Transcutaneous bilirubin reliability during and after phototherapy depending on skin color.

Measurement of transcutaneous bilirubin (TcB) is a non-invasive, widely used technique to estimate serum bilirubin (SB). However, its reliability in multiethnic populations during and after phototherapy is still controversial even in covered skin. The aim of this study was to determine the reliability of TcB in covered (cTcB) and exposed (eTcB) skin during and after phototherapy in a multiethnic population of term and preterm neonates according to Neomar's neonatal skin color scale. Prospective, observational study comparing SB and TcB. We determined SB when clinically indicated and, at the same time, measured cTcB under a photo-opaque patch and eTcB next to it with a jaundice meter (Dräger JM-105TM). All dyads TcB-SB were compared, both globally and according to skin color. We obtained data from 200 newborns (color1: 44, color2: 111, color3: 41, color4: 4) and compared 296 dyads TcB/SB. Correlation between cTcB and SB is strong during (0.74-0.83) and after (0.79-0.88) phototherapy, both globally and by color group. The SB-cTcB bias depends on gestational age during phototherapy and on skin color following phototherapy. The correlation between eTcB and SB during phototherapy is not strong (0.54), but becomes so 12 h after discontinuing phototherapy (0.78).  Conclusions: Our study supports the reliability of cTcB to assess SB during and after phototherapy, with differences among skin tones after the treatment. The use of cTcB and Neomar's scale during and mainly after phototherapy may help reduce the number of blood samples required. What is Known: • Controversies exist on the reliability of jaundice meters during and after phototherapy in covered skin. Only a few studies have analyzed their accuracy in multiethnic populations, but none has used a validated neonatal skin color scale. What is New: • We verified correlation between serum and transcutaneous bilirubin in covered skin in a multiethnic population depending on skin color based on our own validated neonatal skin color scale during and after phototherapy.

Accuracy of transcutaneous bilirubinometry in term infants after phototherapy: a prospective observational study.

OBJECTIVE: To test the accuracy of transcutaneous bilirubinometry (TcB) in neonates 12 h after discontinuing phototherapy. STUDY DESIGN: In a prospective study of 91 neonates at ≥35 weeks of gestation, paired measurements of total serum bilirubin (TSB) and TcB were obtained 12 h after discontinuation of phototherapy. TcB measurements were obtained on the uncovered skin of the sternum and the covered skin of the lower abdomen. Bland-Altman plots were used to evaluate agreement between TSB and TcB. RESULTS: TcB was found to systematically underestimate TSB on both covered and uncovered skin. The smallest but statistically significant difference between TSB and TcB was found on the covered lower abdomen (-1.03, p < .0001) compared with the uncovered skin of the sternum (-1.44, p < .0001). The correlation between TSB and TcB was excellent on both covered (r = 0.86, p < .001) and uncovered skin (r = 0.90, p < .001). Bland and Altman plots showed poor agreement between TcB and TSB. CONCLUSIONS: This study demonstrated excellent correlation between TcB and TSB 12 h after phototherapy but poor TcB-TSB agreement. TcB cannot be reliably used in neonates exposed to phototherapy.

Early-Term Neonates Demonstrate a Higher Likelihood of Requiring Phototherapy Compared to Those Born Full-Term.

Early-term neonates (with a gestational age (GA) of 37 and 0/7 weeks to 38 and 6/7 weeks) face higher morbidities, including respiratory and neurodevelopmental issues, than full-term (39 and 0/7 weeks to 40 and 6/7 weeks) infants. This study explores whether hyperbilirubinemia necessitating phototherapy also differs between these groups. A retrospective study was conducted on neonates born from January 2021-June 2022, excluding those with specific conditions. Evaluated factors included GA, birth weight, bilirubin levels, glucose-6-phosphate dehydrogenase (G6PD) deficiency, and feeding type, with phototherapy given as per AAP guidelines. Of 1085 neonates, 356 met the criteria. When stratifying the neonates based on the need for phototherapy, a higher proportion of early-term neonates required phototherapy compared to full-term (p < 0.05). After factoring in various risks (GA; birth weight; gender; feeding type; G6PD deficiency; transcutaneous bilirubin levels at 24 h and 24-48 h postpartum; maternal diabetes; and the presence of caput succedaneum or cephalohematoma), early-term neonates were more likely to need phototherapy than full-term babies (OR: 2.15, 95% CI: 1.21 to 3.80). The optimal cut-off for transcutaneous bilirubin levels 24-48 h postpartum that were used to predict phototherapy need was 9.85 mg/dl. In conclusion, early-term neonates are at a greater risk for developing jaundice and requiring phototherapy than full-term neonates. Monitoring bilirubin 24-48 h postpartum enhances early prediction and intervention.

