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Randomized Controlled Trial
. 2025 Jun;45(6):797-805.
doi: 10.1038/s41372-025-02318-w. Epub 2025 May 20.

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

M T Alferink #  1 , H Hoeben #  1 , N H Jonkman  2 , J B van Goudoever  3 , A A M W van Kempen  1 , N R van Veenendaal  3 , S R D van der Schoor  4 ; neoPARTNER studygroup
Collaborators, Affiliations
Randomized Controlled Trial

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

M T Alferink et al. J Perinatol. 2025 Jun.

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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Conflict of interest statement

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.

References

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