Actively Recruiting

Phase Not Applicable
All Genders
ID05236023

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

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, 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.
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Treatment

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

Follow-up

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

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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

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