Imperial College London



Title: Validation of transcutaneous bilirubinometry during phototherapy for detection and monitoring of neonatal jaundice in a low-income setting.Johnson SM*a, Vasu V*b, Marseille Cc, Hill Cc, Janvier Lc, Toussaint Pc, Battersby Cd*Joint first authors a Paediatrics department, Queen Elizabeth Hospital, Woolwich, United Kingdomb Neonatal Unit, East Kent Hospitals University NHS Foundation Trust, Ashford, Kent, United Kingdom c Neonatal Unit, Hospital Convention Baptiste d’Haiti (HCBH) , Cap Ha?tien, Haiti d Section of Neonatal Medicine, Imperial College London, United Kingdom Corresponding author: c.battersby@imperial.ac.ukAddress: Unit Key words: Jaundice, Transcutaneous bilirubinometry, phototherapy, low-income countries, Haiti, neonates, newborn, infantsWord count: 1870 Abstract (301 words)Background Severe neonatal jaundice (SNJ) and associated long term health sequelae are a significant problem in low income countries (LIC) where measurement of total serum bilirubin (TSB) is often unavailable. Transcutaneous bilirubinometry (TcB) provides opportunity for non-invasive, point-of-care monitoring. Few studies have evaluated its agreement with TSB levels during phototherapy in LICs.AimTo determine agreement between TcB and TSB during phototherapy in a Haiti newborn population, and to establish if TcB can be safely used to guide treatment during phototherapy when TSB is unavailable. MethodsA single centre prospective study (February-May 2017) in Cap Ha?tien, northern Haiti was conducted. Newborns with clinically detected jaundice, <7 days of age were eligible for inclusion. A TcB device (JM-103) was used to screen for newborn jaundice along with a parallel TSB. A strip of black tape was placed across the sternum during phototherapy and uncovered for subsequent TcB measurements. Phototherapy treatment decisions were based upon UK National Institute of Clinical Excellence (NICE) threshold criteria. Paired TSB and TcB measurements were compared using Bland Altman methods. Results The final analysis included 70 parallel TSB/TcB measurements from 35 infants within the first five days of life. 19 (54.3%) were male; 12 (34.3%) were <35 weeks. 32 (91.4%) were receiving phototherapy. There was good agreement between TSB and TcB. TcB tended to overestimate bilirubin in comparison to TSB; mean difference 11.1 ?mol/L (95% CI -10.2, 32.5 ?mol/L). However, at higher bilirubin levels (>250 ?mol/L), TcB tended to underestimate bilirubin in comparison to TSB and the magnitude of the difference increased. ConclusionIn a LIC setting where serum bilirubin testing is not commonly available, TcB demonstrates good agreement with TSB and can be safely used to guide jaundice treatment during phototherapy but may lead to overtreatment at lower bilirubin levels and are more inaccurate at higher levels. For TcB levels >250?mol, confirmation with serum bilirubin should be performed if available to avoid underestimation.IntroductionNeonatal jaundice is a common finding worldwide and usually physiological and transient in nature. However, severe neonatal jaundice (SNJ), particularly if not detected treated promptly, can result in serious long term adverse health outcomes including sensorineural hearing loss, kernicterus and choreoathetoid cerebral palsy ADDIN EN.CITE <EndNote><Cite><Author>Mwaniki</Author><Year>2012</Year><RecNum>3084</RecNum><DisplayText>[1]</DisplayText><record><rec-number>3084</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530530345">3084</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mwaniki, Michael K.</author><author>Atieno, Maurine</author><author>Lawn, Joy E.</author><author>Newton, Charles R. J. C.</author></authors></contributors><titles><title>Long-term neurodevelopmental outcomes after intrauterine and neonatal insults: a systematic review</title><secondary-title>Lancet</secondary-title></titles><periodical><full-title>Lancet</full-title></periodical><pages>445-452</pages><volume>379</volume><number>9814</number><dates><year>2012</year></dates><publisher>Lancet Publishing Group</publisher><isbn>0140-6736&#xD;1474-547X</isbn><accession-num>PMC3273721</accession-num><urls><related-urls><url>(11)61577-8</electronic-resource-num><remote-database-name>Pmc</remote-database-name></record></Cite></EndNote>[1]. The burden of severe neonatal jaundice (SNJ) is disproportionately high in low-middle income countries (LMIC) in comparison to high income countries (HIC) (incidence per 10,000 live births: LMIC 244.1 v HIC 3.7) ADDIN EN.CITE <EndNote><Cite><Author>Slusher</Author><Year>2017</Year><RecNum>3085</RecNum><DisplayText>[2]</DisplayText><record><rec-number>3085</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530530854">3085</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Slusher, Tina M.</author><author>Zamora, Tara G.</author><author>Appiah, Duke</author><author>Stanke, Judith U.</author><author>Strand, Mark A.</author><author>Lee, Burton W.