Transcutaneous Bilirubin Levels Research Articles

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.

An End-Tidal Carbon Monoxide Nomogram for Term and Late-Preterm Chinese Newborns

To establish a reference nomogram for end-tidal CO corrected for ambient CO (ETCOc) levels in term and late-preterm Chinese newborns and then assess its efficacy to identify hemolytic hyperbilirubinemia. We conducted a prospective study by measuring concurrent ETCOc and total serum bilirubin (TSB) or transcutaneous bilirubin (TcB) levels collected postnatally at 12, 24, 48, 72, 96, and 120hours of age. ETCOc at the 25th, 50th, 75th, and 95th percentiles at each epoch were used to construct the reference nomogram. We then explored the ability of predischarge ETCOc and TSB/TcB metrics to predict the development of hyperbilirubinemia requiring phototherapy in early postnatal period and jaundice readmission in late postnatal period. Our nomogram, based on 990 measurements from 455 infants who were not nonhemolytic, displayed a steady line within 3 postnatal days, followed by a subsequent decline. From a cohort of infants with a serial ETCOc measurements (n=130) and those readmitted (n=21), we found that ETCOc and TSB/TcB ≥75th percentile can identify most hemolytic hyperbilirubinemia between 12 and 72hours after birth with an area under the curve (AUC) of 0.741. An ETCOc ≥1.7ppm alone between 96 and 120hours after birth can identify most hemolytic hyperbilirubinemia with an AUC of 0.816. In addition, 90.5% of readmitted infants had an ETCOc ≥75th percentile. An ETCOc reference nomogram during the first 5 postnatal days in nonhemolytic term and late-preterm newborns can be used to identify hemolytic hyperbilirubinemia requiring phototherapy in the early postnatal period and readmission in the late postnatal period.

Optimal Evaluation for DAT-Positive Newborns Remains Elusive

Source: Papacostas MF, Robertson DW, McLean MD, et al. Sixth-hour transcutaneous bilirubin and need for phototherapy in DAT positive newborns. Pediatrics. 2022;149(3):e2021054071; doi:10.1542/peds.2021-054071Investigators from Naval Medical Center Portsmouth (NMCP), Portsmouth, VA, and the University of Pittsburgh School of Medicine, Pittsburgh, PA, conducted a retrospective study to assess the utility of a transcutaneous bilirubin (TcB) measurement at 6 hours of age in predicting the need for phototherapy at ≤24 hours of age in newborns with ABO incompatibility. Data on neonates born at NMCP between May 2013 and March 2017 who were ≥35 weeks’ gestation were reviewed. Infants were classified as having ABO incompatibility if born to mothers with type O blood and negative antibody screens and themselves had type A or B blood with positive direct antiglobulin tests (DAT).At NMCP, blood is obtained from newborns with ABO incompatibility at 6 hours of age for total serum bilirubin (TSB), hemoglobin, hematocrit, and reticulocyte counts; providers are encouraged to also obtain a TcB measurement. Infants with paired blood test and TcB results were included in study analyses; demographic and clinical data were abstracted from the medical records of these newborns. The primary study outcome was need for phototherapy at ≤24 hours of age, as determined by the attending pediatrician. Demographic and clinical characteristics associated with this outcome in univariate analyses were included in 2 logistic models; 1 with blood test results and no TcB levels, and the other with TcB results and no blood test data. Receiver operator characteristic (ROC) curves were constructed and the area under the curve (AUC) calculated. The positive and negative predictive values (PPV and NPV, respectively) of different TcB cutoff values in predicting the need for phototherapy at ≤24 hours also were determined.Among 10,942 newborns born at ≥35 weeks’ gestation, 5,167 (47.2%) were born to mothers with type O blood, DAT was positive in 829 (7.6%), and 772 (7.1%) infants met criteria for ABO incompatibility. A total of 346 newborns had paired blood test and TcB results, 21% of whom were treated with phototherapy at ≤24 hours of age. In univariate analyses, birth weight, type B blood, TSB level, reticulocyte count, and TcB were significantly associated with the need for phototherapy at ≤24 hours. In the multivariate model that excluded TcB results, only TSB and reticulocyte counts were independently associated with the outcome (odds ratio [OR], 12.6; 95% CI, 6.1, 25.6; and OR, 1.5; 95% CI, 1.0, 2.1, respectively). In the other model, TcB was significantly associated with the need for phototherapy at ≤24 hours of age (OR, 3.1; 95% CI, 2.4, 4.0). The ROC AUCs were similar for the 2 models (0.96 and 0.90, respectively). A TcB value of ≤3.0 mg/dL yielded a NPV of 98%, a value of ≥5.3 mg/dL, and a PPV of 85% for predicting the need for phototherapy at ≤24 hours of age.The authors conclude that a 6-hour TcB level was predictive of the need for phototherapy at ≤24 hours of life in newborns with ABO incompatibility.Dr Von Kohorn has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.The most recent (although outdated) AAP clinical practice guidance advises universal pre-discharge assessment of bilirubin level in newborns, with treatment based on risk stratification combining bilirubin level and risk factors.1,2 Isoimmune hemolytic disease is a risk factor both for severe hyperbilirubinemia and neurotoxicity.2 Although recent evidence about the risks of phototherapy has called universal screening into question, close monitoring of infants with risk factors remains a priority.3,4The current investigators demonstrate that 6-hour blood and TcB tests predict the need for phototherapy at or before 24 hours of life. The investigators do not describe the trend in phototherapy use. They suggest using TcB values that correspond to 98% NPV and 85% PPV to guide clinical practice at 6 hours of life. Importantly, the study does not indicate whether 6-hour testing or the proposed TcB values reduce key outcomes such as severe hyperbilirubinemia, bilirubin encephalopathy, hospital readmission, or cost. The authors report that significantly more infants who received TcB measurements were admitted to the NICU compared to those who received only blood tests, but they do not comment on the explanations for this finding that implies possible overtreatment. In a web comment on the original article by Papacostas, Mazar astutely states that phototherapy should be started at currently recommended thresholds, regardless of projected risk.5 The authors’ reply states “it would be beneficial to identify [infants projected to need phototherapy] and start treatment earlier.” Evidence for such benefit is not presented.Six-hour bilirubin testing predicts phototherapy at ≤24 hours of life, with TcB performing nearly as well as TSB plus reticulocyte count. The relationship of 6-hour testing to clinical outcomes remains unknown.