Transcutaneous bilirubin measured on protected skin during phototherapy in term and preterm neonates.

BACKGROUND: Transcutaneous bilirubin (TCB) measurement is a simple, painless, and time-saving alternative for the assessment of TSB (total serum bilirubin) levels. However, TCB measurements obtained during phototherapy can yield inaccurate results. We evaluated the effectiveness of TCB measurements obtained from protected skin areas in patients who underwent phototherapy. METHODS: This prospective study included neonates delivered at a gestational age of ≥340/7 weeks. TCB measurements were performed at the forehead and the lower end of the sternum using a JM-105 device. Simultaneously, blood samples were collected to determine TSB levels. During phototherapy, the forehead was covered with a photo-opaque patch. TSB and TCB were measured before, during, at the end of, and after phototherapy. RESULTS: In total, 200 neonates, including 110 (55 %) term and 90 (45 %) late preterm infants, were enrolled. Of these neonates, 162 (81 %) were Turkish while 38 (19 %) were refugees from Syria and Iraq. Notably, no statistically significant differences were observed in the TSB and TCB values between the Turkish and refugee groups (p > 0.05). Bland-Altman analysis was conducted between the TCB values obtained from the covered forehead area and TSB values; the analysis revealed moderate, high, and excellent agreements for the first bilirubin measurement and at the end of phototherapy, before phototherapy, and for the second and rebound bilirubin measurements, respectively. Regarding intraclass correlation coefficients, values >0.95, 0.94-0.85, 0.84-0.70, and < 0.7 indicated perfect, high, moderate, and unacceptable compatibilities, respectively. Although a significant association was observed between pre-phototherapy TCB obtained from the sternum and TSB levels, no significant associations were observed during phototherapy. CONCLUSIONS: Our findings indicate that the consistency observed between TCB measurements obtained from the protected skin areas and TSB values can be used to monitor phototherapy effectiveness, particularly in late preterm/term infants and those with darker skin tones. Furthermore, this approach can aid in guiding decisions related to treatment termination, evaluating rebound bilirubin levels, minimizing costs, and providing a less invasive testing option.

Feasibility and acceptability of home-based neonatal hyperbilirubinemia screening by community health workers using transcutaneous bilimeters in Bangladesh.

BACKGROUND: Universal screening for neonatal hyperbilirubinemia risk assessment is recommended by the American Academy of Pediatrics to reduce related morbidity. In Bangladesh and in many low- and middle-income countries, there is no screening for neonatal hyperbilirubinemia. Furthermore, neonatal hyperbilirubinemia may not be recognized as a medically significant condition by caregivers and community members. We aimed to evaluate the acceptability and operational feasibility of community health worker (CHW)-led, home-based, non-invasive neonatal hyperbilirubinemia screening using a transcutaneous bilimeter in Shakhipur, a rural subdistrict in Bangladesh. METHODS: We employed a two-step process. In the formative phase, we conducted eight focus group discussions with parents and grandparents of infants and eight key informant interviews with public and private healthcare providers and managers to explore their current knowledge, perceptions, practices, and challenges regarding identification and management of neonatal hyperbilirubinemia. Next, we piloted a prenatal sensitization intervention and home-based screening by CHWs using transcutaneous bilimeters and evaluated the acceptability and operational feasibility of this approach through focus group discussions and key informant interviews with parents, grandparents and CHWs. RESULTS: Formative findings identified misconceptions regarding neonatal hyperbilirubinemia causes and health risks among caregivers in rural Bangladesh. CHWs were comfortable with adoption, maintenance and use of the device in routine home visits. Transcutaneous bilimeter-based screening was also widely accepted by caregivers and family members due to its noninvasive technique and immediate display of findings at home. Prenatal sensitization of caregivers and family members helped to create a supportive environment in the family and empowered mothers as primary caregivers. CONCLUSION: Adopting household neonatal hyperbilirubinemia screening in the postnatal period by CHWs using a transcutaneous bilimeter is an acceptable approach by both CHWs and families and may increase rates of screening to prevent morbidity and mortality.