</author><author>Richardson, Shane B.</author><author>Keating, Elizabeth M.</author><author>Siddappa, Ashajoythi M.</author><author>Olusanya, Bolajoko O.</author></authors></contributors><titles><title>Burden of severe neonatal jaundice: a systematic review and meta-analysis</title><secondary-title>BMJ Paediatrics Open</secondary-title></titles><periodical><full-title>BMJ Paediatrics Open</full-title></periodical><pages>e000105</pages><volume>1</volume><number>1</number><dates><year>2017</year></dates><publisher>BMJ Publishing Group</publisher><isbn>2399-9772</isbn><accession-num>PMC5862199</accession-num><urls><related-urls><url>;[2]. A contributing factor is the unaffordability and lack of laboratory facilities for timely total serum bilirubin (TSB) testing, and in these low settings, transcutaneous bilirubinometry (TcB) offers a non-invasive, point-of-care alternative. However, accuracy of TcB at higher levels, in preterm infants, and during phototherapy is uncertain, and therefore in well-resourced countries which use TcB to screen for jaundice, TcB is only recommended in infants above 35 weeks gestation and without phototherapy and readings above 250?micromol/litre should be confirmed with a TSB ADDIN EN.CITE <EndNote><Cite><Author>National Institute for Health and Care Excellence</Author><Year>2016</Year><RecNum>3089</RecNum><DisplayText>[3, 4]</DisplayText><record><rec-number>3089</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530534759">3089</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>National Institute for Health and Care Excellence,</author></authors></contributors><titles><title>Jaundice in newborn babies under 28 days. CG98</title></titles><dates><year>2016</year></dates><urls><related-urls><url> November 2017</access-date></record></Cite><Cite><Author>Rennie</Author><Year>2010</Year><RecNum>3211</RecNum><record><rec-number>3211</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1548929804">3211</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rennie, Janet</author><author>Burman-Roy, Shona</author><author>Murphy, M Stephen</author></authors></contributors><titles><title>Neonatal jaundice: summary of NICE guidance</title><secondary-title>BMJ</secondary-title></titles><periodical><full-title>BMJ</full-title></periodical><pages>c2409</pages><volume>340</volume><dates><year>2010</year></dates><urls></urls><electronic-resource-num>10.1136/bmj.c2409</electronic-resource-num></record></Cite></EndNote>[3, 4]. There is a paucity of studies from low income countries evaluating TcB accuracy during phototherapy. Only one study included in a systematic review evaluating the effect of phototherapy TcB, was conducted in a low-income country. The review found moderate correlation between TcB and TSB, but lower agreement during phototherapy and better correlation at sites shielded from phototherapy ADDIN EN.CITE <EndNote><Cite><Author>Nagar</Author><Year>2016</Year><RecNum>3090</RecNum><DisplayText>[5]</DisplayText><record><rec-number>3090</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530534883">3090</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nagar, G.</author><author>Vandermeer, B.</author><author>Campbell, S.</author><author>Kumar, M.</author></authors></contributors><titles><title>Effect of Phototherapy on the Reliability of Transcutaneous Bilirubin Devices in Term and Near-Term Infants: A Systematic Review and Meta-Analysis</title><secondary-title>Neonatology</secondary-title></titles><periodical><full-title>Neonatology</full-title></periodical><pages>203-12</pages><volume>109</volume><number>3</number><dates><year>2016</year></dates><isbn>1661-7819 (Electronic)&#xD;1661-7800 (Linking)</isbn><urls></urls></record></Cite></EndNote>[5]. A study in Malawi was the first to assess whether TcB can be used to guide phototherapy treatment in a resource-poor setting ADDIN EN.CITE <EndNote><Cite><Author>Rylance</Author><Year>2014</Year><RecNum>3075</RecNum><DisplayText>[6]</DisplayText><record><rec-number>3075</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1523782363">3075</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rylance, S.</author><author>Yan, J.</author><author>Molyneux, E.</author></authors></contributors><titles><title>Can transcutaneous bilirubinometry safely guide phototherapy treatment of neonatal jaundice in Malawi?</title><secondary-title>Paediatr Int Child Health</secondary-title></titles><periodical><full-title>Paediatr Int Child Health</full-title></periodical><pages>101-7</pages><volume>34</volume><number>2</number><dates><year>2014</year></dates><isbn>2046-9055 (Electronic)&#xD;2046-9047 (Linking)</isbn><urls></urls></record></Cite></EndNote>[6]. This study of 129 infants concluded that TcB can be safely used during phototherapy in the absence of TSB, but recommended validation of TcB agreement in specific settings, population, and devices ADDIN EN.CITE <EndNote><Cite><Author>Nagar</Author><Year>2013</Year><RecNum>3091</RecNum><DisplayText>[7]</DisplayText><record><rec-number>3091</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530534883">3091</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nagar, G.