COMPARISON OF TOTAL SERUM BILIRUBIN AND TRANSCUTANEOUS BILIRUBIN IN NEONATES WITH HYPERBILIRUBINAEMIA

Background: Jaundice is considered as one of the most prevalent and common clinical problems during neonatal period which may require interventional treatment. Transcutaneous bilirubinometry is a simple method for estimating bilirubin levels and diagnosing jaundice in neonates. This study was done to compare transcutaneous bilirubin and total serum bilirubin in jaundiced neonates. Methods: A hospital based prospective cross-sectional study of neonates from Out Patient Department, Emergency Ward, and Neonatal Intensive Care Unit with clinical jaundice was conducted between January 2016 and December 2016, at Kanti Children’s Hospital, Maharajgunj, Nepal. A total of 162 neonates were interviewed using preformed questionnaires. Then the correlation between the transcutaneous bilirubin and plasma bilirubin level was assessed by linear regression analysis. It was then analyzed with the help of SPSS Version 20. p-value &lt;0.05 was considered statistically significant. Results: Out of 162 cases, 61.7% were males and 38.3% were females. There was a high correlation between TcB and TSB level in neonates (r = 0.981) and this finding was statistically significant (p-value&lt;0.001). Correlation coefficient of 0.98 and 0.97 were found in term and preterm neonates respectively, which suggested strong correlation between TcB and TSB in both groups of neonates. Conclusions: Transcutaneous bilirubin measurement can be considered as a suitable tool for predicting neonatal bilirubinemia as it has high sensitivity.