Feasibility analysis of TCB, hs-CRP, and UCB/ALB as outcome measures for dynamic assessment during phototherapy of neonates with Hyperbilirubinemia.

Hyperbilirubinemia (HY) is a common condition in neonates that requires phototherapy treatment. This study aimed to evaluate the effectiveness of transcutaneous bilirubin measurements (TCB), hypersensitive C-reactive protein (hs-CRP), and unconjugated bilirubin (UCB)/albumin (ALB) as indicators of HY during neonatal phototherapy. A research group of 67 neonates with pathological HY and a control group of 55 healthy neonates were selected from a hospital between June 2020 and May 2021. TCB, hs-CRP, and UCB/ALB tests were performed before, during (at 3 days of treatment), and after (at 6 days of treatment) phototherapy in the research group and at admission in the control group. The study also included a 1-year prognostic follow-up on the research group. The study observed the difference in TCB, hs-CRP, and UCB/ALB test results between both groups and their assessment effect on adverse reactions, treatment effects, and poor prognosis in phototherapy. TCB, hs-CRP, and UCB/ALB levels were higher in the research group than in the control group and gradually decreased during phototherapy (P < 0.05). The combined TCB, hs-CRP, and UCB/ALB assay had 100.0% sensitivity and 64.58% specificity (P < 0.001) for predicting adverse reactions, 88.24% sensitivity and 80.00% specificity (P < 0.001) for predicting the effect of phototherapy, and 90.91% sensitivity and 88.89% specificity (P < 0.001) for predicting poor prognosis. The combined TCB, hs-CRP, and UCB/ALB assay showed superior assessment of adverse effects, clinical outcomes, and poor prognosis in HY neonates treated with phototherapy. TCB, hs-CRP, and UCB/ALB could be used as dynamic disease assessment indicators for HY to better prevent and treat the occurrence of HY.

Transcutaneous bilirubin-based screening reduces the need for blood exchange transfusion in Myanmar newborns: A single-center, retrospective study.

Background: Neonatal hyperbilirubinemia is a significant health problem in Myanmar. We introduced transcutaneous bilirubin (TcB) measurements in 2017 and developed an hour-specific TcB nomogram for early detection and treatment of hyperbilirubinemia in Myanmar neonates. This study aimed to evaluate whether our screening method for hyperbilirubinemia decreased the requirement of blood exchange therapy (ET). Methods: This retrospective cohort study was conducted at the Central Women's Hospital, Yangon. Two groups were included as follows: group 1 (control group; comprising infants born in 2016 and screened on the basis of Kramer's rule), and group 2 (intervention group; comprising infants born in 2019 and screened by TcB measurement using a nomogram). The number of ETs was analyzed based on causes of hyperbilirubinemia and number of days after birth. Results: Groups 1 and 2 comprised 12,968 and 10,090 infants, respectively. Forty-six and two infants in Groups 1 and 2, respectively, required an ET. The odds ratio for ET was 18.0 (Group 1 to Group 2; 95% confidence interval [CI]: 4.8-67.1; p = 0.000). Serum bilirubin values at the time ET was administered were significantly higher in Group 1 than those in Group 2 (median: 23.0 and 16.8, respectively). Conclusion: The management of hyperbilirubinemia using our screening method (TcB Nomogram) can effectively reduce the need for ET in neonates in Myanmar.

Gestational Age-Specific Nomogram of Transcutaneous Bilirubin in First 120 h of Life for Term and Late Preterm Indian Neonates.

OBJECTIVE: To create a nomogram based on transcutaneous bilirubin values (TCB) in first week of life for term and late preterm (>34 weeks) neonates. METHODS AND DESIGN: Prospective longitudinal study. SETTING: Four tertiary-care teaching hospitals (one each in eastern and southern India, two in northern India) between February 2019 and March 2020. PARTICIPANTS: A total of 2492 term and late preterm (>34 weeks) neonates. INTERVENTION: Bilirubin was measured by transcutaneous bilirubinometer (Drager JM-105, Germany) in all neonates in pre-specified times of the day, 12 hourly every day since birth till discharge between 48 and 72 h, and data were recorded in epochs of 6 hourly intervals. Post-discharge, all neonates were called for review in next 48 h. OUTCOME MEASURES: Primary-TCB in first week of life. Secondary-factors having significant association with significant hyperbilirubinaemia requiring phototherapy. RESULTS: Total of 2492 neonates (males 1303 and female 1189), with a total of 14 162 TCB recordings were analysed and mean hourly bilirubin (TCB) at hourly intervals till 120 h and then daily bilirubin values on Days 6 and 7 were tabulated. We have constructed hour-specific bilirubin nomogram with percentiles as per gestational age in term and near-term Indian neonates till 120 h of life. Amongst the known risk factors, delayed cord clamping, primipara and breastfeeding jaundice had significant association for hyperbilirubinaemia needing phototherapy. CONCLUSIONS: We have created gestation-specific nomogram of TCB levels in 6 hourly intervals for the first 120 postnatal hours, obtained from a large predominantly breast fed healthy, term and near-term Indian neonates.

