Background: A wide range of outcomes for infants and parents has been reported in clinical trials testing FCC interventions. This systematic review aimed to identify outcomes, outcome measures, and time-points reported in experimental studies testing FCC interventions in neonatal care units.

Methods: This review included experimental studies investigating FCC interventions in neonatal settings. Database searches were conducted in MEDLINE, EMBASE, CINAHL, Cochrane, PsycINFO, Scopus, JBI, Lilacs, and SciELO, completed in December 2022 and updated in November 2023. Critical appraisal was performed using the JBI checklist for randomized controlled trials, and a narrative synthesis process was used. Outcomes were categorized into the Comet Taxonomy core areas.

Results: The search identified 8787 papers; 42 studies were included in the analysis. Totally, 60 outcomes were identified: 42 infant and 18 parents' outcomes. Outcomes were clustered into 12 domains for infants and five domains for parents and measured by 97 outcome measures. The included studies reported 25 and 27 different time-points for infants and parents, respectively.

Conclusion: This review of studies testing FCC interventions identified heterogeneity and inconsistency of outcomes, outcome measures, and time-points measuring the outcomes. Developing a core outcome set for FCC studies is warranted to benchmark the evidence and identify best-practices.

Impact: This systematic review identified inconsistency of outcomes, outcome measures, and time-points reported in quantitative studies testing family-centered care interventions in neonatal care settings. The lack of standardized outcomes and outcome measures reported in clinical trials makes it difficult to synthesize data to provide conclusive recommendations. This systematic review will contribute to the development of a core outcome set for research testing family-centered care interventions in neonatal care settings.