Roles of Probiotics in Reduction of Neonatal Jaundice in Term Newborns.

the primary objective was to examine the effect of Bifidobacterium on decreasing the bilirubin level in term neonates delivered by Caesarean Section (CS). A total of 153 healthy term neonates delivered by CS were included in this study and were divided into the non-probiotic group (n=99) and probiotic group (n=54) based on the history of probiotics administration. There were no infants who underwent phototherapy. A total of 20 doses of probiotics were given orally from the first day of life. The transcutaneous bilirubin (TcB) levels were measured every day for the first 5 days of life. Data of each infant and mother were gathered from medical records. The bilirubin level per day (day-1 to day-5) in the non-probiotic group was no different from the probiotic group. Differences in bilirubin level between day-5 and day-1, and also between day-5 and day-2 were not different between the two groups. There was a significant (p = 0.03) body weight gain in the probiotic groups with a mean of 36.09 ± 8.23 gram/day. No obvious adverse reactions were seen in both the non-probiotic group and probiotic group. Our findings suggest no significant effects of probiotics on lowering bilirubin levels in the first five days of life. Also, probiotics have a positive effect on body weight gain in healthy term infants, and it is safe to be given to newborns.

THE PREVALENCE AND RISK FACTORS FOR HYPERBILIRUBINEMIA IN NEONATES

Background: Jaundice is very common in the neonatal period of life especially hyperbilirubinemia&gt;12 mg/dl. Although it is not a major cause of mortality, it is an important cause of morbidity. So, assessment of the prevalence and risk factors of neonatal jaundice is very important. Objectives: The objectives of the study were to estimate the prevalence,to identify the risk factors and to findout the association between hyperbilirubinemia with selected neonatal,maternal,environmental and socio demographic variablesand to identify the risk factors. Methodology: This descriptive cross sectional survey study was conducted among 200 neonates of 37 completed weeks of gestation. Subjects were selected by using total enumerative sampling.Transcutaneous bilirubin was measured by bilirubinometer,clinical and demographic variables collected by using semi structured questionnaire and the risk factors were assessed by interview schedule. Results:Research showed that most of neonates (81.5%) had Transcutaneous bilirubin level more than 12mg/dl, out of that (15% )subjects had elevated level of bilirubin 15- 20mg/dl. It is concluded that there is high prevalence of hyperbilirubinemia among neonates . It is evident that neonates developed hyperbilirubinemia by 48 to 72 hours. It is inferred that prevalence of hyperbilirubinemia was high at 72 hours (56.5%) after birth compared to 48 hours of birth (38%). There was a significant association between level of hyperbilirubinemia and family history of genetic diseases (P=0.003),parity (p=0.03, χ2=4.37),mode of conception(p=0.012, χ2=6.37), and gestational age(P=0.04),gender of the neonate (p=0.004, χ2=8.1)and duration of second stage of labour (p=0.026, χ2=7.27). The study revealed that the family history of genetic diseases (p=0.004),(OR=0.09) at level of significance 0.05,is a risk factor leads to hyperbilirubinemia. Conclusion: Neonatal jaundice is a leading cause of hospitalisation in the first few weeks of life throughout the world.Though major complications may arise like kernicterus,encephalopathy and neural sequlae.Hence there is an exigent need for assessing the bilirubin value in the routine neonatal assessment.

A Comparison Between Transcutaneous Bilirubin and Total Serum Bilirubin Levels for the Management of Jaundice in Preterm Neonates by Bland-Altman Plot.

ObjectiveTo compare the bilirubin levels measured by transcutaneous bilirubinometer and serum samples for the management of jaundice in preterm neonates.MethodsThe study was a prospective comparative observational study conducted in a tertiary care neonatal unit of Odisha from January 2019 to June 2020. All inborn and outborn neonates with a gestational age of 280/7 weeks to 366/7 weeks with the clinical diagnosis of neonatal jaundice were included in the study. Transcutaneous bilirubin (TcB) was estimated by Dragger jaundice meter JM-105 and simultaneously venous blood and total serum bilirubin levels (TSB) were measured by diazonium method. The comparison between TcB and TSB values was analyzed by direct linear correlation in scatter plot and Bland-Altman plot.ResultsA total of 167 preterm neonates (66, 28-336/7 and 111, 34-366/7), with a mean gestational age 33.55 ±2.36 weeks and a mean birth weight of 1960 ± 613 grams, were analyzed. The mean TSB and TcB levels were 12.99 ± 3.47 mg/dl (min-max 4.9-18.3 mg/dl) and 14.156 ± 4.71 mg/dl (min-max 4-20.1 mg/dL), respectively. The TcB is excellently correlated with TSB with a correlation coefficient of r =0.948, p ≤0.001. The bias difference between TcB and TSB is -1.16 (95% CI: 2.35, -4.6) mg/dl. The correlation coefficients between 28-336/7 weeks gestational age groups (r = 0.944) and 34-366/7gestational age (r = 0.950) were similar.ConclusionTcB is well correlated with TSB level in preterm neonates. Hence, TcB can be used for the guidance of management in these neonates.

