Total Serum Bilirubin Measurements Research Articles

Duration of a standard phototherapy course in jaundiced newborns with no neurotoxicity risk.

In this study, we aimed to determine an ordinary/empiric/standard phototherapy treatment protocol for duration without controlling total serum bilirubin (TSB) levels after initiating phototherapy in early-term and full-term jaundiced newborns who had no hyperbilirubinemia neurotoxicity risk factors. We compared two groups, each receiving either 24 h (Group I) or 18 h (Group II) of continuous phototherapy in terms of demographic characteristics and efficacy (rate of decrease in TSB levels with phototherapy). No control TSB measurements were performed in the study groups until the end of phototherapy for the predetermined durations. Declines in TSB after phototherapy were significantly greater in Group I than in Group II, both in terms of mg/dl (11.81 ± 2.93 mg/dl vs. 10.75 ± 2.48 mg/dl, P = .0008) and percentage (56.71 ± 9.06% vs. 52.86 ± 8.37%, P = .0002). However, the rate of TSB reduction after phototherapy in mg/dl/h (0.59 ± 0.13 mg/dl/h vs. 0.49 ± 0.12 mg/dl/h, P = <.0001) and percentage per hour (2.93 ± 0.37% vs. 2.36 ± 0.46%, P = <.0001) were significantly higher in Group II than in Group I. This indicates an inverse time-response relationship between the duration of phototherapy and the response rate in the study groups. Although the 24-h phototherapy course showed greater efficacy concerning the primary bilirubin outcome measures (decline in TSB in mg/dl and %), the 18-h course of phototherapy treatment provided better hourly outcomes and reached its saturation point around the 18th hour. Therefore, an 18-h phototherapy without TSB monitoring until the end of the phototherapy should be considered for jaundiced newborns lacking neurotoxicity risk factors.

The Effect of Tub Bathing on the Skin and Bilirubin Levels of Babies Receiving Tunnel and Light-Emitting Diode Phototherapies: A Randomized Controlled Trial.

To investigate the effects of tub bathing on the skin and bilirubin levels of newborns receiving tunnel and light-emitting diode phototherapy. In this randomized controlled trial, hospitalized newborns diagnosed with hyperbilirubinemia treated with a tunnel or light-emitting diode device were randomly assigned to either the experimental (bath) or control (no bath) groups using a computer program. The skin integrity moisture balance of all groups was recorded using the Newborn Skin Condition Score at 6, 12, and 24 hours after phototherapy, and their total serum bilirubin measurements were evaluated. A statistically significant difference was observed in the babies' total serum bilirubin levels; this decrease was the highest in the experimental groups. Further, the skin integrity-moisture balance was higher in the experimental groups than in the control groups; it was highest in the tunnel-experimental group and lowest in the tunnel control group. These results show that bathing is effective in reducing total bilirubin levels. This study adds to the evidence on skin integrity and moisture balance in newborns who were bathed during phototherapy.

Comparative analysis of the quantitative point-of-care CareSTART™ total bilirubin with central laboratory total bilirubin assays in neonatal blood samples.

This study aimed to assess and compare the accuracy of point-of-care CareSTART™ S1 Total Bilirubin test with a central laboratory total bilirubin assay using neonatal samples. This study was conducted using 152 paired measurements obtained from 122 neonates admitted to the neonatal intensive care unit. Total serum bilirubin (TSB) levels assayed with the central laboratory assay, laboratory bilirubinomter, trancutaneous bliribubin (TcB) instrument and CareSTART were compared using Bland-Altman analysis. The mean difference between the CareSTART and TSB values was -1.43 mg/dL and the 95% limit of agreement (LoA) was -4.25 to 1.39 mg/dL. CareSTART tended to underestimate total bilirubin concentrations compared with TcB, however, the LoA was narrower due to the smaller SD of mean difference for CareSTART. The CareSTART Total Bilirubin test provides an accurate alternative to TcB for total serum bilirubin measurement. Given its low-cost, ease-of-use, and portability, the use of CareSTART is expected to provide point-of-care measurements, especially in low-resource settings.

Hyperbilirubinemia screening and treatment in neonates born prior to 35 weeks of gestation.

