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

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Enrollment increased: 532 → 915 participants Show 5 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 7 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Study description shortened, about 2,249 words
    • Study title expanded, about 6 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06116747
Lead Sponsor Hvidovre University Hospital
Collaborators: Odense University Hospital, Rigshospitalet, Denmark, Holbaek Sygehus, Slagelse Hospital, Zealand University Hospital, Gødstrup Hospital, Aarhus University Hospital, Aalborg University Hospital, University College Absalon, Lovisenberg Diakonale Hospital
Conditions
(from sponsor)		 Preterm, Father-Child Relations
Related terms Premature Birth
Enrollment 915 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov