RTI uses cookies to offer you the best experience online. By clicking “accept” on this website, you opt in and you agree to the use of cookies. If you would like to know more about how RTI uses cookies and how to manage them please view our Privacy Policy here. You can “opt out” or change your mind by visiting: http://optout.aboutads.info/. Click “accept” to agree.
Hematologic and Immunologic Parameters in Zimbabwean Infants: A Case for Using Local Reference Intervals to Monitor Toxicities in Clinical Trials
Troy, SB., Rowhani-Rahbar, A., Dyner, L., Musingwini, G., Shetty, AK., Woelk, G., Stranix-Chibanda, L., Nathoo, K., & Maldonado, YA. (2012). Hematologic and Immunologic Parameters in Zimbabwean Infants: A Case for Using Local Reference Intervals to Monitor Toxicities in Clinical Trials. Journal of Tropical Pediatrics, 58(1), 59-62. https://doi.org/10.1093/tropej/fmr031
Studies investigating novel therapies in African infants report laboratory adverse events based on reference intervals from white Western infants. However, prior studies have shown that reference intervals differ based on ethnicity and geographic location. We calculated reference intervals for Zimbabwean infants by analyzing the hematologic and immunologic values found in 542 blood samples from 269 HIV-uninfected, black, Zimbabwean infants at 3, 5 and 9 months of age. Substantial proportions of the platelet counts (44%), hemoglobins (19%) and mean corpuscular volumes (41%) were outside published normal ranges. The majority (65%) of hemoglobin values qualified as a United States National Institutes of Health Division of AIDS adverse events. The majority (71%) of CD4% values indicated immunodeficiency by World Health Organization criteria. Hematologic and immunologic reference intervals used to evaluate toxicities in pediatric trials in sub-Saharan Africa need to be reevaluated to account for differences in ethnicity, geographic location, nutrition and socioeconomic status