Guidelines on when to screen for neonatal hyperbilirubinemia apply to infants born at 35 weeks or later of gestation. It is unknown whether infants born earlier would benefit from similar guidelines. Our objective was to examine hyperbilirubinemia screening and phototherapy prescription among early preterm infants during the first 6 days of life. We reviewed the charts of 193 infants born prior to 35 weeks of gestation who were admitted to a tertiary care NICU in Southeastern Ontario in 2018-2019. Information on total serum bilirubin (TSB) measurements over each 12-hour interval during the first six days of life and the treatment decision (no treatment, initiate, continue, or stop phototherapy) was extracted. We also examined what proportion of infants were prescribed phototherapy during each 12-hour interval. Of 1006 TSB measurements performed over the first 6 days of life, 605 were done to determine whether phototherapy should be initiated. Treatment was prescribed in 275 instances (45%). A higher proportion of infants born prior to 28 weeks of gestation required phototherapy in the first 12 hours of life (37%) compared to those born at 28-32 weeks (20%) and 33-34 weeks (5.7%). Our results suggest that TSB measurements are often poorly timed to detect treatment need in infants born prior to 35 weeks of gestation. This unnecessarily increases the risk of complications from phlebotomy and is an ineffective use of health care resources. There is a need to develop guidelines to optimize hyperbilirubinemia screening among early preterm infants.

Correlation of Capillary Tube and Transcutaneous Methods with Serum Biochemistry in Bilirubin Levels in Neonates with Jaundice

Objective: The aim of this study was to compare transcutaneous bilirubin (TcB) measurement, which is a noninvasive, easy, fast and inexpensive method in the treatment of patients with neonatal jaundice, with total serum bilirubin (TSB) measurement values, which is the standard method. Simultaneous capillary tube bilirubin values were also included in the study in terms of correlation. We investigated whether it would be safe to use TcB measurement instead of blood sampling for jaundice assessment. Materials and Methods: Between January 1, 2023 and July 1, 2023, newborns with gestational jaundice aged 37-42 weeks who were hospitalized with neonatal jaundice were enrolled in the neonatal intensive care unit of Gaziosmanpaşa University Faculty of Medicine (Tokat, Turkey). Patients with confirmed neonatal jaundice were retrospectively analyzed. Patients with antenatal or postnatal disease, ABO-Rh blood group incompatibility, and preterm-post-term neonates were excluded from the study. In addition, those who received phototherapy for the first time and did not have a history of transfusion were included in the study. Results: All 72 patients were term neonates. The mean gestational age was 37.26 weeks (range, 37-40 weeks) and the mean weight was 2789 ± 15 g (2255-4550 g). Thirty-one (43.1%) of the newborns were male. The direct Coombs test was 1+ in three newborns and 4+ in one newborn. There was a strong correlation between TcB bilirubin levels and TSB values before and after treatment (r = 0.776, p &amp;lt; 0.001; r = 0.773, p &amp;lt; 0.001, respectively). A strong correlation was observed between capillary tube bilirubin and TSB measurement values before and after treatment (r = 0.875, p &amp;lt; 0.001; r = 0.899, p &amp;lt; 0.001, respectively). Conclusion: In our study, we found a strong correlation between transcutaneous bilirubin measurement, serum bilirubin and capillary tube method performed through the ear before and after phototherapy treatment. However, due to the small size of this study, we cannot recommend the use of transcutaneous measurement alone in making treatment decisions.

Bilirubin Measurement and Phototherapy Use After the AAP 2022 Newborn Hyperbilirubinemia Guideline.

