482 - Reasons for Non-Inclusion of Eligible Infants within US Neonatal Clinical Trials 2017-2021: a Systematic Review

Poster Number: 482
Publication Number: 482.1606

Background: Clinical trials provide essential evidence to inform medical management, yet many neonatal trials are challenged by insufficient participation. Improving participation in neonatal clinical trials requires understanding the reasons that eligible participants are not included.

Objective: To describe the reasons for non-inclusion of eligible neonates within US clinical trials over a five-year period.

Design/Methods: We performed a systematic search of Cochrane CENTRAL to retrieve full-length, peer-reviewed articles describing clinical trial results in at least 20 human neonates from US NICUs added to the database between 2017-2022. Retrieved articles were independently screened for inclusion by two researchers. Data was extracted on the number of patients eligible for participation and reasons for non-inclusion.

Results: Of the 120 articles that met inclusion criteria, 91 reported the number of eligible neonates. In aggregate, 26,854 neonates were eligible, 11,924 (44.4%) of whom were included in reported results. Most reasons for non-inclusion of eligible neonates were classified as “modifiable” or “potentially modifiable” (Figure 1). Modifiable reasons included factors related to study logistics, such as unmet staffing needs or failure to collect data for enrolled patients (3.2%). Potentially modifiable reasons included parents who declined participation (29.8%) or were not approached (9.3%), clinician refusal to approach (1.5%), participation in another study precluding participation (0.9%), and consent being withdrawn (0.4%). There was wide variation in how studies reported reasons for non-inclusion and the frequency of each reason for non-inclusion (Figure 2).

Conclusion(s): This synthesis of the reasons for non-inclusion in neonatal clinical trials demonstrates that most reasons were modifiable or potentially modifiable. These reasons for non-inclusion may be targets for developing interventions to optimize broader inclusion in neonatal clinical trials. Our findings are limited by gaps and inconsistencies in eligibility reporting and reasons for non-inclusion. More detailed expectations for reporting participant flow (i.e., CONSORT) and greater adherence to such protocols would improve researchers’ understanding of reasons for non-inclusion in neonatal clinical trials.