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Neonatal Hyperbilirubinemia, Kernicterus and Non -Invasive Bilirubin Measurements M.Jeffrey Maisels, M.D.

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Neonatal Hyperbilirubinemia, Kernicterus and Non -Invasive Bilirubin Measurements M.Jeffrey Maisels, M.D.

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    1. Neonatal Hyperbilirubinemia, Kernicterus and Non -Invasive Bilirubin Measurements M.Jeffrey Maisels, M.D.

    2. Why worry about jaundice? Occurs in almost all babies Source of anxiety and aggravation to families and doctors Can lead to kernicterus

    4. Recent Papers Documenting Kernicterus Penn AA, Enzman DR, Hahn JS, et al. Kernicterus in a full term infant. Pediatrics 1994;93:1003-1006. Washington EC, Ector W, Abboud M, et al. Hemolytic jaundice due to G6PD deficiency causing kernicterus in a female newborn. South Med J 1995;88:776-779 Maisels MJ, Newman TB. Kernicterus in otherwise healthy, breast-fed term newborns. Pediatrics 1995;96:730-733. MacDonald M. Hidden risks: early discharge and bilirubin toxicity due to glucose-6-phosphate dehydrogenase deficiency. Pediatrics 1995;96:734-738. Stanley TV. A case of kernicterus in New Zealand: a preventable tragedy? J Paediatr Child Health 1997;33:451-543

    5. Recent Papers Documenting Kernicterus Penn AA, Enzman DR, Hahn JS, et al. Kernicterus in a full term infant. Pediatrics 1994;93:1003-1006. Washington EC, Ector W, Abboud M, et al. Hemolytic jaundice due to G6PD deficiency causing kernicterus in a female newborn. South Med J 1995;88:776-779 Maisels MJ, Newman TB. Kernicterus in otherwise healthy, breast-fed term newborns. Pediatrics 1995;96:730-733. MacDonald M. Hidden risks: early discharge and bilirubin toxicity due to glucose-6-phosphate dehydrogenase deficiency. Pediatrics 1995;96:734-738. Stanley TV. A case of kernicterus in New Zealand: a preventable tragedy? J Paediatr Child Health 1997;33:451-543

    9. Acute Kernicterus 1984-2000 80 infants reported in literature, personal communication, litigation 66% male All breastfed (except 2 G6PD deficient) Discharged at 12-75 hr 33% <37 weeks

    10. Kernicterus Still occurring ? 100 cases in 15 years (Johnson et al. J Pediatr 2002;140:396) A rare disease but, unlike other causes of CP, almost always preventable 5,000 new cases of CP/yr in the US

    12. Pediatricians have forgotten that the bilirubin level must be interpreted in terms of the baby’s age in hours - not days

    14. Pediatricians have not adjusted their practices to the fact that babies now leave the hospital by 36 hours

    15. Pediatricians do not recognize the innacuracies of the visual assessment of jaundice

    17. We do not respond appropriately to parental concerns about jaundice, poor feeding and changes in newborn behavior

    18. We are seeing more jaundiced babies

    22. AAP Guideline -Timing of Follow-up

    23. Noninvasive Measurements of Bilirubin – Transcutaneous Bilirubinometry Need a rapid, noninvasive method for measuring serum bilirubin Visual estimates of the bilirubin level are inaccurate Use total serum bilirubin (TSB) to predict risk determine when intervention is necessary

    25. Predischarge Bilirubin Levels and Risk of Subsequent Hyperbilirubinemia

    26. RISK OF DEVELOPING A BILIRUBIN > 20 mg/dL

    27. Noninvasive Measurement of Total Serum Bilirubin in Multiracial Predischarge Newborn Population to Assess the Risk of Severe Hyperbilirubinemia Bhutani VK et al. Pediatrics 2000;106:e17

    29. BiliChek Measures TcB utilizing the entire spectrum of visible light (380-760 nm) reflected by the skin White light transmitted into the skin and reflected light collected for analysis Absorption of hemoglobin, melanin and dermal thickness isolated mathematically, and absorption of light due to bilirubin in the capillary bed and subcutaneous tissue isolated by spectral subtraction Measurement should be independent of race, age, gestation and birth weight

    30. Schematic of Spectral Reflectance

    33. Prediction of 95th Percentile by BiliChek at 24-72 hr (n=419)

    34. Transcutaneous Bilirubin Measurement  A Multicenter Evaluation Of a New Device Rubaltelli FF, et al. Pediatrics 2001;107:1264-1271

    35. Rubaltelli et al. 6 hospitals in England, France, Switzerland, Italy, Germany 210 infants (140 white, 31 Asian, 14 Hispanic, 9 African, 16 other) – 35 at each site TcB measurements performed within 30 minutes of TSB TSB by individual hospital laboratory and by HPLC (Glen Gourley MD, University of Wisconsin)

