216 - Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials: A Systematic Review

Poster Number: 216
Publication Number: 216.339

Allison N. Lyle, SEATTLE CHILDREN'S HOSPITAL, Seattle, WA, United States; Henna Shaikh, Perelman School of Medicine at the University of Pennsylvania, Caleta, La Romana, Dominican Republic; Megan Gray, University of Washington School of Medicine, Seattle, WA, United States; Elliott Weiss, University of Washington School of Medicine, Seattle, WA, United States

Background: Representativeness of populations within neonatal clinical trials is crucial to moving the field forward. Although race and ethnicity disparities in research inclusion are well documented in other fields, these are poorly described within neonatology.

Objective: We aimed to report the race and ethnicity of infants included in a sample of recent US neonatal clinical trials. We also aimed to describe variability in this reporting and reporting of other demographic information of participants.

Design/Methods: We searched for US neonatal clinical trials entered into Cochrane CENTRAL in 2019. Inclusion determination, data extraction, and quality assessment were performed independently by two individuals with discrepancies adjudicated by consensus.

Results: Twenty-two manuscripts met inclusion criteria. Of these, only 13 included any data on race and ethnicity of participants. Together this consisted of 58.4% White, 23.8% Black, 12.3% Hispanic, 1.8% Asian, 0.8% Native American, and 14.6% Other race. Asian, Black, and Hispanic participants were underrepresented, while White participants were overrepresented compared to the US clinical NICU population (Figure 1). There was substantial variability in terminology and methodology of reporting race and ethnicity data (Table 1). Few studies reported SES factors. Geographic representation was heavily skewed toward the northeast, with nearly half of states without representation in these clinical trials (Figure 2).Conclusion(s): Neonatal clinical trials may perpetuate inequality by underrepresenting neonates of color. Compared to the US clinical NICU population, Asian, Black, and Hispanic infants were under-represented in these neonatal clinical trials. Studies varied in the documentation of race and ethnicity. There was minimal reporting of SES factors for infants. There was regional variation in sites included. From these findings we propose a 4-point targeted approach for funders and clinical trialists to address these issues: 1. Prioritize the identification of ways to increase diversity in neonatal clinical trial participation. 2. Agree upon a standardized method to report race and ethnicity of neonatal clinical trial participants. 3. Agree upon a standard set of SES data to collect and report for neonatal clinical trial participants. 4. Prioritize inclusion of participants from all regions of the US within neonatal clinical trials.
Table 1Terms Used to Describe Race and Ethnicity of Participants in Neonatal Clinical Trials
Figure 1Race and Ethnicity of Participants Compared to the Clinical NICU Population