Guidelines for the management of neonatal hyperbilirubinemia have helped to reduce rates of significant hyperbilirubinemia. However, recent evidence suggesting overtreatment and potential harms of phototherapy have informed the American Academy of Pediatrics clinical practice guideline revision and the accompanying increase in phototherapy thresholds. These changes are predicted to safely reduce overuse; however, to date, the exact effect of these guidelines has not been established. We conducted a retrospective study of newborns born at ≥35 weeks' gestation across a network of 8 hospitals between January 2022 and June 2023. Outcomes included rates of phototherapy and total serum bilirubin (TSB) measurements before and after guideline publication, as well as clinical outcomes, including length of stay, readmissions, and duration of phototherapy. In our cohort of >22 000 newborns, we observed a 47% decrease in phototherapy utilization, from 3.9% to 2.1% (P < .001). TSB measurements were reduced by 23%, from 712 to 551 measurements per 1000 newborns (P < .001), without an increase in outpatient TSB measurements. We did not observe an increase in readmissions receiving phototherapy, and length of stay increased by only 1 hour (P < .001). Our study reveals that the publication of the updated American Academy of Pediatrics 2022 hyperbilirubinemia guidelines has likely yielded a significant reduction in phototherapy use and serum bilirubin measurement. Dedicated quality improvement initiatives may help determine which implementation strategies are most effective. Further population-level studies are needed to confirm safety with ongoing guideline uptake.

Correlation between transcutaneous bilirubinometry and serum bilirubin in newborns ≥ 35 weeks

to determine the correlation between transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) levels in newborns ≥ 35 weeks. observational, cross-sectional, analytical, retrospective study that included 90 neonates of gestational age ≥ 35 weeks with mucocutaneous jaundice who underwent TcB and TSB measurement simultaneously between June 1, 2022, and January 31, 2023. Both variables were compared, determining their correlation. the validity indicators were analyzed, obtaining 100% sensitivity and negative predictive value. The mean of TcB determinations was 14.84 mg/dl ± 2.27 and that of TSB was 13.1 mg/dl ± 2.39. The correlation obtained indicates that both variables are related, which is a direct correlation and, according to the prediction equation, there is an appropriate correlation between them. It was determined that TcB overestimated TSB in 95.56% of the determinations, and underestimated TSB in the rest (4.44%). Simultaneous measurements of TcB and TSB were different in all determinations with a mean difference of 1.72 ± 1.48. the non-invasive TcB method can be used as an initial screening tool for the neonatal population ≥ 35 weeks, given its adequate sensitivity and negative predictive value.

Validity of BiliDx as a point-of-care bilirubin measurement device to diagnose and monitor neonatal jaundice at Muhimbili National Hospital, an observational study

BackgroundNeonatal jaundice is a condition caused by elevated levels of bilirubin in the bloodstream. Laboratory determination of serum bilirubin concentration by total serum bilirubin (TSB) test is still considered as gold standard for clinical guidance and practice. In developed countries, diagnosis of neonatal jaundice is shifting towards point-of-care medical devices. BiliDx is a device developed to allow a fast, blood-based determination of bilirubin levels at the point of care. This study aimed to determine the accuracy of the BiliDx device relative to a standard laboratory total serum bilirubin to diagnose and monitor jaundice among neonates admitted at Muhimbili National Hospital (MNH).Material and methodologyThis was a prospective hospital-based observational study conducted at the Neonatal Ward – MNH, Dar-es-Salaam, Tanzania from November 2022 to January 2023. A total of 180 neonates admitted at the neonatal ward with jaundice and whose parents consented were enrolled in the study. Blood samples were collected; 2 ml of venous blood into the vacutainer bottle for standard laboratory measurement of total serum bilirubin (TSB) and 25µL blood collected into a transfer pipette tube and applied to BiliDx. STATA version 15.1 was used for data analysis.ResultsOut of 180 neonates, 39.4% (71/180) had birth weight between 1500 − 2499.9 g, approximately 2/3rd (120/180) were preterm, 92/180 (51.1%) were males and 100/180 (55.6%) were undergoing phototherapy treatment the moment sample taken. The mean bilirubin concentration was 92 mmol/l for BiliDx and 118 mmol/l for standard laboratory TSB. The minimum and maximum values obtained with BiliDx were, 3.4 and 427.5 mmol/l respectively, compared with 10.7 and 382.1 mmol/l using standard laboratory TSB. A linear relationship and correlation coefficient of 0.8408 (p = 0.000) between BiliDx and standard laboratory TSB was found. The regression analysis showed the presence of constant error [coefficient of BiliDx/slope = 0.91, 95% CI (0.82–0.99), p = 0.000] and random error exclusively [coefficient of constant/y-intercept = 48.52, 95%CI (37.70-59.34), p = 0.000]. The Bland–Altman plot showed an acceptable mean difference of 39.1mmol/l, limits of agreement of -48.3mmol/l to 126.4mmol/l, and 179 points (179/180 = 99.4%) lying inside the limits of agreement.ConclusionThe results support the use of BiliDx for rapid and accurate testing of elevated levels of bilirubin in the bloodstream among neonates since 99.4% of the differences between BiliDx and standard laboratory TSB lie between the lines of agreement.

