NCT05236023 Family Centred Healthcare - Zero Separation and Couplet Care
| NCT ID | NCT05236023 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Hvidovre |
| Condition | Premature Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 556 participants |
| Start Date | 2022-06-14 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 556 participants in total. It began in 2022-06-14 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Anne Brødsgaard
STUDY CHAIR
Copenhagen University Hospital, Hvidovre
Frequently Asked Questions
Who can join the NCT05236023 clinical trial?
This trial is open to participants of all sexes, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05236023 currently recruiting?
Yes, NCT05236023 is actively recruiting participants. Contact the research team at michella.runge.kjoebeloev.bjerregaard.01@regionh.dk for enrollment information.
Where is the NCT05236023 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT05236023 clinical trial?
NCT05236023 is sponsored by Copenhagen University Hospital, Hvidovre. The principal investigator is Anne Brødsgaard at Copenhagen University Hospital, Hvidovre. The trial plans to enroll 556 participants.