CDC Statement on Study Results of Product Containing Nonoxynol-9

Abstract

SICKLE CELL DISEASE (SCD) IS A COMmon single-gene disorder that affects three of every 1000 black newborns and approximately 50,000 persons in the United States. 1 Children affected with SCD are at increased risk for severe morbidity (e.g., severe hemolytic anemia, splenic dysfunction, pain crises, and bacterial infections) and mortality, especially during the first 3 years of life. 1,2 In 1993, California, Illinois, and New York collectively accounted for approximately 20% of all births to blacks. All three states offer universal newborn screening for hemoglobinopathies. To assess the effectiveness of newborn screening programs for SCD and for receipt of and compliance with early medical interventions (e.g., penicillin prophylaxis and pneumococcal vaccination and other vaccination patterns), a 3-year collaborative follow-up study was conducted from 1995 through 1998 in California, Illinois, and New York. 3 This report summarizes the results of this study, which demonstrate the difficulty in retrospectively finding children who were screened at birth so that data for evaluating program effectiveness can be assessed.The study comprised children born in 1992 and 1993 and in whom SCD was diagnosed during 1992-1993. Follow-up information about these children was ascertained through complementary surveys administered to parents and physicians of affected children. State health departments administered physician surveys, which were mailed to the child's last known provider. Parental sur-veys were administered by Battelle/ Survey Research Associates, Inc., which conducted telephone interviews and, along with the respective health departments, made repeated attempts to locate the children.During 1992-1993, SCD was diagnosed in 1042 children in California (265 cases), Illinois (254), and New York (523). Fourteen children (six in California, three in Illinois, and five in New York) died before the study began. Completed physician surveys were returned for 752 (72%) of the children (144 in California, 254 in Illinois, and 354 in New York). Parental surveys were completed for 252 (24%) children (87 in California, 52 in Illinois, and 113 in New York). When data from both surveys were merged, physician and parental surveys were completed for 184 (18%) children.Among physician respondents, 575 (76%) reported providing antibiotic (penicillin) prophylaxis to their SCD patients; 253 (44%) patients complied with the prophylaxis antibiotic regimen. One hundred eighty-nine (25%) patients received pneumococcal vaccine, and 179 (24%) received at least the first dose of Haemophilus influenzae type b vaccine (Hib).