</author><author>Vandermeer, B.</author><author>Campbell, S.</author><author>Kumar, M.</author></authors></contributors><titles><title>Reliability of transcutaneous bilirubin devices in preterm infants: a systematic review</title><secondary-title>Pediatrics</secondary-title></titles><periodical><full-title>Pediatrics</full-title></periodical><pages>871-81</pages><volume>132</volume><number>5</number><dates><year>2013</year></dates><isbn>1098-4275 (Electronic)&#xD;0031-4005 (Linking)</isbn><urls></urls></record></Cite></EndNote>[7]. Phototherapy can theoretically affect the TcB as it reflects the yellowish discolouration of blanched skin ADDIN EN.CITE <EndNote><Cite><Author>Tan</Author><Year>2003</Year><RecNum>3076</RecNum><DisplayText>[8, 9]</DisplayText><record><rec-number>3076</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1523801575">3076</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Tan, K. L.</author><author>Dong, F.</author></authors></contributors><titles><title>Transcutaneous bilirubinometry during and after phototherapy</title><secondary-title>Acta Paediatr</secondary-title></titles><periodical><full-title>Acta Paediatr</full-title></periodical><pages>327-31</pages><volume>92</volume><number>3</number><dates><year>2003</year></dates><isbn>0803-5253 (Print)&#xD;0803-5253 (Linking)</isbn><urls></urls></record></Cite><Cite><Author>Olusanya</Author><Year>2017</Year><RecNum>3105</RecNum><record><rec-number>3105</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530535968">3105</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Olusanya, B. O.</author><author>Emokpae, A. A.</author></authors></contributors><titles><title>Use of Transcutaneous Bilirubin to Determine the Need for Phototherapy in Resource-Limited Settings</title><secondary-title>Neonatology</secondary-title></titles><periodical><full-title>Neonatology</full-title></periodical><pages>324-330</pages><volume>111</volume><number>4</number><dates><year>2017</year></dates><isbn>1661-7819 (Electronic)&#xD;1661-7800 (Linking)</isbn><urls></urls></record></Cite></EndNote>[8, 9]. Therefore TcB manufacturers recommend covering an area of skin during phototherapy that can be used for measurements ADDIN EN.CITE <EndNote><Cite><Author>Philips</Author><Year>2017</Year><RecNum>3216</RecNum><DisplayText>[10]</DisplayText><record><rec-number>3216</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1549026864">3216</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Philips,</author></authors></contributors><titles><title>BiliChek noninvasive bilirubin assessment tool</title></titles><volume>2018</volume><number>June 19th </number><dates><year>2017</year></dates><urls><related-urls><url>;[10]. Haiti is a low-income country with a poor and fragmented health system. Approximately 40% of the population lacking access to essential health services; only 45 percent of all children (12-23 months) are fully vaccinated. ADDIN EN.CITE <EndNote><Cite><Author>United States Agency International Development (USAIDS)</Author><Year>2017</Year><RecNum>3109</RecNum><DisplayText>[11]</DisplayText><record><rec-number>3109</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530555592">3109</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>United States Agency International Development (USAIDS),</author></authors></contributors><titles><title>Haiti Health Fact Sheet </title></titles><volume>2018</volume><number>14th March 2018</number><dates><year>2017</year></dates><urls><related-urls><url>;[11] Kernicterus and disability related to SNJ is thought common, infants with neonatal jaundice often present late and have limited access to TSB measurement. In 2014, neonatal clinicians working in Haiti, implemented training and a neonatal guideline for the use of a TcB (Drager JM-103) donated to the neonatal unit. The aim of this study was to evaluate the agreement between TSB and TcB levels measured from covered skin during phototherapy in Haitian newborn infants. MethodsSetting This was a prospective, observational and pragmatic study conducted in a small rural hospital, Hospital Convention Baptiste d’Haiti (HCBH), Cap Ha?tien, Haiti between February and May 2017. The hospital has approximately 1500 deliveries per year and the neonatal unit has capacity for 12 cots with around 40 admissions per month; over 80% born at term. Diagnostic capacity for infants with jaundice is severely limited in this setting. Testing for blood group incompatibility and Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency is not routinely available.Protocol and patients A TcB (JM 103 Drager) guideline was implemented in 2014 with staff training and an adapted version of the UK NICE guidelines ADDIN EN.CITE <EndNote><Cite><Author>Rennie</Author><Year>2010</Year><RecNum>1021</RecNum><DisplayText>[4]</DisplayText><record><rec-number>1021</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1325091358">1021</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rennie, J.