About 60% of newborns become jaundiced, and about 6% develop total serum bilirubin (TSB) levels at which the American Academy of Pediatrics (AAP) recommends treatment with phototherapy be considered. Decisions about whether to use phototherapy in these newborns should be based upon the risk that the TSB will rise to a potentially dangerous level (> 25 mg/dL) in the absence of treatment, and the efficacy of phototherapy and other interventions at reducing that risk, balanced against their costs and potential harms. Such data, however, are not generally available because these newborns are usually treated well before their TSB reaches 25 mg/dL. In the Northern California Kaiser Permanente Medical Care Program (NC KPMCP) in 1995-96, however, only 27% to 77% of newborns born in different facilities received phototherapy at levels recommended by the AAP. This interfacility variation in adherence to guidelines and the NC KPMCP'S excellent data systems enable a study to estimate the risk of newborns with known hyperbilirubinemia developing a TSB > 25 mg/dL and the efficacy of treatments at reducing that risk. We propose a nested case-control study within a cohort of newborns > 2000 g birth weight and > 34 weeks gestation born 1995-2004 (N~285,000) with TSB levels of 17-22.9 mg/dL at > 48 hours of age (N-16,140). Cases (N~83) will be those who subsequently developed a TSB ^ 25 mg/dL. Controls will be randomly selected in a 4:1 ratio, frequency matched to cases by TSB in 1 mg/dL strata. Predictor variables, including gestational age, breast-feeding, and most recent changes in weight and TSB levels, will be analyzed using multivariate techniques to control confounding, and combined with the cohort size to estimate absolute risk. Estimated efficacy of treatments, including timing and type of phototherapy and feeding changes, will be combined with these absolute risks to allow estimation of numbers needed to treat for different treatments and infants at various levels of baseline risk. Finally, NC KPMCP databases will be used to explore possible effects of phototherapy on future outpatient service utilization. The results of this study will help make neonatal jaundice guidelines and treatment decisions more evidence based. ? ? ?

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Health Services Organization and Delivery Study Section (HSOD)
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Raju, Tonse N
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University of California San Francisco
Public Health & Prev Medicine
Schools of Medicine
San Francisco
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Newman, Thomas B; Vittinghoff, Eric; McCulloch, Charles E (2012) Efficacy of phototherapy for newborns with hyperbilirubinemia: a cautionary example of an instrumental variable analysis. Med Decis Making 32:83-92
Flaherman, Valerie J; Kuzniewicz, Michael W; Escobar, Gabriel J et al. (2012) Total serum bilirubin exceeding exchange transfusion thresholds in the setting of universal screening. J Pediatr 160:796-800.e1
Davis, Adam Rahn; Rosenthal, Philip; Escobar, Gabriel J et al. (2011) Interpreting conjugated bilirubin levels in newborns. J Pediatr 158:562-565.e1
Usatin, Danielle; Liljestrand, Petra; Kuzniewicz, Michael W et al. (2010) Effect of neonatal jaundice and phototherapy on the frequency of first-year outpatient visits. Pediatrics 125:729-34
Newman, Thomas B; Kuzniewicz, Michael W; Liljestrand, Petra et al. (2009) Numbers needed to treat with phototherapy according to American Academy of Pediatrics guidelines. Pediatrics 123:1352-9
Newman, Thomas B (2009) Data suggest visual assessment of jaundice in newborns is helpful. J Pediatr 154:466; author reply 466-7
Kuzniewicz, Michael; Newman, Thomas B (2009) Interaction of hemolysis and hyperbilirubinemia on neurodevelopmental outcomes in the collaborative perinatal project. Pediatrics 123:1045-50
Newman, Thomas B (2009) Universal bilirubin screening, guidelines, and evidence. Pediatrics 124:1199-202
Kuzniewicz, Michael W; Escobar, Gabriel J; Newman, Thomas B (2009) Impact of universal bilirubin screening on severe hyperbilirubinemia and phototherapy use. Pediatrics 124:1031-9
Kuzniewicz, Michael; Escobar, Gabriel J; Newman, Thomas B (2009) No association between hyperbilirubinemia and attention-deficit disorder. Pediatrics 123:e367-8

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