P1.200: Neonatal Trials Worldwide: A Comparison of Clinical Trials Across Income Settings

Background: The first month of life accounts for nearly half of all deaths in children under five. Low- and middle-income countries bear a disproportionate burden of neonatal deaths compared to high-income countries. In order to examine the efficiency of the research process, this study analyzes differences in study characteristics among neonatal randomized clinical trials (RCTs) conducted in countries from different incomes levels

Methods: Within NeoCanon, a validated database of all neonatal RCTs, we extracted data for studies published between 2013 and 2022. Data included the country in which the study was conducted, the neonatal problem being addressed, the study design, and the source of funding. RCTs were classified according to The World Bank classification system:low-income (LIC), lower-middle, upper-middle, and high-income (HIC). Upper- and lower-middle-income countries were combined into middle-income countries (MIC). Studies conducted in more than one country were categorized as “Multicountry” and assigned to the income group of the plurality of included countries. Descriptive statistics were used to identify the top three problems among each income group. Sample size was categorized into five groups: < 100, 100–200, 201–500, 501–1000, and >1000 participants. A chi-square test was performed to examine differences in trial characteristics across income groups by categorizing trial design, funding source, and sample size.

Results: A total of 3,454 neonatal trials from 87 different countries were included in the analysis. RCT characteristics varied significantly by income, especially regarding the top three problems studied (Figure 1), as well as trial design, funding sources and sample size. The top three HICs by number of trials were the United States (n=503), Italy (n=122), and Australia (n=118). Among MICs, they were India (n=410), Iran (n=390), and China (n=277). For LICs, they were Uganda (n=13), Ethiopia (n=8), and Guinea-Bissau (n=6). HICs and MICs most frequently employed parallel and crossover designs, while LICs were more likely to use cluster designs. RCTs from HICs were more commonly funded by federal sources, whereas those from MICs relied more heavily on other sources such as hospitals, universities, or had no reported funding.LICs were primarily funded by federal and foundation sources, and 67% of this federal funding was from external government support. Additionally, LICs had a higher median sample size compared to both HICs and MICs (Table 1), which may be related to the frequency of cluster design trials.

Conclusion: An examination of neonatology RCTs over a ten-year period shows differences in trial design, clinical problem targeting, and funding according to country income. In order to optimize the efficiency of the research process, further work should determine how funds and resources are utilized to have a better understanding of how healthcare burdens vary between countries from different economic and social backgrounds.