Background: Family Centered Care (FCC) has been widely adopted as the framework for caring for infants in the Neonatal Intensive Care Unit (NICU) but it is not uniformly defined or practiced, making it difficult to determine impact. Previous studies have shown that implementing the Family Integrated Care (FICare) intervention program for preterm infants in the NICU setting leads to significant improvements in infant and family outcomes. Further research is warranted to determine feasibility, acceptability and differential impact of FICare in the US context. The addition of a mobile application (app) may be effective in providing supplemental support for parent participation in the FICare program and provide detailed data on program component uptake and outcomes.
Methods: This exploratory multi-site quasi-experimental study will compare usual FCC with mobile enhanced FICare (mFICare) on growth and clinical outcomes of preterm infants born at or before 33 weeks gestational age, as well as the stress, competence and self-efficacy of their parents. The feasibility and acceptability of using mobile technology to gather data about parent involvement in the care of preterm infants receiving FCC or mFICare as well as of the mFICare intervention will be evaluated (Aim 1). The effect sizes for infant growth (primary outcome) and for secondary infant and parent outcomes at NICU discharge and three months after discharge will be estimated (Aim 2).
Discussion: This study will provide new data about the implementation of FICare in the US context within various hospital settings and identify important barriers, facilitators and key processes that may contribute to the effectiveness of FICare. It will also offer insights to clinicians on the feasibility of a new mobile application to support parent-focused research and promote integration of parents into the NICU care team in US hospital settings.
Trial registration: ClinicalTrials.gov, ID NCT03418870. Retrospectively registered on December 18, 2017.
Keywords: Family centered care; Family integrated care; Infants; Mobile application; Neonatal intensive care unit; Parents.
Conflict of interest statement
The authors declare that they have no competing interests.
Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: Study Protocol for a Cluster Randomized Controlled TrialKM Benzies et al. Trials 18 (1), 467. PMID 29017578. - Randomized Controlled TrialClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.
Effectiveness of Family Integrated Care in Neonatal Intensive Care Units on Infant and Parent Outcomes: A Multicentre, Multinational, Cluster-Randomised Controlled TrialK O'Brien et al. Lancet Child Adolesc Health 2 (4), 245-254. PMID 30169298. - Randomized Controlled TrialCanadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.
Evaluation of the Family Integrated Care Model of Neonatal Intensive Care: A Cluster Randomized Controlled Trial in Canada and AustraliaK O'Brien et al. BMC Pediatr 15, 210. PMID 26671340. - Randomized Controlled TrialNCT01852695 , registered December 19, 2012.
Improving Quality of Care and Outcome at Very Preterm Birth: The Preterm Birth Research Programme, Including the Cord Pilot RCTL Duley et al. PMID 31566938. - ReviewOur programme of research has improved understanding of parent experiences of very preterm birth, and informed clinical guidelines and the research agenda. Our two-stage …
eHealth Interventions for Parents in Neonatal Intensive Care Units: A Systematic ReviewJ Dol et al. JBI Database System Rev Implement Rep 15 (12), 2981-3005. PMID 29219875. - ReviewWhile heterogeneity across studies precluded meta-analysis, consistent trends across all studies examining parental acceptance of eHealth interventions indicate that pare …
- Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007.
- Franz AR, Pohlandt F, Bode H, Mihatsch WA, Sander S, Kron M, et al. Intrauterine, early neonatal, and postdischarge growth and neurodevelopmental outcome at 5.4 years in extremely preterm infants after intensive neonatal nutritional support. Pediatr. 2009;123(1):e101–e109. - PubMed
- Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013;163(6):1592–1595.e1. - PubMed
- Porcelli PJ, Weaver RG. The influence of early postnatal nutrition on retinopathy of prematurity in extremely low birth weight infants. Early Human Dev. 2010;86(6):391–396. - PubMed