The Importance of Screening of Galactosemia in urine of Neonate

Objectives: Galactosemia is metabolic inborn error occurred due to deficient activity in the enzyme incorporated in the metabolism of galactose sugar. Galactosaemia is a common cause of liver metabolic disease in period of childhood, it is important cause of newborn hyperbilirubinemia therefore the study designed to illustrate the Importance of Screening of Galactosemia in urine of Neonate. Materials and Methods: the study was done on the patients those attended to the Al-Rawan specialist laboratory in Najaf between January 2023 to June 2024. Forty tow patients were incorporated into our study. Tow milliliter of urine sample was taken from each patient to use in galactosemia rapid test in urine and tow milliliter of blood sample was taken from the same patient for the measurement of total serum bilirubin. Results: Forty-two neonatal patients divided according to the results of galactosemia rapid test in urine in to tow group positive galactosemia group 31(73.8%) and negative galactosemia group 11 (26.2%). The 31 positive galactosemia patients were involved into this study ; 15 were female and 16 were male. In comparison, there were 11 female and 0 male among negative galactosemia group. Also there was a high difference in the mean level of total serum bilirubin between positive galactosemia patients and negative galactosemia patients. The high rate of positive results of galactosemia recorded in age between 1day to 3month although there were no significant differences between age groups p-value 0.22. In this study the sensitivity of the test of galctosemia in urine was 93.75% and the specificity 80%. Conclusions: Galactosemia neonatal screening may protect infants from complications cause life-threatening if detected in early stages of life.

Transcutaneous Bilirubin Accuracy Before, During, and After Phototherapy: A Meta-Analysis.

Transcutaneous bilirubinometry (TcB) is used as a valid screening to identify neonates requiring measurement of total serum bilirubin (TSB) before phototherapy. Its use during and after phototherapy is not advised yet because of unknown reliability. To determine the agreement of TcB and TSB measurements before, during, and after phototherapy. PubMed Medline, Cochrane Library, and references of eligible studies were searched. Prospective and retrospective cohort and cross-sectional studies reporting Bland-Altman statistics of paired TcB and TSB measurements in term and preterm newborns. Meta-analysis was performed using the Mantel-Haenszel weighted approach. The agreement between TcB and TSB in μmol/L was described by pooled mean differences (MDs) and limits of agreement (LoA). Fifty-four studies were included. The pooled MD before phototherapy is 2.5 μmol/L (LoA -38.3 to 43.3). The pooled MD during phototherapy is -0.3 μmol/L (LoA -34.8 to 34.2) on covered skin and -28.6 μmol/L (LoA -105.7 to 48.5) on uncovered skin. The pooled MD after phototherapy is -34.3 μmol/L (LoA -86.7 to 18.1) on covered skin and -21.1 μmol/L (LoA -88.6 to 46.4) on uncovered skin. Subgroup analysis revealed the best agreement at the forehead. We did not find any difference in agreement between term and preterm neonates. Language restriction. TcB measurements before and during phototherapy on covered skin show good agreement compared with TSB in term and preterm newborns. More studies are needed to evaluate the accuracy after phototherapy.

Comparison of Transcutaneous and Total Serum Bilirubin Measurements at Five Different Sites in Newborns before and after Phototherapy.

