Abstract
Participation in neonatal randomized controlled trials (RCTs) is associated with improved or equivalent outcomes for infants and is widely viewed as a cornerstone of high-quality neonatal care. Equitable access to research participation is therefore essential to scientific validity, ethical integrity, and generalizability. Although substantial efforts have focused on improving the representation of racial and ethnic minority groups in neonatal research, the inclusion of families who speak languages other than English remains inadequately examined. In this perspective, we synthesize existing evidence on language-based exclusion in pediatric research and present findings from systematic reviews of neonatal RCT protocols and informed consent materials from the National Institute of Child Health and Human Development Neonatal Research Network (1991–2020) and ClinicalTrials.gov (2018–2025). We discuss regulatory, institutional, and structural factors contributing to language exclusion and highlight actionable strategies to promote language-inclusive research, including strengthened federal regulations, investment in equitable language access, language-inclusive study design, systematic documentation of participant language, and meaningful community engagement. Advancing language equity in neonatal research is critical to improving representation, strengthening scientific validity and ensuring that the benefits of research extend to all infants and families.