A Prospective Comparison of Serum and Transcutaneous Bilirubin in Indian Neonates.

The objective of this study was to compare the transcutaneous bilirubin (TcB) with total serum bilirubin (TSB) and to find out the effect of phototherapy on correlation of TcB and TSB during and after phototherapy in Indian neonates. Prospective observational study was performed at neonatal intensive care unit of Uttar Pradesh University of Medical Sciences, Saifai, Etawah, India. Blood samples for TSB estimation of 276 jaundiced neonates were sent, and simultaneously, TcB was measured at forehead and sternum on admission and 12 hourly till discontinuation of phototherapy as per the American Academy of Pediatrics nomogram chart and their correlation was assessed. The effect of phototherapy on correlation of TcB and TSB during and after phototherapy was also observed. The correlation between TSB and TcB was linear and significant for the entire study population over forehead (Pearson's r = 0.802, R 2 = 0.644, p < 0.001) as well as over sternum (Pearson's r = 0.825, R 2 = 0.681, p < 0.001) before starting the phototherapy. This correlation becomes slightly lower for TSB versus TcB forehead (Pearson's r = 0.753, R 2 = 0.568, p < 0.001) and for TSB versus TcB sternum (Pearson's r = 0.754, R 2 = 0.569, p < 0.001) after giving phototherapy for at least 24 hours. The correlation coefficients for TSB versus TcB measurements over forehead and sternum were 0.758 and 0.806, respectively, after 36 hours of phototherapy. TcB measurements using the transcutaneous bilirubinometer correlate closely with TSB levels, so it can be used as an easy and rapid noninvasive method of bilirubin measurement in jaundiced neonates.

Can serum albumin level affect the transcutaneous bilirubinometry in term neonates?

BACKGROUND: Jaundice is the quite common benign condition in neonates, but due to its potential toxicity, neonates must be monitored. This study was aimed to evaluate the effect of serum albumin level on the transcutaneous bilirubin (TcB) measurements in term neonates with unconjugated hyperbilirubinemia. METHODS: Serum albumin and total serum bilirubin (TSB) of 252 jaundiced term neonates were estimated and simultaneously TcB was measured over sternum and the effect of serum albumin on TcB measurements was evaluated. RESULTS: The correlation between TSB and TcB was linear and significant for the entire cohort. When this correlation was studied separately in the groups with different albumin levels, maximum correlation (r = 0.888, R2 linear = 0.789, p < 0.001) was observed in group 1 with hypo-albuminemia followed by in group 2 with normal albumin levels (r = 0.854, R2 linear = 0.729, p < 0.001) and group 3 with higher albumin levels (r = 0.809, R2 linear = 0.689, p < 0.001). Bland-Altman plot analysis of whole study population demonstrate good agreement between TSB and TcB [95% CI = -0.038 to 0.493 mg/dL, 17/252 = 6.75% outside the limits of agreement, Mean difference = 0.227]. This analysis in different groups also show good agreement between TSB and TcB. CONCLUSIONS: The correlation between the TSB and TcB may affected by serum albumin level. Therefore, transcutaneous bilirubinometry is not able to replace invasive TSB measurement. However, in the absence of TSB it could be an alternative to measure the level of bilirubin in term neonates.

Which Is More Accurate: Transcutaneous Bilirubin Measurement on the Forehead or Sternum?