This study aims to examine the accuracy of transcutaneous bilirubin (TcB) in estimating the total serum bilirubin (TSB) level at five different sites before and immediately after phototherapy. This study prospectively enrolled infants with a gestational age of 34 to 416/7 weeks who were clinically diagnosed with neonatal jaundice and required phototherapy within 28 days after birth. TcB levels were measured on the uncovered four areas (forehead, mid-sternum, abdomen, and interscapular site) and covered hipbone by using the Dräger JM-103 Jaundice Meter before phototherapy and at 0 min after discontinuing phototherapy. Correlation and agreement between TcB and TSB levels were assessed before and after phototherapy. We included 108 infants with a mean gestational age of 37.6±1.5 weeks and birth weight of 3108±548 g. A strong significant correlation was found between TSB and TcB measurements at all five sites before phototherapy with the strongest correlation at the interscapular site (r=0.768, p=0.001). The correlation was weakened between TSB and TcB at all five sites after phototherapy; however, the strongest correlation was at the covered hipbone (r=0.619, p=0.001). TcB measurements at all five sites tended to underestimate TSB levels before and after phototherapy. The difference (TcB - TSB) tended to increase with increasing TSB levels. TcB levels were most accurately measured at the interscapular site and covered hipbone before and immediately after phototherapy, respectively.

The Accuracy of Transcutaneous Bilirubin as a Screening Test in Preterm Infants.

To determine the accuracy of transcutaneous bilirubin (TcB) to predict total serum bilirubin (TSB) in preterm infants across gestational age (GA) ranges and to calculate the cost-effectiveness of TcB as the primary screening test of choice for neonatal jaundice in neonatal intensive care unit (NICU) settings. Single-center retrospective study of infants aged ≤ seven days admitted to the NICU over a six-month period with a paired TSB and TcB, with or without phototherapy as part of their routine clinical care. Infants were divided into GA-specific groups asterm, late preterm, moderate preterm, and very preterm. Measurement bias (bias=TSB-TcB) was calculated on the paired TSB and TcB values, and a Bland-Altman analysis was carried out. The impacts of additional infant-specific variables on the bias were assessed with univariate and multivariate linear regression techniques. The potential direct cost savings associated with the use of TcB as the primary screening test were calculated. A total of 263 paired TSB and TcB samples from 95 patients were included (130 paired samples from term (n=60), 75 from late preterm (n=21), 27 from moderate preterm (n=7), and 31 from very preterm (n=7)). The mean paired measurement bias across all the GA groups was -0.9 ± 2.9 mg/dL. The sensitivity and specificity of TcB in GA < 35 weeks were 92% and 62%, respectively. A conservative estimate of a one-third reduction in TSB measurement by using TcB as the primary screening test will have a direct cost saving of $3,148 over a six-month period. Our data suggest that TcB is a safe and potentially cost-effective screening test for jaundice across GA groups.

Performance of smartphone application to accurately quantify hyperbilirubinemia in neonates: a systematic review with meta-analysis.

Neonatal jaundice is a common clinical condition that can progress to severe hyperbilirubinemia if identification and intervention are delayed. In this study, we aimed to analyze the current evidence on the accurate performance of smartphone applications to quantify bilirubin levels. PubMed, Embase, Emcare, MEDLINE, the Cochrane Library, and Google Scholar were searched from inception until July 2022. Grey literature was searched on "OpenGrey" and "MedNar" databases. We included prospective and retrospective cohort studies that recruited infants with a gestation of ≥ 35weeks and reported paired total serum bilirubin (TSB) and smartphone app-based bilirubin (ABB) levels. We conducted the review using the guidelines of the Cochrane Collaboration Diagnostic Test Accuracy Working Group and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-diagnostic test accuracy (PRISMA-DTA) statement. The data were pooled using the random effects model. The outcome of interest was agreement between ABB and TSB measurements, provided as correlation coefficient, mean difference, and standard deviation. Certainty of evidence (COE) was assessed based on GRADE guidelines. Fourteen studies were included in the meta-analysis. The number of infants in individual studies ranged between 35 and 530. The pooled correlation coefficient (r) between ABB and TSB was 0.77 (95% CI 0.69 to 0.83; p < 0.01). Reported sensitivities for predicting a TSB of 250µmol/L in individual studies ranged between 75 and 100% and specificities ranged from 61 to 100%. Similarly, a sensitivity of 83 to 100% and a specificity of 19.5 to 76% were reported for predicting a TSB of 205μmol/L. Overall COE was considered moderate. Conclusion: Smartphone app-based bilirubin estimation showed a reasonable correlation to TSB levels. Well-designed studies are required to determine its utility as a screening tool for various TSB cut-off levels. What is Known: • Neonatal jaundice is a common clinical condition.Timely screening and intervention are necessary to prevent neurological morbidities • Transcutaneous bilirubinometer is a widely used non-invasive screening device but is mostly available in hospital settings and has cost limitations.Researchers have recently explored the utility of smartphone applications to estimate bilirubin levels in neonates. What is New: • This is the first systematic review and meta-analysis conducted to assess the performance of smartphone applications to detect neonatal hyperbilirubinemia. • Bilirubin estimates of newborn infants obtained through smartphone applications had a reasonable correlation with serum bilirubin levels.

