Comparison of a new transcutaneous bilirubinometer (Bilimed®) with serum bilirubin measurements in preterm and full-term infants

Abstract

BackgroundThe gold standard to assess hyperbilirubinemia in neonates remains the serum bilirubin measurement. Unfortunately, this is invasive, painful, and costly. Bilimed®, a new transcutaneous bilirubinometer, suggests more accuracy compared to the existing non-invasive bilirubinometers because of its new technology. It furthermore takes into account different skin colours. No contact with the skin is needed during measurement, no additional material costs occur. Our aim was to assess the agreement between the Bilimed® and serum bilirubin in preterm and term infants of different skin colours.MethodsThe transcutaneous bilirubin measurements were performed on the infant's sternum and serum bilirubin was determined simultaneously. The agreement between both methods was assessed by Pearson's correlation and by Bland-Altman analysis.ResultsA total of 117 measurement cycles were performed in 99 term infants (group1), further 47 measurements in 38 preterm infants born between 34 - 36 6/7 gestational weeks (group 2), and finally 21 measurements in 13 preterm infants born between 28 - 33 6/7 gestational weeks (group 3). The mean deviation and variability (+/- 2SD) of the transcutaneous from serum bilirubin were: -14 (+/- 144) μmol/l; -0.82 (+/- 8.4) mg/dl in group 1, +16 (+/- 91) μmol/l;+0.93(+/- 5.3) mg/dl in group 2 and -8 (+/- 76) μmol/l; -0.47 (+/- 4.4) mg/dl in group 3. These limits of agreement are too wide to be acceptable in a clinical setting. Moreover, there was to be a trend towards less good agreement with increasing bilirubin values.ConclusionDespite its new technology the Bilimed® has no advantages, and more specifically no better agreement not only in term and near-term Caucasian infants, but also in non-Caucasian and more premature infants.

Reliability of Transcutaneous Bilirubin Devices in Preterm Infants: A Systematic Review

“…The studies were published between the years 2003 and 2012, and the majority used either JM-103 (6 studies) or BiliCheck (6 studies) devices except for the study by Karen et al, 26 which used Bilimed. In addition, 2 studies…”

“…Twenty-one studies 9,[20][21][22][23][24][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] provided results for correlation coefficients, and the pooled estimates according to the site of measurement were as follows: (Fig 2). There were no subgroup differences with respect to …”

“…Thirteen studies 20,21,23,25,26,[32][33][34][35][36][37]39,40 provided results as an analysis of the Bland-Altman difference plots. The studies were published between the years 2003 and 2012, and the majority used either JM-103 (6 studies) or BiliCheck (6 studies) devices except for the study by Karen et al, 26 which used Bilimed.…”

Screening neonatal jaundice based on the sclera color of the eye using digital photography

“…Numerous studies have compared the agreement between TcB and TSB [5][6][7][8][9][10][11][12][13][14][15][16]. One review in 2013 summarised the results from 22 studies conducted between 1982 and 2012 ( [5][6][7][8][9][10][11][12][13][14][15][16]), mainly on BiliChek and JM-103 (and its earlier versions) [6].…”

“…Currently, the two most popular commercial TcBs include BiliChek (Philips Healthcare) and Jaundice Meter JM102/JM103 (Draeger Medical Inc., previously marketed by Konica Minolta Inc.) [5][6][7][8][9][10][11][12][13][14][15][16]. The skin pigment is the most influential confounding factor for the skin colour approach.…”