Effects of a breastfeeding coaching program on growth and neonatal jaundice in late preterm infants in South Korea.

PurposeThis study examined the effects of a breastfeeding coaching program for mothers on growth and neonatal jaundice in late preterm infants (LPIs).MethodsThis was a quasi-experimental study (non-randomized intervention) with a time-series design. The study was conducted among 40 LPIs who were admitted to the neonatal intensive care unit of a university hospital in Daegu, South Korea. In the order of admission, the first 21 infants were assigned to the experimental group, and 19 were assigned to the control group. The intervention program consisted of home- based and web-based practical breastfeeding support education for mothers across a total of 5 sessions. Infant growth was measured using body weight, length, and head circumference, and neonatal jaundice was assessed using transcutaneous bilirubin levels.ResultsThe likelihood of breastfeeding for infants in the experimental group at 4 weeks after discharge was the same as on the day of discharge, whereas it steadily decreased in the control group. There were significant differences in head circumference between the groups. However, weight, length, and transcutaneous bilirubin levels did not show a significant group-time interaction.ConclusionA formal breastfeeding coaching program should be considered in clinical settings and at home within the first few weeks postpartum.

The Impact of Phototherapy on the Accuracy of Transcutaneous Bilirubin Measurements in Neonates: Optimal Measurement Site and Timing

Transcutaneous bilirubinometer devices are widely applied to assess neonatal hyperbilirubinemia. However, the optimal skin site and timing of transcutaneous bilirubin (TCB) measurements for the strongest correlation with total serum bilirubin (TSB) levels after phototherapy are still unclear. We conducted a retrospective observational study evaluating the correlation of TCB and TSB levels in neonates postphototherapy. The TCB measurements on the forehead and mid-sternum at 0 and 30 min postphototherapy were assessed by using a JM-103 bilirubinometer. Paired TCB and TSB measurements were assessed by Pearson correlation and Bland–Altman plots. We analyzed 40 neonates with 96 TSB and 384 TCB measurements. The TSB level correlated moderately with the forehead TCB level at 30 min postphototherapy (r = 0.65) and less strongly with the midsternum TCB level at 0 min postphototherapy (r = 0.52). The forehead at 30 min after cessation of phototherapy was the best time point and location of TCB measurement for the assessment of neonatal jaundice status. The reliability of TCB measurements varied across skin sites and durations after phototherapy. The effectiveness of TCB measurement to assess neonatal hyperbilirubinemia is much better on covered skin areas (foreheads) 30 min postphototherapy. The appropriate application of transcutaneous bilirubinometers could aid in clinical practice and avoid unnecessary management.

Bilirubin monitoring – future prospects

Monitoring of bilirubin concentration is essential during early neonatal life. According to the American Academy of Pediatrics Clinical Practice Guideline, the total serum bilirubin or transcutaneous bilirubin level should be measured in each infant in the first 24 hours of life. The concentration of bilirubin has been measured for 150 years. During that time the analytical methods for its determination have been significantly improved, the nomenclature of bilirubin has been also unified, but it is still unknown what concentration of bilirubin cause a life-threatening encephalopathy in the newborn. Under the current recommendations, clinical decisions to introduce phototherapy in the treatment of newborns’ hyperbilirubinemia are based on total bilirubin concentration, which is determined on biochemical analyzers and point of care testing systems. However, it is not always possible to predict encephalopathy based on the total bilirubin level. Probably in the future, as the availability of routine methods for the determination of unconjugated, free bilirubin becomes more available, measurement of “free” bilirubin will improve risk assessment for bilirubin neurotoxicity.

