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Clinical Trials in Denmark / NCT06116747
Enrolling by invitation Not applicable

The SUPPORTED Study - First-time Fathers of Preterm Infants.

NCT06116747 · tracked via the Priya Life Science Denmark tracker
Sponsor
Hvidovre University Hospital
Phase
Not applicable
Started
2023-10-31
Last updated
2026-09-18

Condition(s) studied

PretermFather-Child Relations

Investigational drug(s) / intervention(s)

Intervention

Intervention: Support for fathers of preterm infants

Study summary

The purpose is to support first-time fathers of premature infants in early parenthood by promoting early paternal-infant relationships. Improve paternal confidence by involving, knowledge sharing, and guiding them in their premature infants' emotional, nutritional, and developmental needs.

The study operates with two study populations: a) first-time fathers, their premature infants, and families, b) health care professionals working with new families in neonatal intensive care units and maternity units and the families' health visitors from the secondary health care sectors. Seven hospitals located in Denmark's five regions participates.

Four studies address the key questions for the father's involvement in supportive health care: 1) How do fathers experience their participation in father-groups in the NICU, 2) What are the first-time fathers' needs and preferences for supporting health care, 3) Development of an intervention based on the identified need to support the fathers in early parenting, 4) Study the process and effect of the intervention on paternal confidence and stress.

The first question is explored in a qualitative evaluation of an ongoing father-group intervention in a neonatal intensive care unit. The following three questions are studied through an action research approach, identifying first-time fathers' needs for support and the current practices among health professionals towards new first-time fathers of premature infants. Secondly, developing guiding principles for health care professionals to strengthen fathers' partnership in health care. Finally, conducting a quasi-experimental study to evaluate the process and effect of the proposed approaches. The study of this paternal supportive programme, involves perspectives that have not yet been studied in Denmark or internationally.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * First-time fathers of preterm infants * Co-habitating with the mother of the infant * Neonatal Admission for more than seven days * Danish language * Infants born before the 37 week of gestation Exclusion Criteria: * Infant receiving palliative treatment and care * parents not discharged for home * parental mental illness

Primary outcome measure(s)

  • Paternal confidence: Karitane Parenting Confidence Scale (KPCS), — 2 weeks, 4 month, 9 month corrected age
    15 items, 0-1 year postpartum. (Črnčec et al., 2008, 2010).

Trial sites (1)

FacilityCityRegionStatus
Copenhagen University Hospital Amager Hvidovre Hvidovre Hvidovre

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06116747 on ClinicalTrials.gov ↗ ← All trials in Denmark