Family Centred Healthcare - Zero Separation and Couplet Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCopenhagen University Hospital, Hvidovre

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Zero separation and couplet care

    Behavioral

    The essence of the intervention is that treatment-requiring mother-infant dyads are admitted together and receives couplet care provided by neonatal nurses. The nurses will be educated for the intervention by participating in a two-day course about postpartum observations, treatment and care; and participate in education about family-centred care and family-focused nursing.

Treatment groups

556 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Lenght of stay

Hours of admission from birth to discharge

Time frame
At discharge assessed up to 6 months

Secondary outcomes

1

Skin-to-skin contact

First skin-to-skin contact

Time frame
Hours from birth to first skin-to-skin contact
2

First breast stimulation

Number of hours until mothers first breast tension

Time frame
within the first 3 days
3

Family centred care scale

Family Centered Nursing Scale consists of seven statements that focus on the way nurses work and whether the nurses' work is performed in accordance with the principles of Family Centered Nursing. 7 items using a 5 point scale from not at all important to very important.

Time frame
At discharge assessed up to 6 months and four months after discharge
4

Parental Stress Scale

Measures parental stress, 18 items, The item statements are rated for agreement by parents using a 5-point response scale (1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree)

Time frame
At discharge assessed up to 6 months and four months after discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Copenhagen University Hospital, Hvidovre

Lead sponsor

University of Copenhagen

Collaborator