</author><author>Burman-Roy, S.</author><author>Murphy, M. S.</author></authors></contributors><auth-address>Elizabeth Garrett Anderson Institute for Women&apos;s Health, University College London NHS Foundation Trust London, London NW1 2BU. janet.rennie@uclh.nhs.uk</auth-address><titles><title>Neonatal jaundice: summary of NICE guidance</title><secondary-title>BMJ</secondary-title></titles><periodical><full-title>BMJ</full-title></periodical><pages>c2409</pages><volume>340</volume><edition>2010/05/21</edition><keywords><keyword>Chronic Disease</keyword><keyword>Health Education</keyword><keyword>Humans</keyword><keyword>Hyperbilirubinemia, Neonatal/therapy</keyword><keyword>Infant, Newborn</keyword><keyword>Jaundice, Neonatal/ therapy</keyword><keyword>Perinatal Care</keyword><keyword>Practice Guidelines as Topic</keyword></keywords><dates><year>2010</year></dates><isbn>1468-5833 (Electronic)&#xD;0959-535X (Linking)</isbn><accession-num>20484363</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[4] for jaundice management used for clinical decision making. The TcB measurements were conducted as per guidance from the manufacturer and after daily calibration ADDIN EN.CITE <EndNote><Cite><Author>Drager</Author><Year>2017</Year><RecNum>3110</RecNum><DisplayText>[12]</DisplayText><record><rec-number>3110</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530609842">3110</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Drager </author></authors></contributors><titles><title>Drager JM-103 Instructions Manual </title></titles><volume>2014 </volume><number>January 2nd</number><dates><year>2017</year></dates><urls><related-urls><url>;[12]. All infants, irrespective of gestational age and less than seven days old were eligible for inclusion. A TcB reading was measured daily as part of routine care and phototherapy commenced based upon UK NICE threshold graphs. Newborns receiving phototherapy were nursed exposed with gauze pads for eye protection. A strip of black tape was placed across the infant’s chest during phototherapy and this was lifted when TcB measurements were taken from the sternum(Figure 1). Black tape was chosen as this was locally available and affordable.Due to limited laboratory capacity to perform TSB levels, a maximum of two infants and two paired samples were enrolled each day. A parallel TSB blood sample obtained by venepuncture was sent to the laboratory. Paired TSB and TcB levels were ideally obtained in the first few days of life as this is the time of highest risk for significant and rapidly rising bilirubin levels. This was not possible for infants admitted from the community or other hospitals at a later age. Laboratory methods Serum samples were analysed daily where possible. A photometric test for direct and total bilirubin using the modified Jenddrassik--Grof Method (Bilirubin D+T liquicolor) was used ADDIN EN.CITE <EndNote><Cite><Author>Gambino</Author><Year>1965</Year><RecNum>3111</RecNum><DisplayText>[13]</DisplayText><record><rec-number>3111</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530610182">3111</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Gambino, S. Raymond</author><author>Golden, Walter R. C.</author><author>Smith, A. William</author></authors><secondary-authors><author>Meites, Samuel</author></secondary-authors></contributors><titles><title>Bilirubin (Modified Jendrassik and Grof)—Provisional</title><secondary-title>Standard Methods of Clinical Chemistry</secondary-title></titles><pages>55-64</pages><volume>5</volume><dates><year>1965</year><pub-dates><date>1965/01/01/</date></pub-dates></dates><pub-location>New York </pub-location><publisher>Elsevier</publisher><isbn>0065-7115</isbn><urls><related-urls><url>;[13].Data collection Data were entered into a Microsoft Office Excel spreadsheet including gestational age (completed weeks), birth weight, gender, hour and age at onset of clinically detected jaundice, onset of phototherapy. Statistical analysis Each newborn was included once and contributed one paired TcB/TSB result. A Bland-Altman difference plot was used to measure agreement between TcB and TSB; bias was calculated as a mean of the differences between the paired TSB and TcB values ADDIN EN.CITE <EndNote><Cite><Author>Bland</Author><Year>1986</Year><RecNum>2048</RecNum><DisplayText>[14]</DisplayText><record><rec-number>2048</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1417006367">2048</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bland, M.J.</author><author>Altman, D.G.