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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 29.32

+4.6%

Oct 31 9:30 AM EDT

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To: STLMD who wrote (1989)	5/3/1998 3:11:00 PM
From: JanyBlueEyes	of 5736

Bilirubin Management Not Set In Stone When Chromatics did there determination of the market size they not only used numbers from data made available by the World Health Organization and the American Academy of Pediatrics, but also independent market studies commissioned by the company and business proposals from potential marketing partners. By obtaining real numbers from independent market studies and from companies who actually have numbers they base their business proposals on, IMO, Chromatics' numbers have better research behind them. This following is taken from the American Academy of Pediatrics aap.org Pediatrics Volume 94, Number 4 October, 1994 It clearly states that there has been a long-standing controversy regarding the monitoring and treatment of hyperbilirubinemia because concentrations of bilirubin considered harmful differ by ethnic groups or geographic locations. It also states that this practice parameter is not intended to establish a guideline for all physicians or health care providers to use because of the different variables involved in the practice settings and different management necessary due to different races of people and geographic locations. BE SURE TO READ THE BOTTOM PARAGRAPH AND REMEMBER: THIS IS FROM THE AMERICAN ACADEMY OF PEDIATRICS. ============= Management of Hyperbilirubinemia in the Healthy Term Newborn Provisional Committee for Quality Improvement and Subcommittee on Hyperbilirubinemia Each year approximately 60% of the 4 million newborns in the United States become clinically jaundiced. Many receive various forms of evaluation and treatment. Few issues in neonatal medicine have generated such long-standing controversy as the possible adverse consequences of neonatal jaundice and when to begin treatment. Questions regarding potentially detrimental neurologic effects from elevated serum bilirubin levels prompt continuing concern and debate, particularly with regard to the management of the otherwise healthy term newborn without risk factors for hemolysis.[1-16] Although most data are based on infants with birth weights >2500 g, "term" is hereafter defined as 37 completed weeks of gestation. .....It is not known at what bilirubin concentration or under what circumstances significant risk of brain damage occurs or when the risk of damage exceeds the risk of treatment. Concentrations considered harmful may vary in different ethnic groups or geographic locations and may be lower outside North America or northern Europe. Reasons for apparent geographic differences in risk for kernicterus are not clear...... ......There are no simple solutions to the management of jaundiced neonates. Continuing uncertainties about the relationship between serum bilirubin levels and brain damage as well as differences in patient populations and practice settings contribute to variations in the management of hyperbilirubinemia. Early postpartum discharge from the hospital further complicates the management of jaundiced newborns, because it places additional responsibilities on parents or guardians to recognize and respond to developing jaundice or clinical symptoms...... 9. Approximately one third of healthy breast-fed infants have persistent jaundice after 2 weeks of age......... DOCUMENTATION This practice parameter is designed to assist the pediatrician and other health care providers by providing a framework for the management of hyperbilirubinemia in the healthy term newborn. It is not intended to replace the physician's clinical judgment or to establish a single protocol applicable to all such newborns with hyperbilirubinemia. It is understood that some clinical problems may not be adequately addressed by the practice parameter, which cannot be considered to represent an exclusive standard of care. Physicians are urged to document their management strategies, including any significant deviation from these or other guidelines and the rationale for the course of action taken. Finally, all physicians and other health care providers caring for jaundiced newborns are encouraged to continue appraising and incorporating into their practices new scientific and technical advances as clinical evidence of their effectiveness becomes established.

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