Effects of delayed cord clamping on neonatal hyperbilirubinemia in pre-gestational diabetes at term

Objective To evaluate the effects of delayed cord clamping on neonatal hyperbilirubinemia in infants born to patients diagnosed with pre-gestational diabetes (type I or type II). Methods In January 2016, our institution implemented an organization-wide thirty-second delayed cord clamping protocol. This retrospective cross-sectional study represents infants of mothers diagnosed with pre-gestational diabetes who delivered before and after protocol implementation. The study period was from October 2014 to August 2017. The primary outcome was peak neonatal transcutaneous bilirubin (mg/dL) level during neonatal hospital stay. The secondary outcomes included neonatal serum bilirubin (mg/dL), jaundice requiring phototherapy, hypoglycemia, polycythemia, respiratory distress, and neonatal intensive care unit (NICU) admission. A subgroup analysis for outcomes stratified by type of pre-gestational diabetes was also performed. Results 145 patients were included in the final analysis. The mean peak neonatal transcutaneous bilirubin level was 10.1 mg/dL ± 3.4 mg/dL for immediate cord clamping and 9.5 mg/dL ± 3.4 mg/dL for delayed cord clamping (p = .25). There were no significant differences between groups for neonatal jaundice requiring phototherapy, hypoglycemia, polycythemia, respiratory distress, or NICU admission. No differences were observed in neonatal outcome by subgroup analysis of pre-gestational diabetes type. Conclusion In our study, there was no significant increase in peak neonatal transcutaneous bilirubin in term (≥37 week) infants of mothers with pre-gestational diabetes after undergoing thirty-seconds of delayed cord clamping. In the absence of contraindications, we advocate for continued use of delayed cord clamping for these infants.

Comparing JM-105 and MBJ-20 Transcutaneous Bilirubinometers According to the Area Tested in Ethnically Diverse Late-Preterm and Term Neonates

This study aims to evaluate the correlation between the results of transcutaneous bilirubin (TcB) levels measured by the 2 transcutaneous bilirubinometers according to the area tested and to compare the TcB measurements and the serum bilirubin (SBR) levels. We screened 78 neonates born at more than 35 weeks of gestation and aged less than 168 hours for jaundice. We used JM-105 and MBJ-20 to measure the TcB at the forehead and the chest. For newborns who had high TcB measurements, we obtained blood samples during the subsequent 30 minutes. There was a strong correlation between the TcB measurements by JM-105 and MBJ-20 and this correlation was stronger when they were used on the sternum. The mean differences between the TcB measurements on the forehead and the sternum and the SBR levels were similar for the JM-105 and the MBJ-20. There was a strong correlation between SBR and the measurements using the 2 devices on the sternum (JM-105: r = 0.805; MBJ-20: r = 0.801), unlike measurements taken on the forehead by each device (r = 0.777 and r = 0.751, respectively). Both devices had high sensitivity and negative predictive values at SBR level of less than 230 μmol/L (<13.4 mg/dL) and high specificity and positive predictive values at SBR level of 230 μmol/L and greater (>13.4mg/dL). Both devices equally overestimated the actual SBR and had more reliable results if used on the sternum.

Transcutaneous versus Total Serum Bilirubin Measurements in Preterm Infants

Introduction: Transcutaneous bilirubin (TcB) measurement offers a noninvasive approach for bilirubin screening; however, its accuracy in preterm infants is unclear. This study determined the agreement between TcB and total serum bilirubin (TSB) among preterm infants. Methods: A multisite prospective cohort study was conducted at 3 NICUs in Ontario, Canada, September 2016 to June 2018. Among 296 preterm infants born at 24^0/7 to 35^6/7 weeks, 856 TcB levels were taken at the forehead, sternum, and before and after the initiation of phototherapy with TSB measurements. Bland-Altman plots and 95% limits of agreement (LOA) expressed agreement between TcB and TSB. Results: The overall mean TcB-TSB difference was −24.5 μmol/L (95% LOA −103.3 to 54.3), 1.6 μmol/L (95% LOA −73.4 to 76.5) before phototherapy, and −31.1 μmol/L (95% LOA −105.5 to 43.4) after the initiation of phototherapy. The overall mean TcB-TSB difference was −15.2 μmol/L (95% LOA −86.8 to 56.3) at the forehead and −24.4 μmol/L (95% LOA −112.9 to 64.0) at the sternum. The mean TcB-TSB difference was −31.4 μmol/L (95% LOA −95.3 to 32.4) among infants born 24–28 weeks, −25.5 μmol/L (95% LOA −102.7 to 51.8) at 29–32 weeks, and −15.9 μmol/L (95% LOA −107.4 to 75.6) at 33–35 weeks. Measures did not differ by maternal ethnicity. Conclusion: Among preterm infants, TcB may offer a noninvasive, immediate approach to screening for hyperbilirubinemia with more careful use in preterm infants born at <33 weeks’ gestation, as TcB approaches treatment thresholds. Its underestimation of TSB after the initiation of phototherapy warrants the use of TSB for clinical decision-making after the initiation of phototherapy.