</author></authors></contributors><titles><title>Statistical methods for assessing agreement between two methods of clinical measurement </title><secondary-title>The Lancet </secondary-title></titles><periodical><full-title>The Lancet</full-title></periodical><pages>307-310</pages><volume>327</volume><number>8476</number><dates><year>1986</year></dates><urls></urls></record></Cite></EndNote>[14]. All analyses were conducted in STATA version 11 ADDIN EN.CITE <EndNote><Cite><Author>StataCorp LP.</Author><Year>2011</Year><RecNum>3113</RecNum><DisplayText>[15]</DisplayText><record><rec-number>3113</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530612138">3113</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>StataCorp LP.,</author></authors></contributors><titles><title>Stata Statistical Software: Release 11. College Station, TX </title></titles><dates><year>2011</year></dates><urls><related-urls><url>;[15].Ethics approval The study was approved by the Haitian Ministry of Health. As TSB is considered the gold-standard monitoring method, and TcB is a non-invasive test and accepted as routine clinical care in high income countries, ethics approval was not necessary. Results Forty-three infants were enrolled into the study. Eight were excluded as we were unable to obtain TcB/TSB paired measurements due to equipment and laboratory failures. The final analysis included 70 TSB/TcB measurements (paired measurements from 35 neonates). Clinical characteristics of the infants are shown in Table 1. Around two-thirds were ≥35 weeks. Precise gestational week was unavailable. 32/35 (91.4%) were less than five days old and receiving phototherapy. Median (interquartile range) to TcB/TSB sampling was 72 (48-96) hours. Table 1.Total n=35n (%)Gestation (completed weeks)<35≥3512 (34.3)23 (65.7)Sex Male 19 (54.38)Receiving phototherapy at time of testing YesNo32 (91.4)3 (8.6)Age phototherapy started (days)1234≥58 (22.9)2 (5.7)13 (37.2)9 (25.7)3 (8.6)Median day of phototherapy 3 (2-4)Birth weight (g), mean (sd) 2437.5 (856.8)Admitted from community/other hospital 9 (26)A Bland-Altman plot of TcB versus TSB demonstrated good agreement between the methods, with only 1 TcB/TSB pair falling outside of the mean/95% confidence interval (see Figure 2). Overall, TcB overestimates the bilirubin in comparison to TSB [mean difference 11.1 ?mol/L (95% CI -10.2, 32.5)]. At higher bilirubin levels (>250 ?mol/L), TcB tended to underestimate bilirubin in comparison to TSB and the magnitude of the difference increased as demonstrated in Figure 1. The mean difference between TcB and TSB was increased in infants< 35 weeks [16.4 (-24.8, 57.5)] compared to infants≥ 35 weeks 8.4 (-18.5, 35.3). DiscussionTo our knowledge, this is the first reported study conducted in Haitian newborn population comparing TcB/TSB. 35 paired TcB/TSB readings were obtained during phototherapy in a single Haitian neonatal unit where TSB is not readily available. There was good agreement between TSB and TcB measured from the sternum, covered with black tape during phototherapy. TcB generally overestimates TSB but underestimates TSB at higher levels (>250 ?mol/L). Although this means that some infants will receive unnecessary phototherapy, we believe this is an acceptable compromise when the alternative is unreliable visual assessment, delayed diagnosis, treatment and irreversible kernicterus. Rather than place additional pressure for phototherapy devices, as suggested by some authors ADDIN EN.CITE <EndNote><Cite><Author>Olusanya</Author><Year>2017</Year><RecNum>3105</RecNum><DisplayText>[9]</DisplayText><record><rec-number>3105</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530535968">3105</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Olusanya, B. O.</author><author>Emokpae, A. A.</author></authors></contributors><titles><title>Use of Transcutaneous Bilirubin to Determine the Need for Phototherapy in Resource-Limited Settings</title><secondary-title>Neonatology</secondary-title></titles><periodical><full-title>Neonatology</full-title></periodical><pages>324-330</pages><volume>111</volume><number>4</number><dates><year>2017</year></dates><isbn>1661-7819 (Electronic)&#xD;1661-7800 (Linking)</isbn><urls></urls></record></Cite></EndNote>[9], TcB enables clinicians to prioritise the limited resources to those with dangerously high bilirubin levels. These findings have reassured us of the safety of daily TcB screening in our unit, and our protocol guiding the use of TcB in the absence of TSB. In this study, the Draeger JM 103 was validated but there are other available TcB devices with different accuracies. Validation of TcB devices with TSB should be an integral part of implementation. Ongoing manufacturer validation of TcB devices in different income settings, gestation ages and ethnicities is recommended. Additional benefits of TcB include reduced pain to the newborn and blood sampling PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TcmluaXZhczwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+

