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Family integrated care reduces stress in transferred parents of preterm infants, but not across all families: a stepped-wedge cluster-randomized trial

Abstract

Objective

To assess whether Family Integrated Care (FICare) model including Family-Centered Rounds (FCR) reduces parental stress in neonatal wards.

Study Design

A multicenter, stepped-wedge cluster-randomized trial was conducted in ten level II neonatal wards in The Netherlands (March 2022–December 2023). Participants included parents of 613 infants hospitalized for ≥7 days. The primary outcome was parental stress at discharge (PSS:NICU scale). Secondary outcomes included parental participation, anxiety, trauma, depression, shared decision-making, and bonding.

Results

FICare significantly increased parental participation (P < 0.001) but did not reduce overall stress at discharge (FICare 61.2 vs. SNC 62.5, P = 0.21). Trauma symptoms in partners decreased (P = 0.03), and parents of transferred infants showed reduced stress (P = 0.01).

Conclusion

While FICare improved parental involvement, overall stress reduction was limited, with benefits seen in reduced trauma symptoms in partners and a reduction of stress in parents of transferred infants.

Trial registration

The trial has been registered at Clinical Trials.gov under registration number NCT05343403.

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Fig. 1: Visual overview of the study design.

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Data availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We would like to thank Jos W.R. Twisk (Prof, Department of Biostatistics and Epidemiology, VU, Amsterdam, the Netherlands) for his guidance on epidemiologic questions, as well as James P. Hughes (Prof, Department of Biostatistics, University of Washington, United States) for specific expertise in the design of this trial. We also extend our gratitude to Nanon H.M. Labrie (mother of a preterm infant born at 26 weeks of gestation, PhD) and Sylvia A. Obermann-Borst (mother of a preterm infant born at 29 weeks of gestation and Scientific Coordinator at Care4Neo, Dutch parent and patient support group, MD, PhD) for their valuable insights from a parent’s perspective. We are also deeply grateful to our lead researchers (Ron H.T. van Beek, Lotte H. Hendrikx, Claire A.M. Lutterman, Angelique K.E. Hoffman-Haringsma, Anne M. de Grauw, Ageeth G. Kaspers, Femke de Groof, Martijn J.M. van Brakel, Maarten Rijpert, Fenna Visser) and their research assistants for their dedication and commitment to the implementation of FICare and the inclusion of participants.

Funding

This study was supported by SPIN, the General Paediatrics Research Network of the Dutch Association for Paediatrics, supported by het Cultuurfonds.

Author information

Authors and Affiliations

Authors

Consortia

Contributions

Conceptualisation, methodology, validation and resources: MTA, HH, AAMWvK, JBvG, NRvV, and SRDvdS; software: M.T.A., HH, NHJ and SRDvdS; Data curation: MTA, HH; formal analysis: MTA, HH, NHJ; investigation: MTA, HH, NRvV, and SRDvdS; writing—original draft preparation: MTA, HH, NHJ and SRDvdS; writing—review and editing: HH, MTA, NHJ, AAMWvK, JBvG, SRDvdS and NRvV; visualization: MTA, HH; supervision: AAMWvK, JBvG, and SRDvdS; project administration: MTA, HH, and SRDvdS; funding acquisition: HH and SRDvdS; MTA and HH contributed equally as first authors. Members of the neoPARTNER study group contributed to patient recruitment, data collection, and provision of laboratory samples. All authors have read and agreed to the published version of the manuscript.

Corresponding author

Correspondence to S. R. D. van der Schoor.

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Competing interests

The authors declare no competing interests.

Ethics approval and consent to participate

Ethical approval by the Medical Ethics Review Committee (MEC-U, Nieuwegein, The Netherlands) was received on 6 December 2021. All methods were performed in accordance with the relevant guidelines and regulations. Informed consent was obtained from all individual participants included in the study.

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Alferink, M.T., Hoeben, H., Jonkman, N.H. et al. Family integrated care reduces stress in transferred parents of preterm infants, but not across all families: a stepped-wedge cluster-randomized trial. J Perinatol 45, 797–805 (2025). https://doi.org/10.1038/s41372-025-02318-w

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