RISEinFAMILY project: a study protocol for the integration of families at Neonatal Intensive Care Units (NICUs) to empower them as primary caregivers

Author:

Alferink Milène T.1ORCID,Moreno-Sanz Barbara2,Cabrera-Lafuente Marta2,Ergenekon Ebru3,de Haan Timo R.4,Kempen Anne A.M.W. van1,Lakhwani Jyoti5,Rabe Heike6,Zaharie Gabriela C.7,Pellicer A.2

Affiliation:

1. OLVG

2. La Paz University Hospital: Hospital Universitario La Paz

3. Gazi University Faculty of Medicine: Gazi Universitesi Tip Fakultesi

4. Amsterdam UMC - Locatie AMC: Amsterdam UMC Locatie AMC

5. University of Lusaka

6. Brighton and Sussex University Hospitals NHS Trust: University Hospitals Sussex NHS Foundation Trust

7. Iuliu Hațieganu University of Medicine and Pharmacy: Universitatea de Medicina si Farmacie Iuliu Hatieganu

Abstract

Abstract Background Family Integrated Care (FICare) has demonstrated positive outcomes for sick neonates and has alleviated the psychological burden faced by families. FICare involves structured training for professionals and caregivers along with the provision of resources to offer physical and psychological support to parents. However, FICare implementation has been primarily limited to developed countries. It remains crucial to assess the scalability of this model in overcoming social-cultural barriers and conduct a cost-effectiveness analysis. The RISEinFAMILY project aims to develop an adapted FICare model that can serve as the international standard for neonatal care, accommodating various cultural, architectural, and socio-economic contexts. Methods RISEinFAMILY is a pluri-cultural, stepped wedge cluster controlled trial conducted in Spain, Netherlands, United Kingdom, Romania, Turkey and Zambia. Eligible participants include infant-family dyads admitted to the Neonatal Intensive Care Unit (NICU) requiring specialised neonatal care for a minimum expected duration of 7 days, provided there are no comprehension barriers. Notably, this study will incorporate a value of implementation analysis on FICare, which can inform policy decisions regarding investment in implementation activities, even in situations with diverse data. Discussion 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 registration ClinicalTrials.gov, ID: NCT06087666 Registered on 17.10.2023. Protocol version: 19 December 2022; version 2.2.

Publisher

Research Square Platform LLC

Reference32 articles.

1. O’Brien K, Bracht M, Macdonell K, McBride T, Robson K, O’Leary L et al. A pilot cohort analytic study of Family Integrated Care in a Canadian neonatal intensive care unit. BMC Pregnancy Childbirth [Internet]. 2013 [cited 2023 Jul 27];13 Suppl 1(Suppl 1). Available from: https://pubmed.ncbi.nlm.nih.gov/23445639/.

2. Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial;O’Brien K;Lancet Child Adolesc Health,2018

3. Banerjee J, Aloysius A, Mitchell K, Silva I, Rallis D, Godambe SV et al. Improving infant outcomes through implementation of a family integrated care bundle including a parent supporting mobile application. Arch Dis Child Fetal Neonatal Ed [Internet]. 2020 Mar 1 [cited 2023 Jul 27];105(2):F172–7. Available from: https://pubmed.ncbi.nlm.nih.gov/31227521/.

4. He SW, Xiong YE, Zhu LH, Lv B, Gao XR, Xiong H et al. Impact of family integrated care on infants’ clinical outcomes in two children’s hospitals in China: a pre-post intervention study. Ital J Pediatr [Internet]. 2018 Jun 5 [cited 2023 Aug 8];44(1). Available from: https://pubmed.ncbi.nlm.nih.gov/29871689/.

5. Banerjee J, Aloysius A, Mitchell K, Silva I, Rallis D, Godambe SV et al. Improving infant outcomes through implementation of a family integrated care bundle including a parent supporting mobile application. Arch Dis Child Fetal Neonatal Ed [Internet]. 2020 Mar 1 [cited 2023 Aug 8];105(2):F172–7. Available from: https://pubmed.ncbi.nlm.nih.gov/31227521/.

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