A Core Outcome Set for Family-Centered Care in Neonatal Intensive Care Settings: An International eDelphi Study and Online Consensus Meeting

Background/Objectives: Family-centered care (FCC) in neonatal intensive care units (NICUs) can improve infant and family outcomes. Inconsistencies in outcome reporting across FCC trials limits the comparability of findings. Aim: To develop a core outcome set (COS) for evaluating FCC interventions in neonatal intensive care settings. Methods: A list of outcomes was generated through systematic reviews and stakeholder focus groups. A three-round eDelphi study with stakeholders was conducted, followed by an expert consensus meeting. Results: The reviews and focus groups identified 72 outcomes for round 1. Sixty-three healthcare professionals (HCP), 37 parents and five ex-NICU patients completed round 1, with 12 new outcomes suggested. In round 2, 54 HCP, 28 parents and four ex-NICU patients scored 84 outcomes, resulting in the exclusion of 12 low-importance outcomes. In round 3, 45 HCP, 28 parents, and two ex-NICU patients scored the remaining 72 outcomes. Overall, 71% of participants completed all three rounds. Round 3 yielded 48 outcomes that met the predefined consensus criteria and were taken forward to the expert consensus meeting. The final 10 COS outcomes included six outcomes related to parents, namely, bonding with their infant, participation in care, parental readiness for discharge, stress, shared decision-making, and parental knowledge of the infant’s care and treatment, and four outcomes related to infants, namely, infant pain and stress, growth, nosocomial infection, and length of NICU stays. Conclusions: A COS for FCC research and practice in neonatal intensive care settings has been established. Implementation of this COS may improve reporting consistency and strengthen evidence synthesis across FCC trails, thereby better informing care delivery in clinical practice.