Holm Kristina Garne, Hägi-Pedersen Mai-Britt, Haslund-Thomsen Helle, Nilsson Ingrid, Aagaard Hanne, Maastrup Ragnhild, Ejlertsen Camilla, Petersen Mette, Feenstra Maria Monberg, Kristensen Ingeborg, Brødsgaard Anne
Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense C, Denmark
Faculty of Health Sciences, University of Southern Denmark, Odense M, Denmark.
BMJ Open. 2025 Sep 15;15(9):e100258. doi: 10.1136/bmjopen-2025-100258.
Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants' cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.
The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023-2024) and intervention (2025-2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants' emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.
The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study - First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022-792). The findings will be disseminated through peer-reviewed publications.
NCT06116747.
早产婴儿的父亲希望积极参与并悉心照料自己的孩子。父亲照料对早产婴儿认知和社会发展的积极影响已得到认可。人们越来越意识到在为人父母的早期阶段需要支持父亲，但当他们的婴儿在新生儿重症监护病房时，父亲可能会感到被排斥。在此，我们介绍一项研究方案，该研究涉及开发并在全国实施一项复杂干预措施，以支持早产婴儿的初为人父者在为人父母的早期阶段。
该研究遵循医学研究理事会关于复杂干预措施的框架。将采用多中心、前瞻性、非盲、准实验设计来评估一项针对护士和父亲的基于临床和技术的干预措施的效果。将比较在对照期（2023 - 2024年）和干预期（2025 - 2026年）招募的295名父亲及其伴侣的参与结果。将评估对父母信心、压力、抑郁和情绪以及家庭和反思功能以及婴儿情感和社会发展的影响。将使用定性和定量方法进行全面的过程评估。
该研究已在Clinicaltrials.org注册[编号：NCT0 6 116 747（SUPPORTED研究 - 早产婴儿的初为人父者），于2023年11月3日获批]。丹麦数据保护局已批准该研究（P - 2022 - 792）。研究结果将通过同行评审出版物进行传播。
NCT06116747。
