization of the treatment of neonatal jaundice.

Diagnostic Properties of a Portable Point-of-Care Method to Measure Bilirubin and a Transcutaneous Bilirubinometer

<b><i>Background:</i></b> Recently, the Bilistick®, a point-of-care instrument to measure bilirubin levels, has been developed. It is fast and cheaper than transcutaneous bilirubin (TCB)-measuring devices, but data on diagnostic properties are scarce. <b><i>Objective:</i></b> This study aimed to compare the performance of the Bilistick® (BM-BS 1.0 – FW version 2.0.1) and the JM-105 bilirubinometer for measuring bilirubin. <b><i>Method:</i></b> This is a prospective study in infants born after ≥32 weeks’ gestation, and/or a birth weight of ≥1,500 g, and a postnatal age ≤14 days in Surabaya, Indonesia. Bilirubin was measured with the Bilistick® System (BM-BS 1.0 – FW version 2.0.1), transcutaneously (TCB) with the JM-105 bilirubinometer, and in serum (TSB) with a routine laboratory technique. Mean differences and 95% limits of agreement (LOA) and correlations were calculated. <b><i>Result:</i></b> We enrolled 149 neonates and 126 had paired measurements of Bilistick® bilirubin, TCB, and TSB. Bilistick® failed in 16 (10.7%) infants. Mean Bilistick® bilirubin-TSB difference was −11 µmol/L (95% LOA: −101 to 79 µmol/L) and <i>r</i> = 0.738 (<i>p</i> &#x3c; 0.001). Mean TCB-TSB difference was 26 μmol/L (95% LOA: −33 to 88) and <i>r</i> = 0.785 (<i>p</i> &#x3c; 0.001). The sensitivity, specificity, PPV, and NPV for Bilistick® bilirubin for a TSB above treatment thresholds were 0.74, 0.84, 0.67, and 0.88, respectively, and for TCB 0.92, 0.64, 0.54, and 0.95, respectively. <b><i>Conclusion:</i></b> The Bilistick® System (BM-BS 1.0 – FW version 2.0.1) underestimates TSB, whereas TCB overestimates TSB in jaundiced Indonesian infants. Further improvement of Bilistick®’s diagnostic accuracy with less false-negative readings is essential to increase its use.

Development of Jaundice Detection Approaches in Neonates

Jaundice is one of the most common diseases that have a significant impact in the first few days of newborn life. Detection and regular monitoring of bilirubin, which is responsible for Jaundice, is an essential phase during the hyperbilirubinemia. In the literature, various clinical assessment methods of Jaundice are available. It motivates us to present a review of these clinical assessment methods in practice, along with their advantages and limitations. In this paper, we have discussed three widely used methods, such as visual assessment, total serum bilirubin and transcutaneous bilirubinometer. From the comparative analysis of these methods, it is concluded that the visual assessment is very subjective in nature, whereas, the total serum bilirubin method is still a gold standard method. The detailed analysis of the methods depicts that the correlation between this two total serum bilirubin and transcutaneous bilirubinometer has enormous potential for improvement resulting in the enhancement in precision and accuracy of bilirubin measurement.

Can we Rely on Transcutaneous Bilirbinometry during Phototherapy?

Background:Neonatal jaundiceis one of the main reasons for prolonged hospitalization in newborns, and its progress and treatment depends on serum bilirubin values. Phototherapy remains the mainstay of treatment of pathological jaundice in newborn babies. Though, transcutaneous bilirubinometer has been used as a screening device for measuring bilirubin, its role during phototherapy has always been questioned. Objective: To study the correlation between Transcutaneous bilirubinometer (TcB) values with serum bilirubin levels (TSB) in infants during phototherapy in term and late preterm babies. Materials and Methods: The study was conducted in a tertiary new-born center from November 2014 to June 2016. The inclusion criteria included all babies above 34 weeks gestation and exclusion criteria included babies with established direct hyperbilirubinemia, neonatal septicemia, major congenital/ gastrointestinal malformations, and those on phototherapy.