Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia.

INTRODUCTION: Early diagnosis and appropriate management of neonatal jaundice is crucial in avoiding severe hyperbilirubinemia and brain injury. A low-cost, minimally invasive, point-of-care (PoC) tool for total bilirubin (TB) estimation which can be useful across all ranges of bilirubin values and all settings is the need of the hour. OBJECTIVE: To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in comparison with estimation by spectrophotometry. DESIGN/METHODS: In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-µl sample transfer pipettes were collected at the same time from venous blood obtained for laboratory bilirubin estimation. The accuracy of Bilistick in estimating TB within ±2 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome. RESULTS: Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 ± 2.3 weeks and the mean birth weight of 2368 ± 623 g. The median age at enrollment was 68.5 h (interquartile range: 48-92). Bilistick was accurate only in 54.5% infants in measuring TB within ±2 mg/dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods (r = 0.457; 95% CI: 0.339-0.561, p value < 0.001). Bland-Altman analysis showed a mean difference of 0.5 mg/dl (SD ± 4.4) with limits of agreement between -8.2 and +9.1 mg/dl. CONCLUSION: Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate.

A Novel Icterometer for Hyperbilirubinemia Screening in Low-Resource Settings.

BACKGROUND: Severe neonatal hyperbilirubinemia (>20 mg/dL) affects ∼1 million infants annually. Improved jaundice screening in low-income countries is needed to prevent bilirubin encephalopathy and mortality. METHODS: The Bili-ruler is an icterometer for the assessment of neonatal jaundice that was designed by using advanced digital color processing. A total of 790 newborns were enrolled in a validation study at Brigham and Women's Hospital (Boston) and Sylhet Osmani Medical College Hospital (Sylhet, Bangladesh). Independent Bili-ruler measurements were made and compared with reference standard transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) concentrations. RESULTS: Bili-ruler scores on the nose were correlated with TcB and TSB levels (r = 0.76 and 0.78, respectively). The Bili-ruler distinguished different clinical thresholds of hyperbilirubinemia, defined by TcB, with high sensitivity and specificity (score ≥3.5: 90.1% [95% confidence interval (CI): 84.8%-95.4%] and 85.9% [95% CI: 83.2%-88.6%], respectively, for TcB ≥13 mg/dL). The Bili-ruler also performed reasonably well compared to TSB (score ≥3.5: sensitivity 84.5% [95% CI: 79.1%-90.3%] and specificity 83.2% [95% CI: 76.1%-90.3%] for TSB ≥11 mg/dL). Areas under the receiver operating characteristic curve for identifying TcB ≥11, ≥13, and ≥15 were 0.92, 0.93, and 0.94, respectively, and 0.90, 0.87, and 0.86 for identifying TSB ≥11, ≥13, and ≥15. Interrater reliability was high; 97% of scores by independent readers fell within 1 score of one another (N = 88). CONCLUSIONS: The Bili-ruler is a low-cost, noninvasive tool with high diagnostic accuracy for neonatal jaundice screening. This device may be used to improve referrals from community or peripheral health centers to higher-level facilities with capacity for bilirubin testing and/or phototherapy.

Learning from claims: hyperbilirubinaemia and kernicterus.

We examined claims made against the National Health Service (NHS) involving neonatal jaundice in order to determine whether there were lessons that could be learnt from common themes.This was a retrospective anonymised study using information from the NHS Resolution database for 2001-2011.Twenty cases (16 males) had sufficient information for analysis. Fifteen had confirmed cerebral palsy and two young children had damage to the globus pallidus without confirmed CP. In three cases, the outcome was uncertain. Two were extremely preterm, five were born at 34-36 weeks' gestation. Jaundice was typically present very early in life; in four cases, it was noted at less than 24hours of age, and in 14 cases, it was first noted on the second to third day. There was a lag between recognition and readmission, with a range of 26-102 hours. The peak serum bilirubin level was over 600 µmol/L in all the babies born at term. An underlying diagnosis was found in all but two; six had glucose-6-phosphatase deficiency (one also had Gilbert's syndrome); five were diagnosed with ABO incompatibility; three with Rh haemolytic disease; one with spherocytosis and three preterm. The total cost of these claims by August 2017 was almost £150.5 million. This figure is likely to rise.These data show that, in the group who litigate, babies who develop kernicterus generally have an underlying diagnosis. We recommend adherence to theNational Institute for Health and Care Excellence guideline that recommends measuring the bilirubin level within 6 hours in all babies who are visibly jaundiced.

Comparison of Transcutaneous and Serum Bilirubin Measurements in Neonates 30 to 34 Weeks' Gestation Before, During, and After Phototherapy.