BACKGROUND: The accuracy and reliability of noninvasive methods of neonatal jaundice assessment are not completely obvious, including which area of the body is more suitable to estimate actual bilirubin with transcutaneous bilirubinometry (TCB). METHODS: This cross-sectional study compares the accuracy of three noninvasive methods for neonatal jaundice estimation included visual estimation, TCB on the forehead, and TCB on the sternum. The mean and standard deviation describe quantitative variables. In addition to analytical analysis, we used the linear regression test to evaluate the association of different variables with the accuracy of TCB as well as paired t test for comparing the TCB results on the sternum with the forehead before and after phototherapy. For all statistical tests, a P value less than 0.05 was considered as significant. RESULTS: We enrolled 100 neonates with a mean age (±SD, standard deviation) of 6.5±1.9 days (range 2-11 days) in our study. The mean gestational age (GA) of the participants was 38.94 weeks±1.00 w SD, and their mean (±SD) weight was 3302 g (±315.60). The mean (mg/dL)±SD for bilirubin level by clinical estimation of jaundice, TCB on the forehead and TCB on the sternum were 17.35±2.88, 17.23±1.63, and 17.77±1.58, respectively. Also, comparing mean differences before and after phototherapy showed that TCB on the sternum is a good predictor for neonatal jaundice before phototherapy (0.539 vs. 0.348). CONCLUSION: TCB on the sternum is more predictive than the forehead, especially before phototherapy, to assess the need for treatment in outpatient settings.

Correlation of transcutaneous bilirubin level of shielded skin and total serum bilirubin level after phototherapy in premature infants / 中国新生儿科杂志

Objective:To study the correlation between transcutaneous bilirubin (TcB) level measured from shielded skin and total serum bilirubin (TSB) level after phototherapy in premature infants.Methods:From July 2019 to July 2021,preterm infants with jaundice admitted to the Department of Neonatology of our hospital and received phototherapy were prospectively enrolled in the study. The infants were assigned into 26~31w group, 32~34w group and 35~36w group according to their gestational ages. During phototherapy, the forehead, the chest and the perineum were shielded. TcBs were measured at the above mentioned areas three times each before and after phototherapy and TSB was measured from venous blood samples.Results:A total of 306 premature infants were included, with 51 cases in 26~31w group, 126 cases in 32~34w group and 129 cases in 35~36w group. Before phototherapy, TcBs of the forehead, the chest and the perineum of all infants were correlated with TSB ( r=0.699, 0.913, 0.734, P<0.001) with TcB of the chest showed the best correlation. A linear regression equation was established using the TSB before phototherapy and the TcB of the chest: TSB=0.634+0.912TcB. After phototherapy, TcBs of the forehead, the chest and the perineum of all infants were also correlated with TSB ( r=0.586, 0.879, 0.690, P<0.001) with TcB of the chest showed the best correlation and the linear regression equation was TSB=1.910+0.736TcB. Conclusions:For preterm infants with gestational age of 26~36w, TcB of the shielded chest skin after phototherapy is correlated with TSB and a linear regression model can be established.

Effectiveness of Transcutaneous Bilirubin Measurement in High-Risk Neonates and to Evaluate Validity of Transcutaneous Bilirubin With Total Serum Bilirubin Levels in Both Low and High-Risk Neonates at a Tertiary Care Center in a Developing Country.

Objectives To evaluate the usefulness of transcutaneous bilirubin (TcBR) nomogram in high-risk neonates and to identify the validity of TcBR and total serum bilirubin (TsBR) in both low and high-risk neonates to guide management in under-resourced settings. Methodology A cross-sectional study was conducted at the well-baby nursery of a tertiary care center in Karachi, Pakistan. All neonates admitted in the well-baby nursery with jaundice were stratified into high and low-risk groups. Eighty-seven neonates were included in the low-risk group and 121 neonates in the high-risk group. The usefulness of the TcBR nomogram in high-risk neonates and the validity of TcBR and TsBR in both low and high-risk neonates were determined through sensitivity and specificity analysis. Results The correlation coefficients (r) were found to be comparable in the high-risk group (r = 0.82, p < 0.001) and the low-risk group (r = 0.87, p < 0.001). The specificity of cutaneous bilirubin measurement based on bilirubin levels in the high-risk group was higher (93.0%) than that of the low-risk group (90.1%). However, the sensitivity was found to be lower (60.0%) in the high-risk group compared to the low-risk group (68.8%). The mean value of TsBR was equal in both groups. The mean TcBR in the high-risk group was 10 ± 2.3 compared to 11 ± 2.1 in the low-risk group. Phototherapy was given in 67.0% of the high-risk cases and 41.4% of the low-risk cases. Bland Altman analysis was also performed to depict the relationship between TcBR and TsBR measurements. Conclusion The TcBR nomogram was effective in high-risk neonates and also had validity in both high and low-risk neonates. A phototherapy-driven protocol based on TcBR would be a cost-effective and useful tool in the identification and management of neonatal jaundice in both high and low-risk groups in developing countries like Pakistan.

