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ArticleBMJ open2025

Protocol for the SUPPORTED study: a Danish multicentre complex intervention for first-time fathers of preterm infants.

Kristina Garne Holm, Mai-Britt Hägi-Pedersen, Helle Haslund-Thomsen, Ingrid Nilsson, Hanne Aagaard, Ragnhild Maastrup, Camilla Ejlertsen, Mette Petersen, Maria Monberg Feenstra, Ingeborg Kristensen and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06116747 (Strengthening First-time Fathers' Engagement in Early Parenthood When Having a Preterm Infant - The SUPPORTED Study.), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06116747 naenrolling by invitationnot on this map

Strengthening First-time Fathers' Engagement in Early Parenthood When Having a Preterm Infant - The SUPPORTED Study.

TypeinterventionalSponsorHvidovre University HospitalRan2023 to 2027Enrolled532ConditionsPreterm, Father-Child RelationsArmsIntervention
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kristina Garne HolmHans Christian Andersen Children's Hospital, Odense University Hospital, Odense C, Denmark Kristina.holm@rsyd.dk.ORCID http://orcid.org/0000-0002-2730-1167
Mai-Britt Hägi-PedersenRegion Zealand, Primary Care and eHome Hospital, Næstved, Denmark, Denmark.ORCID http://orcid.org/0000-0002-4349-4755
Helle Haslund-ThomsenDepartment of Pediatrics, Aalborg University Hospital, Aalborg SV, Denmark.ORCID http://orcid.org/0000-0002-5260-9155
Ingrid NilssonDanish Committee for Health Education, Copenhagen, Denmark.
Hanne AagaardLovisenberg Diaconal University College, Oslo, Norway.
Ragnhild MaastrupDepartment of Neonatology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Capital Region of Denmark, Denmark.ORCID http://orcid.org/0000-0001-8719-5717
Camilla EjlertsenDepartment of Public Health, Aarhus University, Aarhus, Denmark.
Mette PetersenDepartment of Pediatrics and Adolescent Medicine, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, Denmark.
Maria Monberg FeenstraDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.
Ingeborg KristensenDepartment of Nursing and Health, Aarhus Universitet, Aarhus, Denmark.
Anne BrødsgaardDepartment of Health and Society, Roskilde University, Roskilde, Region Zealand, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFathers 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT06116747.

Indexed as

FathersInfant, PrematureAdultDenmarkFather-Child RelationsFemaleHumansInfant, NewbornIntensive Care Units, NeonatalMaleMulticenter Studies as TopicProspective StudiesChildFamilyHealthNEONATOLOGYNursing CareParents

Identifiers

PMID40954083
PMCPMC12439153

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.