BACKGROUND: The use of noninvasive, transcutaneous bilirubin monitoring (TcB) as a jaundice screen in full-term infants is well established; however, there is a paucity of research evaluating the use of TcB in premature infants. PURPOSE: To compare agreement and consistency of transcutaneous and serum bilirubin measurements in a multiracial premature infant population ranging from 30 to 34(Equation is included in full-text article.)weeks' gestation before, during, and after phototherapy. METHODS: Forty-five neonates, 30 to 34(Equation is included in full-text article.)weeks' gestation, were enrolled in this prospective, correlational study over a 12-month period. One set of paired transcutaneous and serum bilirubin measurements, per neonate, was obtained before phototherapy, during therapy, and after phototherapy. Exclusion criteria included neonates with positive direct coombs test or evidence of hemolytic disease, major congenital anomalies, hydrops fetalis, and those not expected to survive. RESULTS: There was a strong, positive correlation between TcB and total serum monitoring (TSB) measurements obtained pretherapy (r = 0.797, P < .001). A moderate correlation was noted between TcB and TSB measurements obtained during therapy (r = 0.588, P < .001). A strong correlation was noted between TcB and TSB measurements obtained posttherapy (r = 0.869, P < .001). There were no significant differences between paired samples across time (F = 0.891, P = .41, partial η = 0.01). The TSB measurements were consistently lower than TcB pretherapy, during, and posttherapy. IMPLICATIONS FOR PRACTICE: The TcB measurements provide a reliable estimation, generally within 2 to 3 mg/dL of TSB levels, in premature infants 30 to 34(Equation is included in full-text article.)weeks' gestation. IMPLICATIONS FOR RESEARCH: Investigation of consumption of time and nursing personnel required to perform TcB testing, compared with TSB testing, is indicated. Cost analyses comparing TcB-driven screening protocols and interval TSB measurements, among premature infants, are indicated. As newer generations of TcB devices are approved for use, additional studies using mixed-race populations of premature infants will be necessary to continue to evaluate the reliability and validity of this screening tool within the everyday neonatal intensive care unit.

Rationalized assessment of prolonged jaundice is safe and cost-effective.

Prolonged jaundice (PJ) in healthy term neonates is common and frequently benign. It can, however, be the earliest manifestation of underlying liver disease. Its management requires a balanced approach, avoiding over-investigation of well babies while ensuring the early identification of those with pathology. Currently marked heterogeneity exists in the assessment of PJ. Over a two-year period we prospectively audited the management of PJ in two Level 3 neonatal units prior to and after the introduction of a rationalized investigation algorithm in keeping with the recently published British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) guidelines (i.e. clinical examination and stool inspection combined with measurement of split bilirubin). In this study we reviewed initial practice and then evaluated the impact of our change in practice. A total of 197 babies, 1.5% of live births, were referred with PJ. Of these, 105 babies were included in the first part of the study and 92 babies were included in the second part. No pathology relating to PJ, such as infection, hepatitis or liver disease, was identified. Following the introduction of our rationalized algorithm, we demonstrated a statistically significant reduction in the number of return appointments (28 versus 7; P < 0.0009) and repeat investigations (37 versus 7; P < 0.0001). This represented a saving of £1575-2625 per year in laboratory costs alone. Contemporaneously, three infants presented with biliary atresia, none of whom were identified by PJ screening and all of whom were over seven weeks old at diagnosis. A rationalized approach to the assessment of PJ reduces workload and is cost-effective; however, the limitations of selective screening, irrespective of how streamlined it is, remain--if babies are not identified and referred, they cannot be screened. Population-based methodologies offer an alternative approach to the identification of cholestatic liver disease and are worthy of further consideration.

A global need for affordable neonatal jaundice technologies.

Globally, health care providers worldwide recognize that severe neonatal jaundice is a "silent" cause of significant neonatal morbidity and mortality. Untreated neonatal jaundice can lead to death in the neonatal period and to kernicterus, a major cause of neurologic disability (choreo-athetoid cerebral palsy, deafness, language difficulty) in children who survive this largely preventable neonatal tragedy. Appropriate technologies are urgently needed. These include tools to promote and enhance visual assessment of the degree of jaundice, such as simpler transcutaneous bilirubin measurements and readily available serum bilirubin measurements that could be incorporated into routine treatment and follow-up. Widespread screening for glucose-6-phoshate dehydrogenase deficiency is needed because this is often a major cause of neonatal jaundice and kernicterus worldwide. Recognition and treatment of Rh hemolytic disease, another known preventable cause of kernicterus, is critical. In addition, effective phototherapy is crucial if we are to make kernicterus a "never-event." Finally it is essential that we conduct appropriate population-based studies to accurately elucidate the magnitude of the problem. However, knowledge alone is not sufficient. If we are to implement these and other programs and technologies to relegate severe neonatal jaundice and its sequelae to the history books, screening and interventions must be low cost and technologically appropriate for low and middle income nations.