Effects of delayed cord clamping on neonatal jaundice, phototherapy and early hematological status in term cesarean section

BackgroundDelayed cord clamping in full-term neonates is widely recommended, while in practice, it is rarely implemented in cesarean section due to the fear of neonatal jaundice and excessive maternal blood loss. The optimal timing of cord clamping remains uncertain. This study was to fully evaluate the effects of delayed cord clamping on short-term hematological status and jaundice in term neonates delivered by cesarean section.MethodsThis retrospective study enrolled 796 women, who were allocated into the early cord clamping group (n = 377) and the delayed cord clamping group (n = 419). The latter group was further divided into two subgroups (30–60 s, 61–120 s).The outcomes were neonatal transcutaneous bilirubin levels on 0 to 5 days of life and the rate of phototherapy. For neonates who had blood tests on the first three days of life, their hemoglobin and hematocrit were compared among groups.ResultsCompared with the early cord clamping group, delayed cord clamping merely increased the transcutaneous bilirubin level of neonates on the day of birth rather than that on the following five days. The heel peripheral blood sample size of 1–3 days in the early cord clamping group was 61, 25 and 33, and in the delayed cord clamping group was 53, 46 and 32, respectively. Delayed cord clamping at 30–60 s resulted in the higher neonatal hemoglobin level on day 3 and an increased rate of neonatal polycythemia, without a higher rate of phototherapy. Delayed cord clamping beyond 60 s did not further improve hematological status in term neonates born by cesarean section.ConclusionIn cesarean section, delayed cord clamping for 30–60 s improved the early hematological status of term neonates without the enhanced requirement of phototherapy for neonatal jaundice.

Phototherapy Using a Light-Emitting Fabric (BUBOLight) Device in the Treatment of Newborn Jaundice: Protocol for an Interventional Feasibility and Safety Study.

BackgroundNeonatal jaundice is a common condition occurring in 60%-80% of all healthy-term and late-preterm neonates. In the majority of cases, neonatal jaundice resolves spontaneously and causes no harm; however, in some neonates, significant hyperbilirubinemia can develop and lead to kernicterus jaundice, a serious neurological disease. Phototherapy (PT) is the preferred treatment for jaundice; however, to be effective, PT devices need to have a broad light emission surface to generate no or little heat and to provide an optimal wavelength and light intensity (420-490 nm and ≥30 µW/cm²/nm, respectively).ObjectiveThis study aimed to investigate the feasibility, safety, and level of satisfaction of parents and health care teams with the BUBOlight device, an innovative alternative to conventional hospital PT, in which luminous textiles have been incorporated in a sleeping bag.MethodsThis interventional, exploratory, simple group, nonrandomized, single-center trial will be conducted at Lille Hospital. In total, 10-15 neonates and their parents will be included to obtain evaluable data from 10 parent-neonate pairs. Neonates weighing more than 2500 g at birth and born with ≥37 weeks of amenorrhea that required PT in accordance with the guidelines of the National Institute For Health and Clinical Excellence will receive one 4-hour session of illumination. Total serum bilirubin and transcutaneous bilirubin levels were obtained at the start and 2 hours after the end of PT. Cutaneous and rectal temperatures, heart rate, and oxygen saturation will be measured at the beginning and during PT. The number of subjects is therefore not calculated on the basis of statistical assumptions. We aim to obtain a minimum proportion of 90% (ie, 9 of 10) of the neonates included, who have been able to undergo 4-hour PT without unacceptable and unexpected toxicities. We will calculate the mean, median, quartiles, minimum and maximum values of the quantitative parameters, and the frequency of the qualitative parameters. The rate of patients with no unacceptable and unexpected toxicities (ie, the primary endpoint) will be calculated.ResultsThe first patient is expected to be enrolled at the end of 2020, and clinical investigations are intended for up to June 2021. The final results of this study are expected to be available at the end of 2021.ConclusionsOur findings will provide insights into the safety and feasibility of a new PT device based on light-emitting fabrics for the treatment of newborn jaundice. This new system, if proven effective, will improve the humanization of neonatal care and help avoid mother-child separation.Trial RegistrationClinicalTrials.gov NCT04365998; https://clinicaltrials.gov/ct2/show/NCT04365998International Registered Report Identifier (IRRID)PRR1-10.2196/24808

