Actively Recruiting
Evaluation of a Family-centred Care Intervention Based on Zero Separation and Couplet Care
Led by Copenhagen University Hospital, Hvidovre · Updated on 2024-08-21
556
Participants Needed
1
Research Sites
73 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
This trial focuses on families with newborn infants who require specialized medical care, often resulting in separation of mother and infant after birth. Researchers are studying a family-centred care approach that aims to minimize this separation by providing zero separation and couplet care, where mothers and infants are cared for together. The study evaluates how feasible and acceptable this approach is, and its effects on outcomes like length of infant hospital stay, skin-to-skin contact, breastfeeding initiation, and family wellbeing. The intervention involves admitting mother-infant pairs together in the Neonatal Intensive Care Unit, where neonatal nurses provide combined care for both. Nurses receive special training in postpartum care and family-centred nursing. The study compares this new care model to usual care through a quasi-experimental trial and includes qualitative interviews and a health economic evaluation to assess cost-effectiveness. Participants will be monitored throughout their hospital stay and up to six months after discharge. Researchers will assess length of stay, timing of first skin-to-skin contact, breastfeeding start, family stress, depression, and quality of life using questionnaires and scales. Data confidentiality and ethical standards are maintained. The study is expected to inform improvements in nursing practices and public health by promoting family-centred care in neonatal settings.
CONDITIONS
Brief Title
Family Centred Healthcare - Zero Separation and Couplet Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers with a treatment-requiring condition such as preeclampsia, bleeding, psychological diagnoses, discontinued milk production, or infection.
- Infants born at or after 28 weeks of gestation with a treatment-requiring condition such as respiratory distress (including mechanical ventilation), hyperbilirubinemia, infection, or low blood sugar.
You will not qualify if you...
- Healthy mothers who do not need care and have an infant admitted to the NICU.
- Mothers admitted to an adult intensive care unit due to severe illness, such as severe preeclampsia with spasms, severe bleeding of 4-5 liters, or severe HELLP syndrome.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of hospital stay, typically around 7 days but ranging from 24 hours up to three months
Participants receive zero separation and couplet care, where treatment-requiring mother-infant dyads are admitted together and cared for by neonatal nurses trained in postpartum observations, treatment, and family-centred care.
Continuous care during hospital admission
Duration - Up to 6 months after discharge
Participants are followed up to assess family health, wellbeing, and the effects of the intervention up to 6 months after discharge, including assessments of parental stress, depression, and family-centered care.
Assessments at discharge and up to 4 months after discharge
Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
M
Michella Bjerregaard
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here