The need to implement effective phototherapy in resource-constrained settings.

Phototherapy is the treatment of choice to reduce the severity of neonatal unconjugated hyperbilirubinemia regardless of its etiology. Its implementation requires a technical framework that conforms to existing evidence-based guidelines that promote its safer and effective use worldwide. Optimal use of phototherapy has been defined by specific ranges of total serum bilirubin thresholds configured to an infant's postnatal age (in hours) and potential risk for bilirubin neurotoxicity. Effective phototherapy implies its use at specific blue light wavelengths (peak emission, 450 ± 20 nm) and emission spectrum (range, 400-520 nm), preferably in a narrow bandwidth that is delivered at an irradiance of ≥30 µW/cm(2)/nm to up to 80% of an infant's body surface area. However, this is often not feasible in clinical settings with limited or constrained resources. To identify and bridge implementation barriers, we propose minimum criteria for device performance for safe and practical use of phototherapy as a prophylactic intervention to prevent severe hyperbilirubinemia.

Efficacy of phototherapy for neonatal jaundice is increased by the use of low-cost white reflecting curtains.

OBJECTIVE: To determine whether the addition of low-cost reflecting curtains to a standard phototherapy unit could increase effectiveness of phototherapy for neonatal jaundice. DESIGN: Randomised controlled clinical trial. SETTING: Level-one nursery of the Hospital Universiti Sains Malaysia, Kelantan, Malayasia. PATIENTS: Term newborns with uncomplicated neonatal jaundice presenting in the first week of life. INTERVENTIONS: Phototherapy with white curtains hanging from the sides of the phototherapy unit (study group, n = 50) was compared with single phototherapy without curtains (control group, n = 47). MAIN OUTCOME MEASURES: The primary outcome was the mean difference in total serum bilirubin measured at baseline and after 4 h of phototherapy. The secondary outcome was the duration of phototherapy. RESULTS: The mean (standard deviation) decrease in total serum bilirubin levels after 4 h of phototherapy was significantly (p<0.001) higher in the study group (27.62 (25.24) micromol/l) than in the control group (4.04 (24.27) micromol/l). Cox proportional hazards regression analysis indicated that the median duration of phototherapy was significantly shorter in the study group (12 h) than in the control group (34 h; chi(2) change 45.2; p<0.001; hazards ratio 0.20; 95% confidence interval 0.12 to 0.32). No difference in adverse events was noted in terms of hyperthermia or hypothermia, weight loss, rash, loose stools or feeding intolerance. CONCLUSION: Hanging white curtains around phototherapy units significantly increases efficacy of phototherapy in the treatment of neonatal jaundice without evidence of increased adverse effects.

Cost-effectiveness of postnatal home nursing visits for prevention of hospital care for jaundice and dehydration.

OBJECTIVES: (1) To describe the relationship between postnatal home nursing visitation and readmissions and emergency department (ED) visits for neonatal jaundice and dehydration in the first 10 days of life. (2) To evaluate the cost-effectiveness of providing home nursing visits after newborn discharge with specific attention to prevention of jaundice and dehydration that require hospital-based services. METHODS: A retrospective analysis of a financial database allowed for review of the discharge disposition and subsequent care for all neonates who were born at a single center from January 2000 through December 2002. Financial data reflect reimbursement values and costs of care from the payers' perspective at the single center. We performed a deterministic cost-effectiveness analysis using a decision tree that reflected the costs and probabilities of infants in each particular health state after nursery discharge. RESULTS: A total of 73 (2.8%) of 2641 newborns who did not receive a home visit were readmitted to the hospital in the first 10 days of life with jaundice and/or dehydration compared with 2 (0.6%) of 326 who did receive a home visit. Similarly, 92 (3.5%) of 2641 newborns who were discharged without subsequent home nursing care had an ED visit for these reasons in the first 10 days of life compared with 0 (0%) of 326 who did have such a visit. Of infants who received a home visit, 324 (99.4%) of 326 did not require subsequent hospital services in this time period compared with 2497 (94.5%) of 2641 of those who did not receive a visit. After nursery discharge, the average cost per child who received a home health visit was 109.80 dollars compared with 118.70 dollars for each newborn who did not receive a visit. The incremental cost-effectiveness ratio of a routine home visit strategy compared with a no visit strategy was -181.82 dollars. CONCLUSIONS: A home nursing visit after newborn nursery discharge is highly cost-effective for reducing the need for subsequent hospital-based services.