Decision Accuracy and Safety of Transcutaneous Bilirubin Screening at Intermountain Healthcare.

OBJECTIVE: To quantify the risk that transcutaneous bilirubin (TcB) screening would fail to recommend phototherapy for a neonate who would have qualified for it if total serum bilirubin (TSB) screening were used. STUDY DESIGN: We conducted a quality improvement project where simultaneous TcB and TSB were obtained on neonates ≥35 weeks of gestation during birth hospitalizations in our hospital system. Using our Utah bilirubin management algorithm, we quantified the risk that TcB screening would fail to identify the need for a confirmatory TSB when TSB screening alone would have revealed that phototherapy was indicated. RESULTS: In 3 hospitals, we obtained 727 paired TcB/TSB measurements. Two instances utilized a blood gas radiometer for TSB, and 725 utilized the clinical laboratory-based TSB method. One of the 727 instances had a TcB indicating NO PHOTOTHERAPY, when the simultaneous TSB indicated PHOTOTHERAPY NEEDED. The TSB from that instance was 1 of the 2 from the blood gas radiometer. We estimate the risk of such an error occurring is 1.4 per 1000 TcB measurements (95% CI 0.03-7.6 per 1000). When only the laboratory TSB is used, we estimate the risk of such an error occurring to be 0 per 1000 TcB measurements (95% CI 0.0-5.1 per 1000). CONCLUSIONS: Using TcB for screening at the birth hospital can identify those qualifying for phototherapy, using the Utah guidelines, with 1 of 727 neonates with a blood gas bilirubin and none of 725 with a laboratory-based analysis misidentified as not needing phototherapy when by TSB they did.

Predictability of transcutaneous bilirubinometry in late preterm and term infants at risk for pathological hyperbilirubinemia.

BACKGROUND: The aim was to assess the predictability of transcutaneous bilirubinometry in late preterm and term neonates at risk for pathological hyperbilirubinemia, and to identify the neonatal population in which transcutaneous bilirubin most accurately predicts serum bilirubin level (SB, mg/dl). METHODS: The correlations between transcutaneous bilirubin (TCB, mg/dl) and SB in different neonatal population subsets; and between ΔTSB (TCB-SB) and relevant neonatal variables and clinical groups were analyzed. RESULTS: TCB correlated with SB (r = 0.82, p < 0.05) in the cohort (n = 350) and in population subsets (r = 0.81-0.9, p < 0.001). Black infants with gestational age (GA) >35 weeks and chronological age (CA) >3 days recorded strongest correlation (r = 0.9, p < 0.001) followed by Blacks, and non-Black infants with CA >3 days and GA >35 weeks. ΔTSB was positive in Blacks, and in infants with CA <3 days, or with no phototherapy. ΔTSB was negative in non-Blacks, in infants with positive direct Coombs test (DC+) or those receiving phototherapy. Black race [beta (SE) = 1.3(0.33), p < 0.001] had positive, while CA [beta (SE) =-1.74 (0.36), p < 0.001], DC + status [beta (SE) =-0.72 (0.25), p = 0.004] and receipt of phototherapy [beta (SE) =-0.84 (0.21), p < 0.001] each had negative correlation with ΔTSB. ΔTSB for Blacks was >Whites, Hispanics and Asians. CONCLUSION: SB is best predicted by TCB in Black infants with CA over 3 days and GA over 35 weeks. Variability in SB estimation by TCB is race, CA and immune mediated hemolysis specific.

