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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.
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Bilirrubina/sangre , Hiperbilirrubinemia Neonatal/diagnóstico , Ictericia Neonatal/diagnóstico , Tamizaje Neonatal/instrumentación , Sistemas de Atención de Punto/organización & administración , Biomarcadores/sangre , Estudios Transversales , Femenino , Humanos , Hiperbilirrubinemia Neonatal/sangre , Hiperbilirrubinemia Neonatal/economía , Hiperbilirrubinemia Neonatal/etnología , India/epidemiología , Recién Nacido , Ictericia Neonatal/sangre , Ictericia Neonatal/economía , Ictericia Neonatal/etnología , Masculino , Tamizaje Neonatal/economía , Sistemas de Atención de Punto/economía , Valor Predictivo de las Pruebas , Estudios Prospectivos , Tiras Reactivas/economía , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Factores de TiempoRESUMEN
BACKGROUND: Severe neonatal hyperbilirubinemia (>20 mg/dL) affects â¼1 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.
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Recursos en Salud/economía , Ictericia Neonatal/diagnóstico , Ictericia Neonatal/economía , Tamizaje Neonatal/economía , Tamizaje Neonatal/instrumentación , Adulto , Bangladesh/epidemiología , Boston/epidemiología , Color , Femenino , Recursos en Salud/tendencias , Humanos , Hiperbilirrubinemia Neonatal/diagnóstico , Hiperbilirrubinemia Neonatal/economía , Hiperbilirrubinemia Neonatal/epidemiología , Recién Nacido , Ictericia/diagnóstico , Ictericia/economía , Ictericia/epidemiología , Ictericia Neonatal/epidemiología , Masculino , Tamizaje Neonatal/tendencias , Adulto JovenRESUMEN
BACKGROUND: Prevalence of hemolytic neonatal hyperbilirubinemia (NHB) is not well characterized, and economic burden at the population level is poorly understood. This study evaluated the prevalence, clinical characteristics, and economic burden of hemolytic NHB newborns receiving treatment in U.S. real-world settings. METHODS: This cohort study used administrative claims from 01/01/2011 to 08/31/2017. The treated cohort had hemolytic NHB diagnosis and received phototherapy, intravenous immunoglobulin, and/or exchange transfusions. They were matched with non-NHB newborns who had neither NHB nor related treatments on the following: delivery hospital/area, gender, delivery route, estimated gestational age (GA), health plan eligibility, and closest date of birth within 5 years. Inferential statistics were reported. RESULTS: The annual NHB prevalence was 29.6 to 31.7%; hemolytic NHB, 1.8 to 2.4%; treated hemolytic NHB, 0.46 to 0.55%, between 2011 and 2016. The matched analysis included 1373 pairs ≥35 weeks GA. The treated hemolytic NHB cohort had significantly more birth trauma and hemorrhage (4.5% vs. 2.4%, p = 0.003), vacuum extractor affecting newborn (1.9% vs. 0.8%, p = 0.014), and polycythemia neonatorum (0.8% vs. 0%, p = 0.001) than the matched non-NHB cohort. The treated hemolytic NHB cohort also had significantly longer mean birth hospital stays (4.5 vs. 3.0 days, p < 0.001), higher level 2-4 neonatal intensive care admissions (15.7% vs. 2.4, 15.9% vs. 2.8 and 10.6% vs. 2.5%, respectively, all p < 0.001) and higher 30-day readmission (8.7% vs. 1.7%, p < 0.001). One-month and one-year average total costs of care were significantly higher for the treated hemolytic NHB cohort vs. the matched non-NHB cohort, $14,405 vs. $5527 (p < 0.001) and $21,556 vs. $12,986 (p < 0.001), respectively. The average costs for 30-day readmission among newborns who readmitted were $13,593 for the treated hemolytic NHB cohort and $3638 for the matched non-NHB cohort, p < 0.001. The authors extrapolated GA-adjusted prevalence of treated hemolytic NHB in the U.S. newborn population ≥ 35 weeks GA and estimated an incremental healthcare expenditure of $177.0 million during the first month after birth in 2016. CONCLUSIONS: The prevalence of treated hemolytic NHB was 4.6-5.5 patients per 1000 newborns. This high-risk hemolytic NHB imposed substantial burdens of healthcare resource utilization and incremental costs on newborns, their caregivers, and the healthcare system.
