Actively Recruiting

Phase Not Applicable
All Genders
NCT05236023

Family Centred Healthcare - Zero Separation and Couplet Care

Led by Copenhagen University Hospital, Hvidovre · Updated on 2024-08-21

556

Participants Needed

1

Research Sites

219 weeks

Total Duration

On this page

Sponsors

C

Copenhagen University Hospital, Hvidovre

Lead Sponsor

U

University of Copenhagen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Today mother and infant are routinely separated directly after birth if there is a need of specialised treatment and care, despite of the significant and positive effects of skin-to-skin contact. Thus, there is a need of change in organizing the treatment and care in a way that minimizes separation. The aim is to evaluate the implementation and effect of a complex family-centred intervention based 107 on zero separation and couplet care. The intervention is rooted in the philosophy of family-centred care. Essentially, mother infant dyads will be admitted together, where they will receive couplet care by neonatal nurses. The study comprises a quasi-experimental trial and a qualitative process evaluation including a field study and two interview studies. Finally, a health economic evaluation will be conducted to assess the cost-effectiveness of this complex intervention. The intervention will take place at the Neonatal Intensive Care Unit at Hvidovre Hospital. The nurses will as a part of the intervention be educated to take care of both mother and infant and carry out the intervention. Five families with experiences from the Neonatal Intensive Care Unit and the Maternity Unit participates as patient and public representative in the project, as their experiences and ideas will provide an added value to the project. This study contribute with a new perspective on how to organize the treatment and care of a newborn family in a Neonatal Intensive Care Unit. The study will be the first to examine zero separation and couplet care within sick mother-infant dyads. The study will provide knowledge about how an intervention consisting of zero separation and couplet care can be feasible and acceptable, and what kind of effect and impact it will provide. It is expected that the study as a whole may impact and profile clinical nursing, as well as benefitting public health.

CONDITIONS

Official Title

Family Centred Healthcare - Zero Separation and Couplet Care

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mothers with a treatment-requiring condition such as preeclampsia, bleeding, psychological diagnoses, discontinued milk production and infection.
  • Infant from gestational age 28 weeks with a treatment-requiring condition such as respiratory distress syndrome (with respiratory support including mechanical ventilation), hyperbilirubinemia, infection, and low blood sugar.
Not Eligible

You will not qualify if you...

  • Healthy mothers who does not need care and treatment, and has an infant admitted at NICU.
  • Mothers who are admitted at an adult intensive care unit due to severe sickness (severe preeclampsia with spasm, severe bleeding of 4-5 liter, and severe HELLP syndrome) - counting one-two mothers a year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, 2650

Actively Recruiting

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Research Team

M

Michella Bjerregaard

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Family Centred Healthcare - Zero Separation and Couplet Care | DecenTrialz