http://informahealthcare.com/jmf ISSN: 1476-7058 (print), 1476-4954 (electronic) J Matern Fetal Neonatal Med, Early Online: 1–3 ! 2014 Informa UK Ltd. DOI: 10.3109/14767058.2014.953923

ORIGINAL ARTICLE

Correlation of transcutaneous bilirubinometry (TcB) and total serum bilirubin (TsB) levels after phototherapy J Matern Fetal Neonatal Med Downloaded from informahealthcare.com by University of Glasgow on 04/16/15 For personal use only.

Ada Juster-Reicher1,2, Orna Flidel-Rimon1,2, Ilya Rozin1,2, and Eric S. Shinwell1,2 1

Department of Neonatology, Kaplan Medical Center, Rehovot, Israel and 2Faculty of Medicine, Hebrew University, Jerusalem, Israel

Abstract

Keywords

Aim: To investigate the correlation between transcutaneous bilirubinometry (TcB) and total serum bilirubin (TsB) in jaundiced infants before and after, but not during phototherapy. Methods: This study prospectively investigated the correlation between TcB and TsB in term and near term infants before and after phototherapy. Results: Overall 673 pairs of measurements (TcB and TsB) were performed on 371 infants of 35 weeks gestation and with birth weight above 2000 g. Of these 337 sets were from 200 infants who had not been treated with phototherapy (Group 1) and 336 measurements from 171 infants taken between 1 h and 5 d after phototherapy (Group 2). The correlation coefficient between TcB and TsB in the whole cohort was r ¼ 0.72. The correlation was low during the first 8 h after phototherapy (r ¼ 0.56), but thereafter the correlation returned to the range of 0.65–0.8. Using the Sobel test, no significant difference was found between the correlation coefficients at the different time periods, with the possible exception of the difference between 1 and 8 h and 9 and 16 h which was of borderline significance with a p value of 0.06. Conclusion: This study demonstrates good correlation between TcB and TsB by 8 h after phototherapy. This adds validity to community-based screening programs employing TcB measurements plotted on TsB nomograms. Such programs may contribute to prevention of tragic cases of bilirubin-induced neurologic damage.

Jaundiced infants, phototherapy, transcutaneous bilirubinometry

Introduction

Methods

Transcutaneous bilirubinometry (TcB) is widely used for screening and monitoring neonatal hyperbilirubinemia, thereby minimizing the need for measurements of total serum bilirubin (TsB). Professional bodies from the UK, USA and Canada all recommend the routine use of TcB in babies of more than 35 weeks and more than 24-hour-old, both before hospital discharge and for determination of the need for phototherapy [1–3]. TcB is considered unreliable during phototherapy because of the blanching of the skin [4]. However, the duration of the blanching effect after discontinuation of phototherapy is less clear. Current guidelines, such as those in use in Israel, mostly advise against the use of TcB in infants at any time after phototherapy [5]. To our best knowledge, there is limited data regarding the validity of TcB after phototherapy [4]. This study describes the correlation between TsB and TcB in term and near-term infants with hyperbilirubinemia. We compared infants with hyperbilirubinemia who did not require phototherapy with infants in the immediate post-phototherapy period.

TcB measurements

Address for correspondence: Dr. Ada Juster-Reicher, Department of Neonatology, Kaplan Medical Center, PO Box 1, Rehovot 76100, Israel. Tel: +97289441218. Fax: +97289441768. E-mail: [email protected]

History Received 2 April 2014 Accepted 8 August 2014 Published online 30 September 2014

TcB was measured at mid-sternum using a Minolta JM-103 jaundice meter, recording the average of three readings. Routine TcB measurements were taken in all infants at discharge and when clinically indicated by skin color. Infants were monitored both during hospital admission and at the jaundice follow-up clinic that is situated within the nursery. A cut-off value of 10 mg% on TcB was considered to be the indication for measurement of TsB. This cut-off was based on earlier data using the same equipment showing that no infants with TcB values below 10 mg% had TsB values that mandated initiation of phototherapy. Indications for phototherapy were based on an Israeli modification (minor) of Bhutani’s hourspecific nomogram using TsB values [5,6]. Data points were recorded during morning shifts in order to assure consistency of measurements. Study population Inclusion criteria were gestational age 35 weeks, birth weight above 2000 g and jaundice requiring assessment. The study infants were born at Kaplan Medical Center in Rehovot, Israel between May 2010 and March 2013. The study was approved by the Institutional Review Board. Two groups of

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A. Juster-Reicher et al.