Analysis of clinical cross-control trial results of an smartphone application in screening neonatal jaundice / 中华实用儿科临床杂志

Objective:To evaluate the correlation, consistency and safety of an smartphone application (APP) in screening neonatal jaundice using the smartphone based on the image-based bilirubin (IBB) and transcutaneous bilirubin (TcB).Methods:From July to October 2018, neonates with the age ≤28 d and gestational age ≥35 weeks who were admitted to Department of Neonatal and Obstetrics, Xuzhou Central Hospital without blue light phototherapy were recruited.They were randomly divided into two groups to measure the jaundice value of skin in front of sternum by a cross-control analysis.Jaundice level in group Ⅰ was first measured using the Nezhabaobei? APP in iPhone 6, and then measured using the JM-103 transcutaneous jaundice instrument as the control device.In group Ⅱ, jaundice level was sequencially measured by the control device and the Nezhabaobei? APP.Sex, age, gestational age, birth weight and the mean value of three consecutive tests were recorded.The Pearson′s correlation analysis, Bland-Altman plots consistency analysis, t test and receiver operating characteristic (ROC) curve were used for statistical analysis. Results:A total of 185 eligible neonates were enrolled, including 99 males and 86 females, with the median age of 5 d (3-8 d), gestational age of (37.6 ± 1.7) weeks, and birth weight of (2 950 ± 645) g. There were good correlation ( r=0.860, P<0.05) and consistency (95.1% of the samples fall within the 95% consistency interval) between IBB and TcB.Good correlation and consistency were also yielded in subgroup analyses based on the sex, age, gestational age and birth weight.The consistency was better in subgroups of ≤7 d, >37 weeks and>2 500 g. The ability of IBB to predict TcB>256.5 μmol/L was better than that of TcB>171.0 μmol/L.The area under the ROC curve was 0.93, the cut-off value was 232.6 μmol/L, the sensitivity was 96.7%, and the specificity was 82.6%.The difference of the mean values of IBB and TcB detected for 3 times was significantly lower than that obtained in the first measurement of IBB and TcB [(12.0 ± 34.4) μmol/L vs.(14.4 ± 38.6) μmol/L, P=0.038]. There were no adverse events and no defects in the device itself. Conclusions:There are good correlation and consistency between IBB and TcB.The ability of IBB to predict TcB>256.5 μmol/L is better than that of TcB>171.0 μmol/L, which is safe in clinical use.

The forehead is a better site than the sternum to check transcutaneous bilirubin during phototherapy in sick infants.

BACKGROUND: To confirm the accuracy of transcutaneous bilirubin (TcB) in the neonatal intensive care unit both with and without phototherapy, and compare forehead and sternum as the TcB assessment site. METHODS: We simultaneously assessed the total serum bilirubin (TSB) and TcB at the forehead and sternum, using a JM-103 bilirubinometer. We analyzed the correlation between the TSB and TcB assessed at the forehead and sternum, with measurements classified as 'without phototherapy' (before phototherapy and > 24 hours after phototherapy discontinuation) and 'with phototherapy' (after 24 hours of phototherapy). RESULTS: There were 1,084 paired forehead and sternum TcB measurements, with the corresponding TSB measurement, from 384 infants. Their mean gestational age of 35.4 ± 3.2 weeks (62% were preterm) and a mean birth weight of 2434 ± 768 grams, and TSB was 6.61 ± 3.56 mg/dL. Without phototherapy, TcB values at the forehead and sternum were correlated well to the TSB value (r = 0.925 and 0.915, respectively). With phototherapy, TcB values at the forehead and sternum were significantly correlated with the TSB value, but TcB at the forehead (r = 0.751) was a better match to the TSB than was TcB at the sternum (r = 0.668). Additionally, Bland-Altman plots showed a greater degree of underestimation of the TSB by TcB at the sternum with phototherapy. CONCLUSIONS: TcB was more accurate in infants not receiving phototherapy. During phototherapy, it is better to assess TcB at the forehead rather than at the sternum.

Investigation of the relationship between cord clamping time and risk of hyperbilirubinemia.

BACKGROUND: Although the relationship between umbilical cord clamping time and various parameters such as hemoglobin (Hb) levels, iron deficiency, and risk of neonatal jaundice has previously been studied, to the best of our knowleadge there have been no studies investigating the relationship between cord clamping time and the risk of significant hyperbilirubinemia. We aimed to investigate the relationship between the time of umbilical cord clamping and transcutaneous bilirubin (TcB) measurements made on various postnatal hours, Hb and serum total bilirubin (STB) levels measured on postnatal 4th day, and the risk of development of significant hyperbilirubinemia requiring phototherapy treatment. METHODS: Eligible newborns were divided into two groups on the basis of the time of cord clamping: those clamped late (60 seconds or more; Group I) and those clamped early (less than 60 seconds; Group II). Groups were compared with respect to the parameters of cord Hb, postnatal TcB measurements at 6th, 48th, 96th and 168th hours, and 96th hour Hb, STB and direct bilirubin levels. RESULTS: TcB levels at the 96th and 168th hour were significantly higher in Group I when compared to Group II (p < 0.001 and p < 0.001, respectively). The 96th hour STB level was significantly higher in Group I when compared to Group II (p < 0.001). The need of phototherapy requirement was higher in Group I when compared to Group II (p=0.001). Increase in cord blood Hb for each 1 gr/dl caused a 3.94-fold increased risk in the requirement of phototherapy treatment. Cord clamping time showed statistically significant positive correlations with both cord blood and 96th hour venous Hb levels, with both 96th hour and 168th hour TcB levels, and with 96th hour STB levels. CONCLUSIONS: Newborns whose cords are clamped late should be followed up closely with respect to high postnatal bilirubin levels and other risks associated with significant hyperbilirubinemia requiring phototherapy treatment.

