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Search / Trial NCT05236023

Family Centred Healthcare - Zero Separation and Couplet Care

Launched by COPENHAGEN UNIVERSITY HOSPITAL, HVIDOVRE · Feb 1, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Preterm Infants Zero Separation Family Centred Care

ClinConnect Summary

This clinical trial is exploring a new approach to care for mothers and their premature infants in a Neonatal Intensive Care Unit (NICU). Traditionally, mothers and their babies are often separated right after birth if the baby needs special medical attention. This study aims to keep them together as much as possible, using a method called "zero separation" and "couplet care." This means that both the mother and baby will receive care together from specially trained nurses, allowing for important skin-to-skin contact and bonding time, which can be beneficial for both.

To participate in this trial, mothers must have certain health conditions that require treatment, like high blood pressure or bleeding issues, and their infants should be born at 28 weeks or later with health problems such as difficulty breathing or low blood sugar. The study will gather feedback from families who have experience in NICU settings, ensuring that their voices are heard in shaping the care provided. By examining this new care model, the researchers hope to learn how it affects the health and well-being of both mothers and babies, while also considering the costs involved. This trial is a step toward improving family-centered care in NICUs, which could ultimately benefit many families in the future.

Gender

ALL

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

About Copenhagen University Hospital, Hvidovre

Copenhagen University Hospital, Hvidovre, is a leading clinical research institution in Denmark, renowned for its commitment to advancing medical knowledge and improving patient care. As a prominent academic hospital affiliated with the University of Copenhagen, it integrates cutting-edge research with clinical practice, fostering innovation in various medical fields. The hospital is dedicated to conducting rigorous clinical trials, ensuring adherence to ethical standards and regulatory guidelines, while prioritizing patient safety and welfare. With a multidisciplinary approach and access to diverse patient populations, Copenhagen University Hospital, Hvidovre plays a vital role in translating research findings into effective treatments and therapies.

Locations

Hvidovre, , Denmark

Patients applied

0 patients applied

Trial Officials

Anne Brødsgaard

Study Chair

Copenhagen University Hospital, Hvidovre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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