Evaluate of newborn with jaundice at central teaching hospital of pediatrics in Baghdad : descriptive study

Background: - Neonatal jaundice is a frequent condition at newborns, particularly in the first few days after delivery, and it has to be treated well to prevent complications that might have significant, long-lasting complications.&#x0D; Objective: - To assess the outcome of newborn jaundice at the central teaching Hospital of pediatrics in Baghdad using different modality of treatments.&#x0D; Patients and Methods: - A retrospective study is done depending on the medical data of infants have jaundice who were admitted to the neonate units of the central teaching hospital within the period of a year, from May 1st 2020 to May 1st 2021. Blood grouping and total serum bilirubin measurements were taken in each case. Phototherapy, strong phototherapy, and exchange transfusion were utilized to treat the newborn jaundice, depending on its severity.&#x0D; Results: Total neonates admitted from 1st may2020 to1st may 2021 in neonate unit were 2508 and 855 [34%] have jaundice. the male: female rati0 is [1.6:1], males 516[60.3%], females 339[39.6%]. The Physiol0gical jaundice is the often-frequent cause 285[33.3%] patients. The Prematurity seen in 171[20%] patient and the ABO incompatibility seen in 128[1.3%] and the Rh incompatibility 17[2%] patient, the sepsis found in 16[2%] case and the other causes of hyperbilirubinemia seen in 238[27.8%] patient. the Phototherapy is the most frequent kind of management used in 513[55%] and intensive phototherapy is applied for 342[40.3%] patients and just 59[7%] of patients treated with exchange transfusion particularly patients with ABO incompatibility 25 [42%] also Rh incompatibility 34 [57.6%] Good decline in TSB level and not require the exchange transfusion is 812 [95%] of patients. Majority of infants 849 [99.55%] discharge with clinical improvement and only 17 [0.3%] of infant’s patients develops kernicterus and 8 patients is dying [0.1%]&#x0D; Conclusion: Moderate to severe hyperbilirubinemia is still often treated with phototherapy. Intensive phototherapy is beneficial in lowering T.S.B levels, minimizing the need for exchange transfusions, and shortening hospital stays in patients with newborn hyperbilirubinemia.

Decreasing Bilirubin Serum Tests in Healthy Newborns During Birth Hospitalization.

Substantial variability exists in hyperbilirubinemia screening and monitoring leading to unnecessary total serum bilirubin (TSB) testing in healthy newborns. We aimed to assess the impact of value-care interventions to decrease the monthly TSB testing rate per 100 patient-days among healthy newborns in our Mother-Baby Unit by 30% by June 2022. We formed a multidisciplinary team to review the current practice for ordering TSB among housestaff in our Mother-Baby Unit. We identified several themes: variation in clinical practice, fear of hyperbilirubinemia, and desire to act for high-intermediate risk bilirubin levels. The interventions consisted of obtaining faculty buy-in, redesigning the hyperbilirubinemia pathway, educating staff on high value-care, producing an instructional video, and prompting staff to incorporate a bilirubin risk assessment via smart phrases in our electronic health record. The primary outcome was the monthly TSB testing rate per 100 patient-days. Universal predischarge bilirubin screening, length of stay, phototherapy rates, and readmission rates were chosen as balancing measures. The monthly rate of TSB testing was reduced from 51 to 26.3 TSB per 100 patient-days, representing a 48% reduction. This improvement was sustained for 12 months. The percentage of infants with at least 1 TSB measurement during birth hospitalization decreased from 48% to 30%. Predischarge bilirubin screening, length of stay, and readmission rates were unchanged. Our quality improvement initiative led to a significant reduction in the monthly TSB testing per 100 patient-days in healthy newborns without evidence of harm.

