RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial

This study aims to evaluate the scalability and adaptation of FICare across a broader range of geographical and sociocultural contexts and address its sustainability. Furthermore, it seeks to compare the RISEinFAMILY model with standard care, examining differences in short-term newborn outcomes, family mental health, and professional satisfaction.Trial registrationClinicalTrials.gov NCT06087666. Registered on 17 October 2023. Protocol version: 19 December 2022; version 2.2.
Source: Trials - Category: Research Source Type: clinical trials