J Matern Fetal Neonatal Med, Early Online: 1–3

infants were included. Group 1 consisted of infants with jaundice who did not require phototherapy. Group 2 consisted of infants who had completed phototherapy. Statistical analysis Descriptive statistics were generated for both groups. The correlation between TcB and TsB was assessed with Pearson’s correlation coefficients calculated in the overall populations and in sub-groups divided by time periods that were considered to be functionally relevant. The significance of the differences in correlation coefficients was assessed by the Sobel test.

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Results Baseline data Overall, 673 pairs of measurements (TcB and TsB) were performed on 371 eligible infants. Of these, 337 measurements were from 200 infants who had not been treated with phototherapy (Group 1) and 336 measurements were from 171 infants between 1 h and 5 d after phototherapy (Group 2). The infants ranged in age from 2 to 21 d of life. Mean birth weight was 3139 ± 428 g and mean gestational age was 38.6 ± 1.5 weeks. Among them, 57% were male, 92% were of Caucasian origin although the skin color of Israeli infants ranges between white and deep brown. A total of 8% were African with black skin color and 6% were either heterozygotic or homozygotic for G6PD deficiency and 7% had Coombs-positive ABO Incompatibility. And 2% of infants were re-admitted from the jaundice follow-up clinic for phototherapy. No infant required exchange transfusion and there were no cases of bilirubin-induced neurologic damage (BIND). Correlation between TcB and TsB The correlation coefficient between TcB and TsB in the whole cohort was 0.72. Table 1 shows the relationship between chronologic age and the correlation coefficients between TsB and TcB in infants in Group 1 (no photo). The correlation is seen to be highest during the first 3 d of life and falling modestly thereafter. Likewise Table 2 shows that the correlation between TsB and TcB is inversely related to the TsB level. Although this reduction in correlation is well recognized at higher TsB levels, only 1% of TcB values were above 16 mg% and, as all would have had TsB assessments, this lack of correlation is of limited clinical significance. Table 3 shows the correlation coefficients between TsB and TcB in the hours and days after phototherapy. Table 1. Coefficients of correlation (CC) between TcB and TsB in jaundiced infants not requiring phototherapy. Age (days) 1–3 4–6 7–9 Total

n

CC

p value

61 149 126 337

0.82 0.684 0.685 0.72

0.001 0.001 0.001 0.001

CC, correlation coefficient.

The correlation was low during the first 8 h after phototherapy, but thereafter the correlation remained acceptable high in the range of 0.65–0.8. Using the Sobel test, no significant difference was found between the correlation coefficients at the different time periods, with the possible exception of the difference between 1 and 8 h and 9 and 16 h with p ¼ 0.06. No significant interaction was seen between gender, ethnic origin, etiology of the jaundice or gestational age and the degree of correlation between TsB and TcB (data not shown).

Discussion This study demonstrates that the correlation between TsB and TcB returns to pre-phototherapy levels approximately 8 h after discontinuation of therapy, suggesting resolution of the blanching effect of phototherapy. This result is more rapid than the 24-h wait suggested by Tan et al. in a study of 70 infants after phototherapy [4]. The current study includes a much larger sample, thereby improving the statistical power of the findings. The overall correlation coefficient in this study was 0.72, a little lower than previously reported values. Knudsen found a correlation coefficient of 0.85 using the early Minolta Jaundice meter [7]. Other investigators found correlation coefficients between 0.8 and 0.94 depending on site of measurement and skin tone [4,8–11]. The Canadian Pediatric Society recommends correlation coefficients in the range of 0.77–0.93 for reliable clinical use [3]. The slightly lower correlation coefficient in this study may have different explanations. This was a pragmatic study performed in a clinical setting with non-research staff. The variation may reflect inconsistent sampling site, although this is likely to more accurately reflect the true clinical reality. An additional important factor may relate to the broad range of skin color seen in this sample of Israeli infants whose parents originate from all five continents. Engel et al. found that TCB tend to underestimate the values of TSB in Hispanic infants [12]. Maisels et al. found a modestly lower correlation between TSB and TCB in black infants although these differences were not statistically significant [8]. Table 2. Coefficients of correlation (TcB-TsB) grouped by TsB levels. TsB 510 10.1–12 12.1–14 414

N

TsB

TcB

CC

p value

39 90 138 70

9.1 ± 0.9 11.2 ± 0.6 13.1 ± 0.6 15.1 ± 0.8

8.8 ± 1.7 10.8 ± 1.4 11.8 ± 1.3 12.9 ± 1.5

0.665 0.42 0.34 0.44

0.001 0.001 0.001 0.001

Table 3. Coefficients phototherapy. Hours after photo 1–8 9–16 17–24 25–48 49–72 73–96 496 All

of

correlation

(TcB-TsB)

after

n

CC

p value

78 50 56 61 39 21 31 336

0.56 0.73 0.65 0.71 0.72 0.68 0.8 0.72

0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001

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DOI: 10.3109/14767058.2014.953923