Transcutaneous bilirubinometry versus total serum bilirubin measurement for newborns.

Jaundice is a very common condition in newborns, affecting up to 60% of term newborns and 80% of preterm newborns in the first week of life. Jaundice is caused by increased bilirubin in the blood from the breakdown of red blood cells. The gold standard for measuring bilirubin levels is obtaining a blood sample and processing it in a laboratory. However, noninvasive transcutaneous bilirubin (TcB) measurement devices are widely available and used in many settings to estimate total serum bilirubin (TSB) levels. To determine the diagnostic accuracy of transcutaneous bilirubin measurementfor detecting hyperbilirubinaemia in newborns. We searched CENTRAL, MEDLINE, Embase, CINAHL and trial registries up to 18 August 2022. We also checked the reference lists of all included studies and relevant systematic reviews for other potentially eligible studies. We included cross-sectional and prospective cohort studies that evaluated the accuracy of any TcB device compared to TSB measurement in term or preterm newborn infants (0 to 28 days postnatal age). All included studies provided sufficient data and information to create a 2 × 2 table for the calculation of measures of diagnostic accuracy, including sensitivities and specificities. We excluded studies that only reported correlation coefficients. Two review authors independently applied the eligibility criteria to all citations from the search and extracted data from the included studies using a standard data extraction form. We summarised the available results narratively and, where possible, we combined study data in a meta-analysis. We included 23 studies, involving 5058 participants. All studies had low risk of bias as measured by the QUADAS 2 tool. The studies were conducted in different countries and settings, included newborns of different gestational and postnatal ages, compared various TcB devices (including the JM 101, JM 102, JM 103, BiliChek, Bilitest and JH20-1C) and used different cutoff values for a positive result. In most studies, the TcB measurement was taken from the forehead, sternum, or both. The sensitivity of various TcB cutoff values to detect significant hyperbilirubinaemia ranged from 74% to 100%, and specificity ranged from 18% to 89%. The high sensitivity of TcB to detect hyperbilirubinaemia suggests that TcB devices are reliable screening tests for ruling out hyperbilirubinaemia in newborn infants. Positive test results would require confirmation through serum bilirubin measurement.

Accuracy of transcutaneous bilirubin level measured by a JM-105 bilirubinometer.

Transcutaneous bilirubin (TcB) measurement is useful, but dissociation with total serum bilirubin (TSB) is a clinical problem in measurement. We verified the accuracy of the latest version of the JM-105 jaundice meter. The TcB, TSB, and hematocrit (Hct) measurements obtained in the first 4 days of life in 2788 term neonates were analyzed. When divided into 2-mg/dL classes, the difference between the TcB and TSB measurements did not change as TcB increased, but both overestimation and underestimation of TcB increased as TcB increased. At TcB greater than 11mg/dL, inaccurate measurements with dissociation greater than 2mg/dL exceeded 10% of the TcB measurements. The Hct value was associated with overestimation and underestimation. To evaluate neonatal jaundice accurately, it is desirable to measure TSB by blood sampling before discharge from obstetrics or in the case of worsening jaundice on day 4 or 5 of life.

Bilirubin Measurement Through a Smartphone Application in Preterm Infants.

Aim of the present study is to evaluate the feasibility and reliability of an smartphone application for monitore of bilirubin levels in preterm infants. Preterm infants hospitalized in the neonatal intensive care unit with gestational age of<35 weeks were included. Exclusion criteria were parental reluctance and requirement of phototherapy in the last 12 hours. Measurements were obtained through a smartphone application (BiliScan) along with simultaneous transcutaneous device (Dräger JM 105) and venous blood biochemistry. Mean gestational age was 30.8±2.4 weeks and birth weight was 1622±566 g. Measurements were obtained at a median of 4 (1-21) days of life. Twenty-five infants (19.4%) had ABO and/or Rh incompatibility and 39 infants (30.2%) required phototherapy. None of the cases required exchange transfusion. Mean total serum bilirubin (TSB) level was 8.16±2.60 mg/dL, mean transcutaneous bilirubin (TcB) level was 8.60±2.70 mg/dL, and the mean bilirubin level measured by BiliScan was 7.26±2.68 mg/dL. For TSB and TcB measurements, the intraclass correlation coefficient (ICC) was found to be 0.915 (95% confidence interval 0.835-0.951; p<0.001) and a strong positive correlation was found between these two measurements. When TSB and BiliScan measurements were compared, ICC was found to be significant as 0.512 (95% confidence interval 0.353-0.638; p<0.001), with a moderate correlation. In this study, we evaluated the feasibility and reliability of a smartphone application for monitoring bilirubin levels in preterm infants. Although BiliScan measurements reported to display high correlation in term infants, a moderate correlation was found in the preterm infants. It is an emerging low-cost, non-invasive alternative for neonatal jaundice monitoring, however, results should be interpreted with caution in preterm infants.