Comparison of the Predictive Accuracy of Stool Color for Triage of Infants for Phototherapy (STrIP) Score With Transcutaneous Bilirubinometer in Predicting Serum Bilirubin in Neonates

To compare the agreement of stool color for triage of infants for phototherapy (STrIP) score and transcutaneous bilirubinometer values with measured serum bilirubin in neonatal hyperbilirubinemia. Babies more than 35 weeks of gestation, with clinical jaundice, and on exclusive breastfeeding were included in the study. Babies with who were clinically unstable or who had received phototherapy based on clinical assessment were excluded. The agreement was analyzed using Bland-Altman charts. Results of three non-invasive methods were further compared with the measured serum bilirubin levels. There was a mean difference of 4 mg/dL of bilirubin between transcutaneous bilirubin and serum bilirubin levels, whereas the agreement between the STrIP score and Serum bilirubin shows a difference of only 2 mg/dL. On further analysis of Kramer, transcutaneous and STrIP score, method of bilirubin estimation against serum bilirubin, there was a mean difference 6 mg/dL, 4 mg/dL and 2 mg/dL, respectively. STrIP score has the best agreement with serum bilirubin in neonates compared to other non-invasive techniques such as transcutaneous bilirubinometry and clinical assessment using Kramer scale.

Transcutaneous Bilirubin Levels and Risk of Significant Hyperbilirubinemia in Early-Term and Term Newborns

ObjectiveTo compare the course of the transcutaneous bilirubin (TcB) values of early-term newborns with those of term newborns in the first month of life and to investigate whether early-term newborns have an increased risk of significant hyperbilirubinemia requiring treatment. DesignA prospective, controlled cohort analysis. SettingA tertiary level mother–child birth and health care center. ParticipantsFour hundred early-term (37 0/7 to 38 6/7 weeks) and 320 term (39 0/7 to 41 6/7 weeks) newborns born during a 27-month period. MethodsA total of six TcB measurements in a longitudinal manner were made in early-term and term newborns: the first two at 6 and 48 hours after birth and the next four on routine examination days (Days 4, 7, 15, and 30). Demographic characteristics, values of daily TcB measurements, number of newborns with significant hyperbilirubinemia, and risk of jaundice requiring treatment were compared between the two groups. ResultsAll six TcB values were significantly greater in the early-term group than in the term group (p < .001 for each). Early-term newborns had a statistically significant increased risk of jaundice requiring treatment compared to term newborns (risk ratio = 1.91; 95% confidence interval [1.23–2.96]; p = .0046). Results of the repeated-measures analysis of variance and post hoc adjusted multiple comparison analysis showed that TcB levels increased to and peaked at 96 hours after birth and then gradually decreased to baseline (first measurement) levels at 30 days after birth in each group. ConclusionsEarly-term newborns should not be treated as full-term newborns because they have significantly higher TcB levels. These newborns should be closely monitored for pathologic jaundice because they have increased risk for significant hyperbilirubinemia requiring phototherapy.

Most Proper Timing of Transcutaneous Bilirubin Measurement After Phototherapy Treatment in the Newborn Period