Various factors have been shown to influence the correlation between TcB and TsB and these include the make and model of the transcutaneous bilirubinometer (Minolta, JM-102, JM-103), skin color, site of measurement, TsB level and phototherapy [4,9,11,12–14]. Despite these recognized limitations, the combined results of this and other studies support expansion the use of TcB in monitoring jaundice from a limited hospital setting to a widespread and easily available community program for prevention of severe undetected hyperbilirubinemia [8,9,15]. Wainer et al. described a community screening program based on a combination of clinical judgment and TcB screening with clinical management directed by hour-specific bilirubin nomograms. This program led to a reduction in the need for TsB levels, together with earlier (safer) readmissions. There was no change in the overall rate of readmission for jaundice [15]. Bhutani et al. showed that using a cut-off of the 75th percentile on the TsB nomograms, allowed safe use of TcB measurements for screening for the need for re-admission for phototherapy. [9]. Ebbesen found a similar cut-off of the 70th percentile to be safe. [10]. Early hospital discharge within 1–3 d is commonplace in this era of economic stringency. Although community followup is feasible, access to laboratory facilities that are able to provide rapid, easily obtained TsB levels is by no means universally available. Accordingly, TcB screening programs, using TsB nomograms, offer a ‘‘security blanket’’ that may contribute to preventing the tragic cases of BIND. This study, in confirming the reliability of TcB screening even after phototherapy, offers powerful support for the establishment and implementation of community-based TcB screening programs.

Declaration of interest The authors declare no conflicts of interest. The authors alone are responsible for the content and writing of this article.

Correlation between TcB and TsB after phototherapy

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References 1. Neonatal Jaundice – Clinical Guideline. National Collaborating Centre for Women’s and Children’s Health. May 2010. 2. American Academy of Pediatrics, Subcommittee on Hyperbilirubinemia. Clinical guideline: management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics 2004;114:297–316. 3. Fetus and Newborn Committee, Canadian Paediatric Society. Guidelines for detection, management and prevention of hyperbilirubinemia in term and late preterm newborn infants (35 or more week’ gestation) summary Paed Child Health. 2007;12:401–7. 4. Tan KL, Dong F. Transcutaneous bilirubinometry during and after phototherapy. Acta Paed 2003;92:327–31. 5. Kaplan M, Merlob P, Regev R. Israeli guidelines for the management of hyperbilirubinemia and prevention of kernicterus. J Perinatol 2008;28:389–97. 6. Bhutani VK, Johnson L, Sivieri EM. Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. Pediatrics 1999;103:6–14. 7. Knudsen A, Kruce C, Ebbesen F. Detection of hyperbilirubinemia by skin color measurements in icteric neonates at 5 to 14 days of age. Acta Paediatr 1993;82:510–13. 8. Maisels MJ, Ostrea EM, Touch S, et al. Evaluation of a new transcutaneous bilirubinometer. Pediatrics 2004;113:1628–35. 9. Bhutani VK, Gourley GR, Adler S, et al. Noninvasive measurement of total serum bilirubin in a multiracial pre-discharge newborn population to assess the risk of severe hyperbilirubinemia. Pediatrics 2000;106:e17–25. 10. Ebbesen F, Rasmussen LM, Wimberley PD. A new transcutaneous billinometer, BiliCheck, used in the neonatal intensive care unit and the maternity ward. Acta Pediatrica 2002;91:203–11. 11. Wainer S, Rabi Y, Parmar SM, et al. Impact of skin tone on performance of a transcutaneous jaundice meter. Acta Paediatrica 2009;98:1909–15. 12. Engle WD, Jackson GL, Sendelbach D, et al. Assessment of a transcutaneous device in evaluation of neonatal hyperbilirubinemia in a primary hispanic population. Pediatrics 2002;110:61–67. 13. Yasuda S, Itoh S, Isobe K, et al. New transcutaneous jaundice device with two optical paths. J.Perinatal Med 2003;31:81–8. 14. Slusher TM, Angyo IA, Bode-Thomas F, et al. Transcutaneous bilirubin measurements and serum total bilirubin levels in indigenous African Infants. Pediatrics 2004;113:1636–41. 15. Wainer S, Parmar SM, Allegro D, et al. Impact of transcutaneous bilirubinometry program on resource utilization and severe hyperbilirubinemia. Pediatrics 2012;129:77–86.

Correlation of transcutaneous bilirubinometry (TcB) and total serum bilirubin (TsB) levels after phototherapy.

Abstract Aim: To investigate the correlation between transcutaneous bilirubinometry (TcB) and total serum bilirubin (TsB) in jaundiced infants before ...
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