715 - Factors Associated with Clinical Trial enrollment of neOnates in ARkansaS (FACTORS)

Publication Number: 715.4967

Megha Sharma, University of Arkansas for Medical Sciences, Little Rock, AR, United States; Dannis Armikarina, Arkansas Children's Hospital, Little Rock, AR, United States; Esma Birisci, Bursa Uludag University, Corpus Christi, TX, United States; Porsha Butler, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States; Madison R. McClanahan, Arkansas Children's Hospital, Little Rock, AR, United States; Andrew Tran, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States; Jonathan Chastain, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States; Sherry Courtney, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States; Jennifer Rumpel, Arkansas Children's Hospital, Little Rock, AR, United States; Mario Schootman, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States

Background: Neonatal clinical trials are essential to advancing our knowledge and practice of neonatal care, however concerns over generalizability and effectiveness are well-known. Large portions of the United States, including the South, have limited representation in neonatal clinical trials. By characterizing maternal socio-demographic factors associated with clinical trial participation, we can develop targeted strategies to ensure enrollment of underrepresented populations in states significantly affected by disparities resulting from socio-economic factors.

Objective: As the sole research site in Arkansas conducting neonatal clinical trials, we aimed to identify maternal factors associated with the enrollment of eligible neonates in clinical trials. This includes infants born prematurely at our birth hospital and tertiary referral center.

Design/Methods: Using site screening logs, we conducted a retrospective review of neonates screened for eligibility in clinical trials from February 2020 to April 2024 at the our academic birth hospital and tertiary referral center. We abstracted data on maternal socio-economic and demographic factors from electronic health records, including maternal age, race-ethnicity, insurance, employment, preferred language, drug use, geocoded addresses and zip codes. Data were collected for infants who met eligibility criteria and were ultimately enrolled or declined participation. Chi-square and binary logistic regression were performed to assess differences between eligible and enrolled infants for categorical variables. Continuous variables were evaluated using independent t-tests. Binary logistic regression was conducted to adjust for potential confounders, with results presented as adjusted ORs and 95% CIs to identify independent predictors of enrollment among eligible neonates.

Results: Out of 371 eligible patients, 34% were enrolled in the 11 active clinical trials. Maternal factors such as age, race-ethnicity, insurance status, Area Deprivation Index, distance from the hospital, and employment were not associated with neonatal trial enrollment (all p’s>0.05). However, a non-English maternal language preference was linked to lower enrollment rates among eligible infants.

Conclusion(s): Contrary to common assumptions, our findings indicate no racial or socio-economic disparities in neonatal enrollment in clinical trials in Arkansas. However, language barriers hinder the enrollment of non-English speaking parents, even with the availability of Spanish consent documents. This highlights a critical area for intervention to improve equitable enrollment in neonatal clinical research.

Table 1. Comparison of maternal socio-demographic factors in enrolled vs non-enrolled groups
Comparison of maternal socio-demographic factors in enrolled vs non-enrolled groups

Table 2. Logistic Regression Model for maternal factors associated with neonatal clinical enrollment.
Logistic Regression Model for maternal factors associated with neonatal clinical enrollment.

Table 3. Description of clinical research studies during the study period (2020-2024)
Description of clinical research studies during the study period (2020-2024)