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ADDIN EN.CITE.DATA [5, 16, 17, 18, 19]. It also allows indirect savings such as manpower and laboratory resources, although the upfront cost of TcB is expensive for most hospitals in the low resource setting and there is an urgent need for more affordable equipment There is no prevalence data for G6PD deficiency in the newborn Haitian population, however available data in older age groups suggests a high prevalence (22.7%) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52b24gRnJpY2tlbjwvQXV0aG9yPjxZZWFyPjIwMTQ8L1ll

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ADDIN EN.CITE.DATA [20]. In the absence of readily available TSB testing, our findings suggest that TcB might be also useful for the?earlier detection of newborn jaundice in the community setting both in the period after birth and following discharge from hospital.The study has several strengths and limitations. We were able to incorporate covering of the sternum with a strip of black tape into routine practice. Inconsistent covering was acknowledged as a limitation in the study by Rylance et al ADDIN EN.CITE <EndNote><Cite><Author>Rylance</Author><Year>2014</Year><RecNum>3075</RecNum><DisplayText>[6]</DisplayText><record><rec-number>3075</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1523782363">3075</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rylance, S.</author><author>Yan, J.</author><author>Molyneux, E.</author></authors></contributors><titles><title>Can transcutaneous bilirubinometry safely guide phototherapy treatment of neonatal jaundice in Malawi?</title><secondary-title>Paediatr Int Child Health</secondary-title></titles><periodical><full-title>Paediatr Int Child Health</full-title></periodical><pages>101-7</pages><volume>34</volume><number>2</number><dates><year>2014</year></dates><isbn>2046-9055 (Electronic)&#xD;2046-9047 (Linking)</isbn><urls></urls></record></Cite></EndNote>[6]. As TcB reflects the yellowish discolouration of blanched skin and subcutaneous tissues rather than intravascular plasma or serum bilirubin concentration, phototherapy and skin pigmentation can theoretically affect results ADDIN EN.CITE <EndNote><Cite><Author>Tan</Author><Year>2003</Year><RecNum>3076</RecNum><DisplayText>[8, 9]</DisplayText><record><rec-number>3076</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1523801575">3076</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Tan, K. L.</author><author>Dong, F.</author></authors></contributors><titles><title>Transcutaneous bilirubinometry during and after phototherapy</title><secondary-title>Acta Paediatr</secondary-title></titles><periodical><full-title>Acta Paediatr</full-title></periodical><pages>327-31</pages><volume>92</volume><number>3</number><dates><year>2003</year></dates><isbn>0803-5253 (Print)&#xD;0803-5253 (Linking)</isbn><urls></urls></record></Cite><Cite><Author>Olusanya</Author><Year>2017</Year><RecNum>3105</RecNum><record><rec-number>3105</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530535968">3105</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Olusanya, B. O.</author><author>Emokpae, A. A.</author></authors></contributors><titles><title>Use of Transcutaneous Bilirubin to Determine the Need for Phototherapy in Resource-Limited Settings</title><secondary-title>Neonatology</secondary-title></titles><periodical><full-title>Neonatology</full-title></periodical><pages>324-330</pages><volume>111</volume><number>4</number><dates><year>2017</year></dates><isbn>1661-7819 (Electronic)&#xD;1661-7800 (Linking)</isbn><urls></urls></record></Cite></EndNote>[8, 9]. For this study the sternum was chosen as previous studies have shown TcB readings was not significantly affected by site covered (e.g. sternum or head) ADDIN EN.CITE <EndNote><Cite><Author>Nagar</Author><Year>2016</Year><RecNum>3090</RecNum><DisplayText>[5, 8]</DisplayText><record><rec-number>3090</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530534883">3090</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nagar, G.</author><author>Vandermeer, B.</author><author>Campbell, S.</author><author>Kumar, M.</author></authors></contributors><titles><title>Effect of Phototherapy on the Reliability of Transcutaneous Bilirubin Devices in Term and Near-Term Infants: A Systematic Review and Meta-Analysis</title><secondary-title>Neonatology</secondary-title></titles><periodical><full-title>Neonatology</full-title></periodical><pages>203-12</pages><volume>109</volume><number>3</number><dates><year>2016</year></dates><isbn>1661-7819 (Electronic)&#xD;1661-7800 (Linking)</isbn><urls></urls></record></Cite><Cite><Author>Tan</Author><Year>2003</Year><RecNum>3093</RecNum><record><rec-number>3093</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530535237">3093</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Tan, K. L.</author><author>Dong, F.