Breast-feeding, neonatal jaundice and kernicterus.

Despite the many advantages of breast-feeding, there is ample documentation of the strong association between breast-feeding and an increase in the risk of neonatal hyperbilirubinaemia. Breast-fed infants have higher bilirubin levels than formula-fed infants. Suggested mechanisms for these findings include poor fluid and caloric intake, inhibition of hepatic excretion of bilirubin, and intestinal absorption of bilirubin (enterohepatic circulation). On rare occasions, breast-fed infants without evidence of haemolysis have developed extreme hyperbilirubinaemia and kernicterus. Because almost all of the cases of kernicterus reported in the last 15 years have occurred in fully or partially breast-fed newborns, it is important that these infants be followed closely. Appropriate support and advice must be provided to the lactating mother so that successful breast-feeding can be established and the risk of severe hyperbilirubinaemia reduced.

Costo-efectividad en la atención hospitalaria de algunas patológías / Cost-effectiveness in hospital care of some pathologies

Se presentan los resultados del estudio de costo-efectividad realizado en enfermos internados en hospitales públicos del sector norte de Santiago. Corresponden a 181 pacientes con colelitiasis, apendicitis aguda, hernias abdominales, úlceras duodenales, adenoma prostático, embarazo ectópico, IRA e ictericias del recién nacido. Para estimar el costo de la atención médica se emplearon los valores FONASA de Pago Asociado a Diagnóstico (PAD) para estas patologías. La efectividad fue medida por el porcentaje de recuperación completa observada en el seguimiento domiciliario realizado 30 días y 6 meses después del alta. En conjunto, los pacientes tuvieron un 70,2 por ciento de recuperación a 30 días y 84 por ciento a 6 meses plazo. Como el costo promedio de hospitalización alcanzó a $ 414.000, la relación costo-efectividad a 30 días fue de $ 5.900 y a 6 meses de $ 4.960, montos que indican el gasto necesario para mejorar en un punto poncentual el porcentaje de recuperación completa de los pacientes. El costo-efectividad resultó más alto para patologías de manejo quirúrgico, para el género femenino, para adultos de edad media y para beneficiarios de FONASA. Mientras en la atención primaria una buena ecuación de costo-efectividad depende más de la proporción de recuperación de los pacientes que de bajos costos de atención médica, en el caso de la atención hospitalaria el costo-efectividad está fundamentalmente ligado a los costos de operación

Laboratory evaluation of jaundice in newborns. Frequency, cost, and yield.

Neonates with hyperbilirubinemia commonly undergo a battery of laboratory tests. We used a computerized database and medical records to study the frequency, cost, and yield of these tests in 2443 infants born at the University of California, San Francisco, between 1980 and 1982. Four hundred forty-seven (18%) of the infants met standard criteria for "nonphysiologic" hyperbilirubinemia; the incidence varied from 9% in blacks to 31% in Asian infants. About 55% of these 447 infants received a $125 "hyperbilirubinemia workup." Hospital discharge diagnoses on all 447 hyperbilirubinemic infants were reviewed. In 214 (48%), no cause of the jaundice was identified. An additional 145 (32%) had a possible cause apparent from history, physical examination, or initial hematocrit determination. The only diagnosis made as a result of routine investigations of hyperbilirubinemia was possible ABO or Rh isoimmunization in 75 infants (17%). Nonphysiologic hyperbilirubinemia may be more common than previously reported. The recommended tests are expensive and rarely lead to diagnoses other than ABO or Rh isoimmunization. Their routine use should be reevaluated.

Breast feeding and jaundice in the first week of life.

Infants who most commonly receive treatment for neonatal hyperbilirubinemia are breast-fed babies in whom no cause for the jaundice can be determined. Hyperbilirubinemia in these newborns may not be caused by the breast feeding as such, but rather by inadequate nursing. This paper reports attempts to decrease readmissions for phototherapy at the UCLA Medical Center by inducing earlier and more functional lactation in the entire nursery population and by formula feeding infants whose bilirubins approached recommended treatment levels. Nursing was interrupted for 24 to 48 hours in 87 newborns; six still required readmission, while 81 were successfully treated at home. At the two-week well-baby visit, no differences in the incidence of breast feeding were found when comparing nonjaundiced breast-fed babies with infants who were taken off the breast or who were readmitted for phototherapy. Differences in the cost of care were significant with an average cost per patient of $126 for those treated at home compared with $1,440 for those readmitted. Policies designed to induce earlier lactation did nothing to decrease the incidence of exaggerated jaundice in the study's breast-fed population. It was concluded that supervised setting with careful counseling and follow-up, can provide an effective alternative to readmission and phototherapy in the treatment of jaundice.