    36. No Effect on TcB Measurements Gestational age Birth weight Post natal age  Rubaltelli, Pediatrics 2001;107:1264

    39. Correlation of HPLC vs BiliCheck similar to HPLC vs laboratory TSB TcB slightly better than laboratory at higher TSB TcB equivalent to laboratory TSB at HPLC bilirubin of 13 mg/dL (using cut off of 11 mg/dL on TcB) Should be able to avoid “vast majority of blood tests” Rubaltelli, Pediatrics 2001;107:1264

    40. Assessment of Transcutaneous Device in the Evaluation of Neonatal Hyperbilirubinemia in Primarily Hispanic Population Engle WD, Jackson GL, Sendelbach D et al. Pediatrics 2002;110:61-67 248 Hispanic and 56 non-Hispanic neonates > 35 wks and birth weight > 2100 g TSB measured on clinical indication TcB (BiliChek) measured from the forehead within 30 minutes of TSB

    42. TSB > 15 mg/dL in 31% of Hispanic neonates BiliChek tended to underestimate TSB particularly when TSB > 10 mg/dL

    46. Maisels MJ, Ostrea EM Jr, Touch S et al. Convenience sample of 849 newborns > 35 wks gestation in newborn nursery and outpatient follow-up William Beaumont Hospital, Hutzel Hospital, Thomas Jefferson University Hospital Population groups white 59.2% (n=503), black 29.8% (n=253), East Asian 4.5% (n=38), Middle Eastern 3.8% (n=32), Indian-Pakistani 1.6% (n=14), Hispanic 1.1% (n=9)

    47. Maisels MJ, Ostrea EM Jr, Touch S et al. Convenience sample of 849 newborns > 35 wks gestation in newborn nursery and outpatient follow-up William Beaumont Hospital, Hutzel Hospital, Thomas Jefferson University Hospital Population groups white 59.2% (n=503), black 29.8% (n=253), East Asian 4.5% (n=38), Middle Eastern 3.8% (n=32), Indian-Pakistani 1.6% (n=14), Hispanic 1.1% (n=9)

    59. White Infants n=503

    60. Black Infants n=253

    61. All Other Infants n=93

    62. JM-103 Effect of Gestational Age on Accuracy

    63. JM-103 Effect of Gestational Age on Accuracy

    64. BiliChek and JM-103

    65. Impact of TcB on Number of TSB Measurements

    66. Transcutaneous Bilirubinometry – Current Status BiliChek and JM-103 provide acceptable correlations in infants > 35 wks gestation BiliChek compares favorably with standard laboratory bilirubin vs HPLC BiliChek appears to work well in multiracial populations but may be less accurate at TSB > 15 mg/dL

    67. Transcutaneous Bilirubinometry – Current Status BiliChek can be used as predischarge screen to identify infants with TSB values above 95th percentile JM-103 easier to use (and ? cheaper) than BiliChek but may be less accurate in black infants In black infants JM-103 generally over estimates TSB value so should not miss severe hyperbilirubinemia JM-103 and BiliChek less reliable at gestations < 35 wks

    68. Because TCB measurements are noninvasive and easy to perform, repeat measurements can easily be obtained. This should reduce the risk of random error from a single measurement and allow plotting of the rate of rise of the bilirubin Is skin/tissue bilirubin or blood bilirubin a better predictor of brain bilirubin?

    69. Problems With Existing Studies All done under research conditions – measurements obtained by specially trained nurses or research technicians  When done routinely by many nursing staff, accuracy and precision will be poorer Some studies used multiple measurements on the same infants, thus measurements are not independent

    70. Additional Data Needed for TcB Measurements Infants with TSB >15mg/dL Infants receiving phototherapy Measurements after phototherapy has been discontinued Low birth weight infants

    71. CPT and CLIA re TcB CPT code 88400 – Bilirubin, total, transcutaneous CLIA certification issues Not a “waived test” but not an In Vitro Diagnostic Device (IVD). Does not analyze body fluids Is a screening device that measures intensity of color using light

    72. Conclusions BiliChek or JM-103 will substantially reduce number of TSB obtained in newborn nursery Both have acceptable diagnostic accuracy when used as a screening device to place infant in a risk category for follow up or to obtain TSB In some populations may not be able to identify the precise bilirubin level with an acceptable degree of accuracy (“the wrong job for the tool”) Will be of tremendous value in pediatricians’ offices Need automatic download from TcB instrument to computer (like Accucheck) to be part of laboratory data base and accessible to practitioners

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