</author></authors></contributors><titles><title>Transcutaneous bilirubinometry during and after phototherapy</title><secondary-title>Acta Paediatr</secondary-title></titles><periodical><full-title>Acta Paediatr</full-title></periodical><pages>327-31</pages><volume>92</volume><number>3</number><dates><year>2003</year></dates><isbn>0803-5253 (Print)&#xD;0803-5253 (Linking)</isbn><urls></urls></record></Cite></EndNote>[5, 8] and our results confirm that covering the sternum with black tape produces TcB results comparable to TSB with a smaller mean difference compared to other studies ADDIN EN.CITE <EndNote><Cite><Author>Rylance</Author><Year>2014</Year><RecNum>3075</RecNum><DisplayText>[6]</DisplayText><record><rec-number>3075</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1523782363">3075</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rylance, S.</author><author>Yan, J.</author><author>Molyneux, E.</author></authors></contributors><titles><title>Can transcutaneous bilirubinometry safely guide phototherapy treatment of neonatal jaundice in Malawi?</title><secondary-title>Paediatr Int Child Health</secondary-title></titles><periodical><full-title>Paediatr Int Child Health</full-title></periodical><pages>101-7</pages><volume>34</volume><number>2</number><dates><year>2014</year></dates><isbn>2046-9055 (Electronic)&#xD;2046-9047 (Linking)</isbn><urls></urls></record></Cite></EndNote>[6]. Our findings corroborate studies which demonstrated TcB significantly overestimates TSB among African dark-skinned neonates in contrast to under estimation among white neonates. A further strength of the study is that we used Bland Altman plots to provide an estimation of the imprecision; only two studies in the systematic review reported this ADDIN EN.CITE <EndNote><Cite><Author>Nagar</Author><Year>2016</Year><RecNum>3090</RecNum><DisplayText>[5]</DisplayText><record><rec-number>3090</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1530534883">3090</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nagar, G.</author><author>Vandermeer, B.</author><author>Campbell, S.</author><author>Kumar, M.</author></authors></contributors><titles><title>Effect of Phototherapy on the Reliability of Transcutaneous Bilirubin Devices in Term and Near-Term Infants: A Systematic Review and Meta-Analysis</title><secondary-title>Neonatology</secondary-title></titles><periodical><full-title>Neonatology</full-title></periodical><pages>203-12</pages><volume>109</volume><number>3</number><dates><year>2016</year></dates><isbn>1661-7819 (Electronic)&#xD;1661-7800 (Linking)</isbn><urls></urls></record></Cite></EndNote>[5]. Correlation coefficients do not provide ranges between which TcB can safely be used and a ‘moderate correlation’ has minimal clinical application. The main study limitation was the small numbers; constrained by unreliable laboratory equipment and electrical supplies. We only had 12 infants <35 weeks gestation and therefore cannot draw meaningful conclusions. However, the higher mean difference we found between TcB and TSB among preterm infants<35 weeks has also been reported in other studies and may suggest caution in preterm infants, and those weighing <2.5 kg ADDIN EN.CITE <EndNote><Cite><Author>Maisels</Author><Year>2004</Year><RecNum>3077</RecNum><DisplayText>[21]</DisplayText><record><rec-number>3077</rec-number><foreign-keys><key app="EN" db-id="v59trsspwwwd0cerf5s5wz2usvavpz095vfr" timestamp="1523801912">3077</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Maisels, M. J.</author><author>Ostrea, E. M., Jr.</author><author>Touch, S.</author><author>Clune, S. E.</author><author>Cepeda, E.</author><author>Kring, E.</author><author>Gracey, K.</author><author>Jackson, C.</author><author>Talbot, D.</author><author>Huang, R.</author></authors></contributors><titles><title>Evaluation of a new transcutaneous bilirubinometer</title><secondary-title>Pediatrics</secondary-title></titles><periodical><full-title>Pediatrics</full-title></periodical><pages>1628-35</pages><volume>113</volume><number>6</number><dates><year>2004</year></dates><isbn>1098-4275 (Electronic)&#xD;0031-4005 (Linking)</isbn><urls></urls></record></Cite></EndNote>[21]. Further studies are warranted in this more preterm population. In summary, we have shown a good agreement between TSB and TcB measured from covered skin in dark-skinned infants receiving phototherapy. In the absence of TSB, it is safe to use TcB to screen and guide jaundice management and we recommend TcB screening as part of routine care in LIC neonatal units where TSB is unavailable. Whilst it is more likely to over-treat when TcB <250?mol/L, the opposite is true at higher levels and hence we recommend a laboratory TSB when >250?mol/L, or in the absence of laboratory facilities, to treat with phototherapy as the alternative outcomes are far more dangerous. Whilst easy to use, implement and was well received by local neonatal staff, the upfront cost of a TcB device is expensive and there is an urgent need to improve affordability. ConclusionIn the absence of serum bilirubin in low resource settings, TcB measured from covered skin appears both feasible and safe to guide jaundice treatment