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Costo de Enfermedad , Hiperbilirrubinemia Neonatal/economía , Hiperbilirrubinemia Neonatal/epidemiología , Adulto , Cuidados Críticos/economía , Recambio Total de Sangre/estadística & datos numéricos , Utilización de Instalaciones y Servicios , Femenino , Edad Gestacional , Costos de la Atención en Salud/estadística & datos numéricos , Humanos , Hiperbilirrubinemia Neonatal/terapia , Inmunoglobulinas Intravenosas/uso terapéutico , Recién Nacido , Cobertura del Seguro , Unidades de Cuidado Intensivo Neonatal/economía , Tiempo de Internación/economía , Masculino , Readmisión del Paciente/economía , Fototerapia/estadística & datos numéricos , Prevalencia , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVES: Newborns hospitalized with unconjugated hyperbilirubinemia without critical comorbidities may receive intensive phototherapy (IP) in non-ICU levels of care, such as a mother-newborn unit, or ICU levels of care. Our aim was to compare outcomes between each level. METHODS: Using hospital discharge data from 2005 to 2011 in New York's State Inpatient Database, we performed multivariate analyses to compare outcomes that included total cost of hospitalization, length of stay, 30-day readmission rate after IP, and the number of cases of death, exchange transfusion, and γ globulin infusion. We included term newborns treated with IP in their first 30 days of life and without diagnosis codes for other critical illnesses. Explanatory variables included level of care, sex, race, insurance type, presence or absence of hemolysis, hospital, volume of IP performed at each hospital, and year of hospitalization. RESULTS: Ninety-nine percent of IP was delivered in non-ICU levels of care. Incidence of major complications was rare (≤0.1%). After adjusting for confounders, ICU level of care was not associated with difference in length of stay (relative risk: 1.2; 95% confidence interval [CI]: 0.91 to 1.15) or 30-day readmission rate (odds ratio: 0.74; 95% CI: 0.50 to 1.09) but was associated with 1.51 (95% CI: 1.47 to 1.56) times higher costs. CONCLUSIONS: For otherwise healthy term newborns with jaundice requiring IP, most received treatment in a non-ICU level of care, and those in intensive care had no difference in outcomes but incurred higher costs. IP guideline authors may want to be more prescriptive about IP level of care to improve value.
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Hiperbilirrubinemia Neonatal/terapia , Fototerapia/métodos , Bases de Datos Factuales , Femenino , Costos de Hospital/estadística & datos numéricos , Hospitalización/economía , Humanos , Hiperbilirrubinemia Neonatal/economía , Recién Nacido , Unidades de Cuidado Intensivo Neonatal/economía , Cuidado Intensivo Neonatal/economía , Masculino , New York , Fototerapia/economía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Severe neonatal hyperbilirubinemia, with consequent encephalopathy, remains a common cause of morbidity and death in many regions of the world. Poor access to clinical laboratory resources and screening programs to measure plasma bilirubin levels is a major contributor to delayed treatment in developing countries, and the cost of existing point-of-care screening instruments precludes their dissemination. OBJECTIVES: We are evaluating the accuracy of a low-cost, minimally invasive point-of-care system (Bilistick) requiring a 25-µl blood sample that could be used in low-resource environments to evaluate patients with neonatal jaundice. METHODS: We compared plasma bilirubin levels in divided blood samples by clinical laboratories and by Bilistick at two medical centers serving term and near-term newborns from ethnically different populations. RESULTS: 118 neonates with bilirubin levels ranging from 24.8 to 501.0 µmol/l were analyzed. The mean bilirubin concentration (±SD) was 215.6 ± 85.5 µmol/l for Bilistick and 226.1 ± 86.4 µmol/l by laboratory determination. Pearson's correlation coefficient between all paired results was 0.961, and the Bland-Altman analysis showed a mean difference of 10.3 µmol/l with a 95% interval of agreement of -38.0 to 58.7 µmol/l. CONCLUSION: Bilistick is a minimally invasive method for measuring total bilirubin concentration over a wide range of values and should provide an affordable and accurate system for pre-discharge and follow-up screening of jaundiced infants, particularly in low-resource environments.
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Bilirrubina/sangre , Hiperbilirrubinemia Neonatal/diagnóstico , Tamizaje Neonatal/instrumentación , Sistemas de Atención de Punto , Tiras Reactivas , Biomarcadores/sangre , Egipto/epidemiología , Costos de Hospital , Humanos , Hiperbilirrubinemia Neonatal/sangre , Hiperbilirrubinemia Neonatal/economía , Hiperbilirrubinemia Neonatal/etnología , Recién Nacido , Italia/epidemiología , Tamizaje Neonatal/economía , Variaciones Dependientes del Observador , Sistemas de Atención de Punto/economía , Valor Predictivo de las Pruebas , Tiras Reactivas/economía , Reproducibilidad de los ResultadosRESUMEN
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.
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Necesidades y Demandas de Servicios de Salud/economía , Hiperbilirrubinemia Neonatal/terapia , Ictericia Neonatal/terapia , Fototerapia/métodos , Países en Desarrollo/economía , Humanos , Hiperbilirrubinemia Neonatal/tratamiento farmacológico , Hiperbilirrubinemia Neonatal/economía , Recién Nacido , Ictericia Neonatal/tratamiento farmacológico , Ictericia Neonatal/economía , Fototerapia/economíaRESUMEN
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.