Family Centred Healthcare - Zero Separation and Couplet Care

NCT05236023 | Recruiting DMC

• 1 other identifier: P-2021-872
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Post Partum; Infant; Mother-Child Relations; Family

Keywords

preterm infants; zero-separation; Family centred care

Outcome Measures

Primary Outcomes (1)

• Lenght of stay

  Hours of admission from birth to discharge

  At discharge assessed up to 6 months

Secondary Outcomes (6)

• Skin-to-skin contact

  Hours from birth to first skin-to-skin contact

• First breast stimulation

  within the first 3 days

• Family centred care scale

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

• Parental Stress Scale

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

• PedsQL family impact scale

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

Study Arms (2)

Control group

NO INTERVENTION

Group receiving care as usual before the intervention takes place

Intervention group

EXPERIMENTAL

Group receiving zero separation and couplet care

Behavioral: Zero separation and couplet care

Interventions

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• University of Copenhagen: collaborator

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anne Brødsgaard

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

Central Study Contacts

Michella Bjerregaard

CONTACT

+45 24342904; michella.runge.kjoebeloev.bjerregaard.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: February 11, 2022
• Study Start: June 14, 2022
• Primary Completion: April 1, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

DK (1)