Intérêt de la bilirubinémie en néonatalogie : recommandations pour une utilisation coordonnée par le LBM de la biologie délocalisée et des tests rapides d’orientation diagnostique

In pediatrics, accurate measurement of total serum bilirubin (TSB) is of major importance for reliable diagnosis and appropriate management of neonatal jaundice. However, several studies evidenced poor comparability of results obtained with the different available methods either in central lab or in POCT, on serum, capillary blood or transcutaneous. This situation is partly due to the lack of Reference Materials, especially for high bilirubin concentrations but also on poor communication between central lab and neonatology unit. To progress on these issues, we have compiled some data from CNRHP to propose guidelines for choice, use and management of POCT devices and to help clinical laboratories to achieve a better answer to clinical needs with specific local constraints. The results from several CNRHP studies are presented: traceability to International System of Units, inter-laboratories comparability, POCT vs central labs comparisons with POCT CO-oximeter or photometer, integration of transcutaneous bilirubinometer. We propose, based on an analysis of devices advantages and issues, guidelines to help labs either to improve neonates monitoring in their local context; we distinguished the choices inside laboratory for a better harmonization of results compared to published thresholds and outside lab contexts, to organize a coordinated chain with POCT devices, with capillary and/or transcutaneous approaches.

Refining interpretation of transcutaneous bilirubin measurement in newborns born late preterm.

Transcutaneous bilirubin (TCB) monitoring is widely used for jaundice screening in the newborn period. Limited data exists on adjusting TCB for bias in late preterm infants. The objective of this study was to determine the median bias between transcutaneous bilirubin and total serum bilirubin levels in newborns born at 35-36 weeks' gestation. This was a retrospective cohort study of late preterm infants born at 35-0/7 to 36-6/7 weeks' gestation who were admitted to a level III neonatal intensive care unit from May 2018 to February 2020. Transcutaneous and total serum bilirubin levels were assessed within 2h of each other during the first 60h of life. Bland-Altman plots were used to evaluate transcutaneous bilirubin bias. Bilirubin risk stratification based on age (in hours) was done using an adaptation of the Bhutani nomogram for transcutaneous, adjusted transcutaneous, and total serum bilirubin measurements. The median bias between transcutaneous and total serum bilirubin bias was 2.4mg/dL (IQR 1.7-3.4, 95% CI 2.2-2.7). The kappa statistic demonstrated slight agreement between the unadjusted transcutaneous bilirubin and total serum bilirubin (k=0.033, p=0.194. The kappa statistic demonstrated fair agreement between an adjusted transcutaneous bilirubin (subtract 1mg/dL) and total serum bilirubin (k=0.298, p<0.0001) and moderate agreement between another adjusted transcutaneous bilirubin (subtract 2mg/dL) and total serum bilirubin (k=0.430, p<0.0001). In a single center study of late preterm infants, transcutaneous bilirubin systematically overestimated the total serum bilirubin level. Subtracting 1mg/dL from the transcutaneous bilirubin identified infants with total serum bilirubin levels in the high or high intermediate risk range. Adjusting the transcutaneous bilirubin prior to risk stratification may reduce unnecessary blood draws for total serum bilirubin. Studies of racially and ethnically diverse newborns using various transcutaneous bilirubin meters are needed prior to broad application of the adjusted transcutaneous bilirubin approach.