during phototherapy. For TcB levels >250?mol, confirmation with serum bilirubin should be performed if available to avoid underestimation.FootnotesContributors: CB and VV identified the need, conceptualised and designed the study. SJ and CM acquired data. VV implemented the device into routine practice and LJ, PT were local leads. SJ wrote the first draft of the manuscript. PT and CH provided administrative and laboratory support enabling the study objectives to be met. CB conducted the statistical analysis and a critical revision of the manuscript. All individuals will be involved in the reporting and dissemination of findings in peer reviewed journals and conferences.Funding: Hope Health Action (HHA), a UK registered non-government organisation (NGO) provided funding. HHA has been providing maternal and infant health care with its local partner hospital Hospital Baptiste d’Haiti (HCBH) since its establishment in peting interests: None declaredAcknowledgementsWe acknowledge the support of Drager for the charitable donation of a Drager JM-103 transcutaneous bilirubinometer. Drager had no involvement in the design and funding of the study or in the interpretation of the study results.Consent: Parental informed verbal consent was obtained for the photo included in Figure 1 Provenance and peer review: Not commissionedEthics: As this was an evaluation of a non-invasive technique (TcB) versus a measurement considered standard and recommended practice internationally (total serum bilirubin) ethics approval was not required nor sought.References ADDIN EN.REFLIST 1.Mwaniki MK, Atieno M, Lawn JE, et al. Long-term neurodevelopmental outcomes after intrauterine and neonatal insults: a systematic review. Lancet. 2012;379:445-452. 2.Slusher TM, Zamora TG, Appiah D, et al. Burden of severe neonatal jaundice: a systematic review and meta-analysis. BMJ Paediatrics Open. 2017;1:e000105. 3.National Institute for Health and Care Excellence. Jaundice in newborn babies under 28 days. CG98 2016. Available from: J, Burman-Roy S, Murphy MS. Neonatal jaundice: summary of NICE guidance. BMJ. 2010;340:c2409. 5.Nagar G, Vandermeer B, Campbell S, et al. Effect of Phototherapy on the Reliability of Transcutaneous Bilirubin Devices in Term and Near-Term Infants: A Systematic Review and Meta-Analysis. Neonatology. 2016;109:203-12. 6.Rylance S, Yan J, Molyneux E. Can transcutaneous bilirubinometry safely guide phototherapy treatment of neonatal jaundice in Malawi? Paediatr Int Child Health. 2014;34:101-7. 7.Nagar G, Vandermeer B, Campbell S, et al. Reliability of transcutaneous bilirubin devices in preterm infants: a systematic review. Pediatrics. 2013;132:871-81. 8.Tan KL, Dong F. Transcutaneous bilirubinometry during and after phototherapy. Acta Paediatr. 2003;92:327-31. 9.Olusanya BO, Emokpae AA. Use of Transcutaneous Bilirubin to Determine the Need for Phototherapy in Resource-Limited Settings. Neonatology. 2017;111:324-330. 10.Philips. BiliChek noninvasive bilirubin assessment tool 2017 [cited 2018 June 19th ]. Available from: States Agency International Development (USAIDS). Haiti Health Fact Sheet 2017 [cited 2018 14th March 2018]. Available from: . Drager JM-103 Instructions Manual 2017 [cited 2014 January 2nd]. Available from: SR, Golden WRC, Smith AW. Bilirubin (Modified Jendrassik and Grof)—Provisional. In: Meites S, editor. Standard Methods of Clinical Chemistry. Vol. 5. New York Elsevier; 1965. p. 55-64.14.Bland MJ, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement The Lancet 1986;327:307-310. 15.StataCorp LP. Stata Statistical Software: Release 11. College Station, TX 2011. 16.Srinivas GL, Cuff CD, Ebeling MD, et al. Transcutaneous bilirubinometry is a reliably conservative method of assessing neonatal jaundice. J Matern Fetal Neonatal Med. 2016;29:2635-9. 17.Grabenhenrich J, Grabenhenrich L, Buhrer C, et al. Transcutaneous bilirubin after phototherapy in term and preterm infants. Pediatrics. 2014;134:2014-1677. 18.Jenke A. Transcutaneous Bilirubinometry for Preterm Infants-Are There More Things to Consider? : J Pediatr. 2016 Jan;168:6-7. 19.Mishra S, Chawla D, Agarwal R, et al. Transcutaneous bilirubinometry reduces the need for blood sampling in neonates with visible jaundice. Acta Paediatr. 2009;98:1916-9. 20.von Fricken ME, Weppelmann TA, Eaton WT, et al. Prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency in the Ouest and Sud-Est departments of Haiti. Acta tropica. 2014 Jul;135:62-6. 21.Maisels MJ, Ostrea EM, Jr., Touch S, et al. Evaluation of a new transcutaneous bilirubinometer. Pediatrics. 2004;113:1628-35. Figure 1 A strip of black tape was placed across the neonates’ sternum during phototherapy and only uncovered for TcB measurements. Figure 2 Bland-Altman plot of TcB versus TSBDotted green line is the mean difference (11.1 ?mol/L); shaded grey areas are bordered by the 95% lower and upper confidence intervals. ................
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