Bhutani VK, Johnson LH, Shapiro SM Kernicterus in sick and preterm infants (1999-2002): a need for an effective preventive approach. Semin Perinatol. 2004 Oct;28(5):319-25. Review.
Bhutani VK, Vilms RJ, Hamerman-Johnson L Universal bilirubin screening for severe neonatal hyperbilirubinemia. J Perinatol. 2010 Oct;30 Suppl:S6-15. doi: 10.1038/jp.2010.98. Review.
Cashore WJ, Oh W, Blumberg WE, Eisinger J, Lamola AA Rapid fluorometric assay of bilirubin and bilirubin binding capacity in blood of jaundiced neonates: comparisons with other methods. Pediatrics. 1980 Sep;66(3):411-6.
Johnson L, Bhutani VK The clinical syndrome of bilirubin-induced neurologic dysfunction. Semin Perinatol. 2011 Jun;35(3):101-13. doi: 10.1053/j.semperi.2011.02.003. Review.
Lamola AA, Eisinger J, Blumberg WE, Patel SC, Flores J Flurorometric study of the partition of bilirubin among blood components: basis for rapid microassays of bilirubin and bilirubin binding capacity in whole blood. Anal Biochem. 1979 Nov 15;100(1):25-42.
Maisels MJ What's in a name? Physiologic and pathologic jaundice: the conundrum of defining normal bilirubin levels in the newborn. Pediatrics. 2006 Aug;118(2):805-7.
O'Shea TM, Dillard RG, Klinepeter KL, Goldstein DJ Serum bilirubin levels, intracranial hemorrhage, and the risk of developmental problems in very low birth weight neonates. Pediatrics. 1992 Dec;90(6):888-92.
Watchko JF, Oski FA Kernicterus in preterm newborns: past, present, and future. Pediatrics. 1992 Nov;90(5):707-15. Review.
Yeo KL, Perlman M, Hao Y, Mullaney P Outcomes of extremely premature infants related to their peak serum bilirubin concentrations and exposure to phototherapy. Pediatrics. 1998 Dec;102(6):1426-31.
Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.