Transcutaneous bilirubin level to predict hyperbilirubinemia in preterm neonates.

Background: Hyperbilirubinemia is common in neonates, with higher prevalence among preterm neonates, which can lead to severe hyperbilirubinemia. Assessment of total serum bilirubin (TSB) and use of a transcutaneous bilirubinometer (TcB) are existing methods to identify and predict hyperbilirubinemia. This study aimed to determine TcB cut-off values during the first day for preterm neonates to predict hyperbilirubinemia at 48 and 72 hours. Methods: A total of 90 neonates born ≤35 weeks were included in the study. They were divided into two groups (Group I: 1000-1500 grams; Group II: 1501-2000 grams). The bilirubin level was measured on the sternum using TcB at the ages of 12, 24, and 72 h. TSB measurements were taken on the third day or if TcB level reached ± 1.24 mg/dL phototherapy threshold and if TcB showed abnormal results (Group I: 5.76-8.24 mg/dL; Group II: 8.76-11.24 mg/dL). Hyperbilirubinemia was defined as TSB ≥7 mg/dL for group I and >10 mg/dL for group II. Results: In total, 38 group I neonates and 48 group II neonates were observed. Almost half of neonates in group I (44.7%) were suffering from hyperbilirubinemia at the age of 48 hours, with 45.8% of group II at the age of 72 hours. To predict hyperbilirubinemia at the age of 48 hours, the best 24-hour-age TcB cut-off values were calculated to be 4.5 mg/dL for group I and 5.8 mg/dL for group II. To predict hyperbilirubinemia at the age of 72 hours, we determined 24-hour-age TcB value of 5.15 mg/dL for group II. Conclusion: TcB values in the early days of life can be used as hyperbilirubinemia predictors on the following days for preterm neonates. Close monitoring should be managed for those with TcB values higher than the calculated cut-off values.

Accuracy of the Bilicare™ transcutaneous bilirubinometer as the predischarge screening tool for significant hyperbilirubinemia in healthy term and late preterm neonates.

Background: The Bilicare™ is a new device that measures transcutaneous bilirubin (TcB) level at the ear pinna. There are only few studies which have evaluated its accuracy in clinical practice.Objective: This study aims to determine the accuracy of Bilicare™ as a predischarge screening tool in late preterm and term neonates and to define the optimal cutoff point for determining the need to measure total serum bilirubin (TSB).Methods: The 35 weeks' gestation or more and healthy neonates who underwent predischarge TSB measurement were enrolled. Bilicare™ TcB was measured within 30 minutes of blood sampling. Paired TcB and TSB data were analyzed.Results: We collected 214 paired samples. Mean age (SD) at TcB measurement was 57.17 (7.47) hours. Mean TSB (SD) was 9.79 (2.83) mg/dL. TcB showed a significant correlation with TSB (r = 0.84, r2 = 0.7). The mean difference (SD) between TcB and TSB was 0.7 (0.21) mg/dL (95%CI 0.49-0.91). TcB tended to overestimate TSB level at the TSB values of <12 mg/dL but underestimate at the higher TSB level. The accuracy of using TcB values to detect neonates who required phototherapy was 92.5%. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 78.3, 94.2, 62.1, and 97.3%, respectively. If TcB +3 mg/dL was applied as a cutoff point, the sensitivity, specificity, PPV, and NPV were 100, 53.9, 20.7, and 100%, respectively.Conclusions: Bilicare™ TcB and TSB measurements were well correlated. The TcB level +3 mg/dL could detect all neonates who had significant hyperbilirubinemia requiring phototherapy during their birth hospitalization.