NEOLINGUA-A Review of Language Inclusivity in Neonatology Research Studies

Migrant populations constitute a growing proportion of births globally, with non-native speakers (NNSs) facing barriers to healthcare access. In neonatology, where parental engagement is critical, language barriers may restrict research participation, limiting the generalisability of findings.

To review the documentation of NNSs inclusion in completed interventional neonatal clinical trials involving preterm infants over a 5-year period.

A retrospective structured review following PRISMA 2020 guidelines was conducted via ClinicalTrials.gov to identify completed interventional trials between 1 January 2020 and 31 December 2024 involving preterm infants (< 37 weeks' gestation). Trials were screened for explicit inclusion or exclusion of NNSs. Studies were categorised by NNS inclusivity, intervention type, country of origin, and participant group.

Among the 424 trials identified, 267 met the inclusion criteria. Only 1.5% (n = 4) explicitly included NNSs, all from the United States. A further 14.2% (n = 38) explicitly excluded NNSs, whereas 84.3% (n = 225) made no reference to NNSs in protocols or publications. Exclusion rates were highest in family integrated care studies (48.4%) and trials involving parent-infant dyads (50%).

Documentation of linguistic inclusivity is limited in neonatal interventional research as observed by the results of this study, with most trials providing no information regarding the inclusion or exclusion of NNS. While lack of reporting precludes conclusions of the actual representation of NNS in neonatal research, it raises concerns that may go unrecognised, limiting generalisability of findings and exacerbating health inequities in neonatal care. Integrating language-inclusive recruitment strategies into neonatal research, supported by institutional policy, funding, and researcher training, is essential for equitable research. Further research is required to evaluate effective and sustainable approaches to improving linguistic inclusivity in neonatal clinical trials before widespread implementation in routine research practice.