Background: There are limited data about the proper transcutaneous bilirubin measuring time to detect levels that are close to serum bilirubin levels after ending the phototherapy treatment. Objectives: To compare the transcutaneous bilirubin and total serum bilirubin levels, and to evaluate the reliability of transcutaneous bilirubin measurements after phototherapy treatment of newborns because of hyperbilirubinemia. Methods: The study included 105 late preterm and term newborns consisting of 56 females (53.3%) and 49 males (46.6%), with gestational age 350/7 - 416/7 weeks who were treated with phototherapy. A Bilicheck (M&amp;B-MBJ20) device was used for transcutaneous bilirubin measurements. The average of three measurements on the skin in the mid-sternal area were obtained. Correlations between transcutaneous bilirubin and venous bilirubin levels were evaluated 6 and 12 hours after phototherapy. Transcutaneous bilirubin measurements were performed simultaneously with blood collection or within a maximum ± 15 minutes time difference for total serum bilirubin. Results: The average phototherapy time was 10 ± 2 (range, 8 - 12) hours. The average difference between transcutaneous bilirubin and venous bilirubin levels post phototherapy was 2.61 mg/dL after 6 hours and 0.8 mg/dL after 12 hours. The hematocrit levels of the patients ranged between 40 - 66% with an average of 53% ± 4.8, the median level was 51%. Correlation coefficients according to hours after treatment were high for the 6th hour (r = 0.76) and very high for the 12th hour. Conclusions: Jaundice scanning with transcutaneous bilirubin measurements 6 - 12 hours after the end of phototherapy is reliable and may be helpful in preventing additional blood collection from the heel.

The risk of hyperbilirubinemia in term neonates after placental transfusion - a randomized-blinded controlled trial.

We aimed to demonstrate non-inferiority of delayed cord clamping (DCC) and cord milking (CM) in comparison to early cord clamping (ECC) in the incidence of hyperbilirubinemia requiring phototherapy. 467 of maternal-foetal dyads were screened for eligibility. 389 term infants, of breastfeeding, non-smoking mothers were randomized to receive ECC ( < 40 s), DCC (1-2 min) or CM (4 times towards the neonate). The primary outcome was defined as hyperbilirubinemia requiring phototherapy. 307 patients were included in the analysis. CM did not increase the risk of phototherapy RR 11.27 95% CI (0.80; 2.04). Similar results were achieved when comparing DCC and ECC, RR 1.29 95% CI (0.82; 2.05). This was also true for CM vs DCC, RR 0.99 95% CI (0.64; 1.52). The prevalence of total serum bilirubin (TSB) at 24-48 hours was 10.8 mg/dL; 10.33 mg/dL and 11.39 in ECC, CM and DCC group respectively. Transcutaneous bilirubin (TcB) levels at 24-48 h were 7.58 mg/dL, 7.89 mg/dL and 7.60 mg/dL in the ECC, CM and DCC respectively. None of the neonates met exchange transfusion criteria or symptomatic polycythaemia. Our study suggests that placental transfusion is not associated with hyperbilirubinemia requiring phototherapy or exchange transfusion.

Remote monitoring of neonatal jaundice in newborns with ABO hemolytic disease

To explore the feasibility of remote monitoring of neonatal jaundice in newborns with ABO hemolytic disease. Forty six neonates of gestational age >35 weeks with ABO hemolytic disease admitted to Women's Hospital, Zhejiang University School of Medicine from January 20th, 2020 to February 29th, 2020 were enrolled in the study (study group). The newborns were followed up at home after discharge, the transcutaneous bilirubin (TCB) levels were measured by parents using the provided device and the results were sent to the doctor by smart phone using the installed APP. Fifty six newborns with ABO hemolytic disease admitted in 2018 who received conventional outpatient follow-up after discharge served as the control group. The demographic characteristics, total serum bilirubin (TSB) level during hospitalization, number of outpatient visit and rate of re-admission due to rebound hyperbilirubinemia were compared between the two groups. There were no significant differences between the two groups in gestational age, birth weight, delivery mode, gender, length of the first hospitalization, TSB level before phototherapy and before discharge, and the managements during the first hospitalization (all P>0.05). Compared with the control group, TSB level before readmission [(265±16) μmol/L vs. (295±15) μmol/L] and the number of outpatient visits (1.3±0.8 vs. 3.8±0.5) were significantly lower in the study group (all P<0.01), while the rate of readmission (17.4%vs. 12.5%) and the weight at the time of readmission[(3398±452) g vs. (3477±324) g] were not significantly different (all P>0.05). No cases of acute bilirubin encephalopathy occurred in both groups. The remote follow-up for neonatal jaundice at home can effectively reduce the number of outpatient visits without increasing the risk of readmission and severe neonatal hyperbilirubinemia for newborns with ABO hemolytic disease.